NuvaRing Breakthrough Bleeding

Photo by feministhealth

If you are using NuvaRing, the vaginal contraceptive ring on an extended regimen, and you experience breakthrough bleeding or spotting [for at least 5 consecutive days], remove the ring for 4 days, store it, and then reinsert the ring. [Use a backup birth control method for those 4 days.]

NuvaRing Acceptability

Willingness to use NuvaRing, from a survey of 691 female college students:

OCPs were the most popular method, with more than 86% of respondents indicating that they were willing to use (53.5%) or were already using (32.8%) OCPs, followed by almost 40% who were willing to use the contraceptive patch. Respondents were least likely to be willing to try the contraceptive vaginal ring (20.4%). Respondents were primarily concerned with pregnancy and STD protection, cost, accessibility and side effects.

A very interesting finding from the survey:

Respondents expressed a twofold preference for oral administration over skin administration, threefold preference for oral administration over injection and more than eightfold preference for oral administration over vaginal administration. However, respondents expressed a strong preference for less frequent administration: more than 60% stated that they liked weekly or monthly administration, compared with 43% who preferred a daily method.

The researchers conclude:

[This study] highlights the importance of considering social context in the development of contraceptive methods and reinforces the need to obtain women's feedback on characteristics of the method in acceptability studies. Indeed, despite the desirable dosing schedule, the monthly regimen alone may be insufficient in motivating young women to use a method that entails vaginal insertion, particularly committed oral contraceptive users. Thus, clinicians should emphasize ways of increasing the acceptability of contraceptive vaginal ring insertion. These might include clinician insertion during the office visit, counseling regarding the ease of self-insertion and suggesting insertion devices such as tampon holders. These measures may increase the acceptability of the contraceptive vaginal ring among young women with busy lifestyles who might benefit from a nondaily method.

NuvaRing vs. the Pill

Nuvaring has the same contraceptive efficacy as the Pill with lower systemic estrogen exposure, more consistent serum estrogen levels and better cycle control, but more local adverse events resulting in higher discontinuation rates.*

A review of twelve randomized controlled trials comparing the combined contraceptive vaginal ring (NuvaRing) and the [30-μg] combined oral contraceptive pill (Pill) found that:

1. Systemic exposure to estrogen with NuvaRing was approximately 50% of that for the Pill (15 μg EE per day vs. 30 μg EE per pill).

(Unfortunately, the influence of the lower EE exposure with the [NuvaRing] on lipid metabolism and coagulation factors remains unknown, as no RCTs between [NuvaRing] and the [Pill] on these important metabolic parameters have yet been published.)

2. Despite the lower systemic exposure to EE, the incidence of estrogen-related adverse events such as breast tenderness, headache and nausea was not significantly different between both treatment modalities.

3. No apparent differences between both methods were found in blood pressure changes, body weight changes or decreasing rates of PMS and dysmenorrhea [pain] complaints.

4. Contraceptive efficacy during the first year of use was excellent and comparable between NuvaRing and the Pill. (This finding should be interpreted with caution, of course, as it is not predictive of the long-term contraceptive results.)

5. Better cycle control with NuvaRing than with the Pill.

6. The vaginal route of hormone administration was associated with higher incidences of local adverse events such as leukorrhea [discharge], vaginal discomfort, vaginitis and ring-related events comprising foreign body sensation, coital problems and expulsions than the oral route.

7. Discontinuation rates due to local and ring-related adverse events were higher in the NuvaRing groups than in the Pill groups.

8. Incidences of serious adverse events were low and comparable in both groups. (However, the number of participants in the studies was too small and the duration of the studies too short to provide any reliable information on the incidence of infrequent but serious adverse events like thromboembolism.)

9. Both NuvaRing and the Pill were found to be highly acceptable methods of contraception.

10. Compared with women not using hormonal contraception, both women using NuvaRing and the Pill reported a global improvement of sexual function.


[*quote slightly modified for clarity]

Stealth Pharma Marketing

***UPDATED***

I was watching Scrubs and I noticed something Ob/Gyn-related. Take a look at these pics from the show's site and see if you can spot it, too:









Interesting example of stealth pharma marketing, but I'm not sure what the point is.

It's not product placement, since the product's name isn't actually shown. As such, unless you're already familiar with this birth control method and its packaging, you wouldn't know it's a Nuvaring ad, and you wouldn't be able to investigate further to learn more about a method that might be beneficial for you.

So then we're left with some type of quasi-subliminal marketing. The manufacturer is repeatedly exposing viewers to an outline of its product logo in hopes of, what? That those so exposed will make an appointment with their Ob/Gyn (how would people even know the ad is for a contraceptive?), draw a picture of the logo or, better yet, build a Play-Doh model, and then ask the doctor to interpret it for them?

What's the point of habituating potential patients to an emblem of your product, if people don't even know what your product is?



UPDATE:

Make sure to read the comments for added perspective. Miko Monkey's TV set insider notes, and Pharma Marketing Blog's John Mack with the definitive report:

The only drug company that has come out of the closet regarding product placement is Organon. In 2005, the Roseland, N.J., firm placed posters for its Nuvaring contraceptive in the backgrounds of NBC's Scrubs and CBS' King of Queens. Since then, it has added ABC's Grey's Anatomy to its list, according to brand director Lisa Barkowski. "A lot of the feedback we get is from healthcare professionals," she said. "They mention it to [our] reps, 'Wow, I saw that poster.' It reinforces in their mind; it makes them think of the product."

Turns out this branding effort is directed to those already familiar with Nuvaring, the physicians. I have to say it never occurred to me we'd be the target audience. But since we are, here are some money saving tips for brand director Lisa Barkowski:

Tip #1: It's our job to know about these products and we don't get our information from TV ads.

Tip #2: It's also our job to, you know, think of all the available methods when recommending a contraceptive to a patient.

Tip #3: Less branding, more providing useful information to your key target audience--people unfamiliar with your product. Like so:

I've been using Nuvaring , after having used Ortho-low and the patch in the past. Both were a pain in the butt, and I learned about Nuvaring after finding out about this blogsite. What a godsend!...I am very grateful that blogs like this are available, as I would have not known about these other methods and wouldn't have been able to reduce my period to four times a year.

Just provide people with clear, complete, and correct information about your product and, if it suits their needs, they will enthusiastically use it. And we will continue to enthusiastically recommend it, not because of any branding efforts on your part, but because, and here's the key point, Nuvaring is a very good, innovative, useful contraceptive method.

And speaking of good and useful things, here's how I'd like my posts to read when I grow up and get a hang of this journalistic writing style thing.

Lastly, check out these new pharma bloggers I discovered via this post:

Pharma Marketing Blog

Pharmalot

Where We Hear From the NY Post And We Are Left Wondering What It "All" Means...Er, "Means"

After noticing several factual inaccuracies about Plan B in a NY Post op-ed, I emailed the columnist:

Ms. Wisse Schachter,

I'm contacting you to alert you to a number of factual mistakes in your op-ed. Briefly:

--Plan B is the "emergency contraception pill[s]", or the "postcoital pill[s]", not the "morning-after pill". [That's an incorrect and misleading term.]

--Plan B is not a pill, it's two pills. Two 0.75 mg levonorgestrel pills, to be exact. [Essential information in view of the new dosage recommendations.]

--Plan B is not basically a double dose of the regular birth-control pill. [Even without defining "regular birth-control pill", Plan B is neither a double dose of the regular progestin-only pill, nor of the EC regimen combination one.]

--Plan B is not associated with "cardiovascular disease, high blood pressure, blood clots, heart attack and strokes." (For that matter, neither are the COC EC regimens.) [In fact, Plan B is the preferred EC method for patients with a history of blood clots or stroke.]

(Full post here.)

Thank you for your time.

ema

Today, Ms. Schachter emails back:

Dear Ema,

Thank you for your message and for taking the time to read and respond to my op-ed.

The side effects listed in my piece are those commonly associated with taking birth control, as I make perfectly clear.

It would have been nice had taken as much time reading the column as you did "rebutting" it.

Regards,
Abby Schachter

First, I appreciate the response.

Second, allow me to address this:

It would have been nice had taken as much time reading the column as you did "rebutting" it.

People, as a rule, when emailing me, assume I'm dense and just say what you mean. Not having to divine intent saves me a lot of time.

I'm not sure, but here's what I think Ms. Schachter's admonition means--"I write a piece focused on the political and social implications of OTC availability of Plan B, and you 1) don't address those issues at all, and/or 2) refute them [not] by pointing out, and correcting, the factual mistakes about Plan B." Correct and incorrect at the same time.

Correct, because all I did was address the factual mistakes about Plan B--what it is, it's side effects, etc. My position (and concern) is that, unless we know the basics about a drug, we cannot have an informed discussion about the politics surrounding it.

Incorrect, because, by pointing out the mistakes about Plan B, I was not rebutting anything; I wasn't presenting any opposing evidence to Ms. Schachter's opinions. The facts about Plan B, like its progestin-only content, are not up for debate. It's not a "she said", "she said" situation. We don't each get a few minutes to make our case. Plan B's composition, or side effects for that matter, are a given, independent of anyone's argument/counterargument [you know, the "science" part].

Last, but not least, we have this:

The side effects listed in my piece are those commonly associated with taking birth control, as I make perfectly clear.

Here's the thing [yes, I know, I'm watching way too much Monk]: 1) the side effects listed in the piece are not those commonly associated with taking birth control, and 2) there's nothing even remotely clear [not to mention correct] about Plan B's side effects in the piece.

There are seven groups of birth control, and over eighty individual methods:

1. Hormonal Group

-Combination Pill

-Progestin-only Pill

-Skin Patch

-Vaginal Ring

-Implants

-Shots

-[Hormone-releasing IUDs]

2. Nonsteroidal Pill Group

-Centchroman

3. Intrauterine Device Group

-Older IUDs

-Frame IUDs

-Frameless IUDs

-[Hormone-releasing IUDs]

4. Barrier and Spermicide Group

-Condom (male, female, and unisex)

-Diaphragm

-Cervical Cap

-Ovès Cap

-FemCap

-Lea contraceptive

[Good pics here.]

-Sponges

-Spermicides

5. Natural Family Planning Group

-Continuous Abstinence

-Outercourse

-Sexual techniques

-Breastfeeding

-Fertility Awareness

6. Sterilization Group

-Male

-Female

7. Emergency Contraception Group

-Combination Pill

-Progestin-only Pill

-Antiprogesterone Pill

-Progesterone production blocker Pill

-IUD

These are the side effects listed in the op-ed:

...mild, such as dizziness, weight gain and irregular periods. ... more serious, if rare - cardiovascular disease, high blood pressure, blood clots, heart attack and strokes.

Ms. Schachter says these are the side effects (emphasis mine) commonly associated with taking birth control. Since we're talking about common side effects, everything after rare (cardiovascular dz, HTN, blood clots, heart attack and strokes) is out.

So we're left with dizziness, weight gain and irregular periods. According to Ms. Schachter, these are the side effects commonly associated with taking birth control. Really? When's the last time your partner's condom use caused you to gain weight?

Okay, I'm being facetious, but you get the point. There's no such thing as side effects ... commonly associated with taking birth control. That's because a method's side effects depend on group, mode of action, dosage, route of administration, risk factors, etc..

Even if Ms. Schachter was only referring to the Hormonal Group when listing the side effects, it's still essential to be accurate.

Cardiovascular disease, high blood pressure, blood clots, heart attack and strokes are not common side effects of methods in the hormonal birth control group. They are rare effects of some of the methods--the combination (estrogen + progestin) ones--in this group. [To give you an idea ...even deaths due to rare events, such as accidents or homicides, are much more common than deaths due to OC-related adverse events.*]

Moreover, the Hormonal Group and the EC Group are not one and the same. The side effects associated with combination methods in the Hormonal Group differ from those associated with combination methods in the EC Group. Cardiovascular disease, high blood pressure, blood clots, heart attack and strokes are not side effects--rare or otherwise--associated with combination (estrogen + progestin) EC regimens. [From my previous post: No deaths or serious complications have been causally linked to emergency contraception.]

Last, but not least, Plan B is a PROGESTIN-ONLY method. Its side effects differ from the combination (estrogen + progestin) methods in the EC Group.

Which brings us to Ms. Schachter's assertion that she made it perfectly clear in her piece that the side effects she lists are commonly associated with (?hormonal/?estrogen-progestin) birth control, in general, not Plan B. I disagree, and here's why.

In a piece

...titled 'PLAN B': What Science Can't Tell Us...

...containing the statement But it plainly is all about Plan B...

...focused on issues surrounding the approval of OTC sales of Plan B...

...stating that OTC approval of Plan B is troubling because women could get it without the benefit of a doctor's warning about side effects...

Well, approval raises a host of troubling questions. For one: Since it's only a double dose of regular birth control, women over 18 (or girls with fake IDs) could get "the pill" without a prescription - or a doctor's warnings about side effects.

...personalizing the issue of lack of physician counseling about side effects, if Plan B becomes available OTC, by quoting an Ob/Gyn's concerns about losing the opportunity to present medical issues associated with OTC sales of Plan B...

Medical professionals have doubts. Dr. Vivian Roston, an OB-GYN at St. Luke's Roosevelt Hospital, worries that over-the-counter access to emergency contraception [that would be Plan B] means she won't have the chance to educate her patients. "I wouldn't want someone not to have access [to emergency contraception]," she told me. "But then again, you lose the opportunity to present all the medical issues associated with taking a high-dose hormonal drug" [again, Plan B] if a woman doesn't have to see a doctor to get it.

(emphasis mine)

...where the above paragraph--about Dr. Roston's worries that OTC sales of Plan B would rob her of the opportunity to discuss with women medical issues associated with taking Plan B--is immediately followed by an enumeration of side effects...

Of course, some of the risks are mild, such as dizziness, weight gain and irregular periods. But others are more serious, if rare - cardiovascular disease, high blood pressure, blood clots, heart attack and strokes.

it is not at all perfectly clear that the listed side effects are not those associated with Plan B, but rather those associated with some mythical "birth control".

Bottom line: This is not about Ms. Schachter's opinions on OTC sales of Plan B, or my reading comprehension and/or debating prowess. It's about the duty of a publication like the NY Post to present factually accurate medical information to its readers. Or not; in which case the NY Post should have no objection to publishing my article entitled "Plan B Causes Cooties."


*Dialogues In Contraception. Winter 2002;7(7):4

FDA Approves Implanon

Finally:

Implanon, a single rod contraceptive implant that is highly effective for 3 years, has been approved in the United States, with a training and marketing plan designed to avoid some of the problems that plagued Norplant, the last implantable contraceptive available in this country.

About the size of a matchstick, Implanon is made of a soft polymer containing 68 mg of etonogestrel [a progestin] that is slowly released over 3 years at a rate of about 30 mcg/day. In a simple office-based procedure, the rod is inserted subdermally on the inner side of the upper arm and is 99% effective in preventing pregnancy, according to Organon, the manufacturer. Implanon works primarily by suppressing ovulation, but it also thickens cervical mucus, a secondary mechanism, according to Organon, which also markets NuvaRing, the vaginal ring that contains etonogestrel and estrogen.

Approved by the Food and Drug Administration in July, Implanon is the first long-term implantable contraceptive to become available in the United States since 2000 when Wyeth stopped marketing Norplant, the six-rod levonorgestrel implant. Since 1998, Implanon has been approved in more than 30 other countries, where it has been used by about 2.5 million women.

...

"We have been waiting for this for quite some time," Dr. Anita Nelson, professor of obstetrics and gynecology at the University of California, Los Angeles, said in an interview. The availability of a contraceptive with this degree of effectiveness and convenience, which takes about 1 minute to insert in a simple, office-based procedure and lasts for 3 years, should meet some of the unmet needs of women who find compliance a challenge even with monthly options such as vaginal rings.

Dr. Nelson expects that the product's gradual dissemination and the requirement that physicians be trained before they receive Implanon should avoid some of the problems that were associated with Norplant. When Norplant became available, there was "a fair amount of enthusiasm [for an implantable contraceptive] pent up for years" so it was widely prescribed soon after approval, and while training was available, it was not required to obtain the product, she said.

Dr. Andrew M. Kaunitz, professor and assistant chairman of the department of obstetrics and gynecology at the University of Florida Health Science Center, Jacksonville, said that the company's training requirements will lead to greater acceptance of the method by women and physicians, "because the clinicians providing the method will have the knowledge to appropriately counsel women and the skills to appropriately perform insertions."

The Implanon implant is longer, thicker, and slightly more rigid than the Norplant rods, and "because it's a single rod system, it's easier and quicker to insert, but more importantly, it's easy and quick to remove," Dr. Kaunitz said in an interview.

And note this, too:

They [Drs. Kaunitz and Nelson] both emphasized the importance of making sure women considering Implanon understand its impact on menstrual bleeding, as with other progestin-only methods. It is "almost unpredictably unpredictable," Dr. Nelson said, noting that in studies, no patterns of irregular bleeding were identified.

...

Bleeding irregularities were frequent and were the most common reason for choosing to discontinue the contraceptive, in 11% of women. About 4% of patients had implant site complications that included swelling, redness, hematoma, and pain. Nearly 2% had removal complications, which included implants that could not be palpated, a broken or damaged implant, slight migration, difficult localization, and formation of fibrosis, according to Organon.

...

Among heavier women, the failure rate of Norplant increased during the fifth year of use. Women weighing more than 30% above their ideal body weight were not included in Implanon trials, but Dr. Monroe said postmarketing data provided no clear evidence that failure was higher in overweight women. The label states that health care providers and patients should be aware that it is unknown whether effectiveness is lower in women over 30% above their ideal body weight.

Skip Your Period and Period Control Options

Good AP article on the available options for period control, as well as some coming attractions.

Among the existing methods:

- Seasonale: 30 μg of estrogen (ethinyl estradiol, or EE)/150 μg of progestin (levonorgestrel), taken continuously for 84 days, followed by 1 week off.

- Ortho Evra patch: 0.75 mg estrogen (EE)/ 6.00 mg progestin (norelgestromin) [20 μg estrogen/150 μg progestin per day], one patch per week for 8 or 12 weeks in a row, followed by 1 week off.

- NuvaRing vaginal ring: 2.7 mg estrogen (EE)/11.7 mg progestin (etonogestrel) [15 μg estrogen/120 μg progestin per day], one ring in place for 3 weeks at a time, for 6 or 12 weeks total in a row, followed by 1 week off. [Alternatively, one ring can be left in place for 4 weeks at a time.]

- Depo-Provera [and Depo-subQ provera 104] shot: 150 mg progestin (medroxyprogesterone acetate) [104 mg progestin], one injection four times a year.

One more existing brand worth mentioning is Loestrin 24 Fe. The innovation here is the shortened placebo interval--one estrogen/progestin pill taken for 24 days, followed by one iron-containing placebo pill taken for 4 days. [Of course, if you're already taking the Pill, and you want a shorter placebo interval, you can use your existing brand to do that. Just take 4 placebo pills, instead of the usual 7, followed by a new pack.]

And some newer developments:

- Seasonique: 30 μg of estrogen [EE]/150 μg of progestin [levonorgestrel]), and 10 μg EE, one estrogen/progestin pill taken continuously for 84 days, followed by one estrogen-only pill for 7 days; no placebo interval.

- Lybrel: 20 μg ethinyl estradiol/90 μg levonorgestrel, one estrogen/progestin pill taken daily with no placebo intervals.

- Implanon*: 68 mg progestin (etonogestrel) [~40 μg progestin per day], one-rod implant lasting up to 3 years.

*Just like so many other methods before it (Mirena, Depo-Provera), Implanon has been available for over a decade outside the U.S.. This pretty much insures Implanon's status as a "cutting edge" method over here.

Would You Be Comfortable Using NuvaRing, the Vaginal Ring?

Somewhat surprising news from a study looking at Nuva Ring user characteristics--you don't have to be all that comfortable with touching your genital area to be a satisfied NuvaRing user:

At least 30% of women starting a reversible contraceptive method discontinue use within 6 months, and many women have difficulty using pills consistently. New delivery systems, including the vaginal ring, may be easier to use than traditional oral contraceptives because they require no daily action from users. The vaginal contraceptive ring cycle consists of 3 weeks of continuous ring use followed by 1 ring-free week. In observed trials, the vaginal ring has an efficacy and an adverse-effect profile similar to those of oral contraceptives.

Women's experience with their bodies may affect acceptability, satisfaction and continuation of contraceptives in a complex way. This may be especially salient for use of the vaginal ring, which requires women to touch their genitals for insertion and removal. Thus, clinicians may not offer the vaginal ring as an option because they believe that their patients would be uncomfortable touching their genitals to insert and remove the ring.

Anticipated discomfort may impede willingness to use the vaginal ring. Data from the National Health and Social Life Survey (NHSLS), with a probability sample of 3432 Americans, indicate that 58% of women report never masturbating. The NHSLS also found that 14% of women reported experiencing pain during intercourse. Women who do not masturbate or who report painful intercourse may have more discomfort with genital touching and be less willing to use the ring. Recent use of vaginal contraceptives has been extremely low in the United States; in the 2002 National Survey of Family Growth, less than 1% of current contraceptive users reported using a diaphragm, cervical cap, female condom, sponge or any other vaginal contraceptive. This suggests that vaginal contraception may not be attractive to many American women. This may be due to vaginal contraceptives' lower efficacy and to some women's unwillingness to touch their genitals.

We carried out this study to identify factors associated with vaginal ring satisfaction and continuation. We hypothesized that women who reported greater comfort in touching their genitals, greater frequency of masturbation, more comfort with intercourse and past use of vaginal contraceptives and products would be more likely than others to be satisfied with the ring and continue using it for birth control.

And yet, when it comes to continued NuvaRing use, the study found that:

High user satisfaction and continuation of the vaginal ring for birth control were not associated with prior use of vaginal contraceptives or products, masturbation, discomfort with intercourse or other behaviors that involve genital touching such as waxing and shaving pubic hair or having tattoos and/or body piercings. Neither demographic characteristics nor vaginal experiences identified successful ring users.

Some limitations of the study:

In this study, we did not collect data regarding frequency of vaginal intercourse; therefore, we do not know if this factor is related to satisfaction with ring use. Our findings indicate that most women who are willing to try the vaginal ring as part of a clinical trial are likely to be highly satisfied with the method and to continue using it. Women willing to participate in a randomized clinical trial are not, however, representative of average ring users, so these findings may not be generalizable.

Surrogate Markers and Clinical Risks of Contraceptive Use

Another good article from Contraception: Is some of the information on contraceptive risks in the package inserts accurate and useful, or is it a barrage of innuendo and pseudo-science?

The development of safe and effective contraceptive options for women is the direct result of advances in laboratory-based research, which has provided an important foundation for the development of an evidence-based approach to contraceptive management. This marriage of laboratory and clinical investigation has not only served to better delineate pathophysiological processes but also has expanded our understanding of the mechanisms of therapeutic actions. However, when laboratory-based studies alone are used to explain clinical outcomes, prediction of clinical outcomes can be corrupted by a lack of clinical information and replaced by a process replete with unsupported assumptions, premature declarations and unfounded concern about the safety and effectiveness of therapeutic interventions. Such a disingenuous application of high-quality laboratory investigation is unfortunately now more commonly used to predict clinical risks of contraceptive use. In several instances, warnings and specific language have been included in the package inserts of contraceptives based on nonclinical studies.

Nonclinically based outcome variables, or surrogate markers, are studied to ostensibly better understand the pathophysiological basis of clinical outcomes associated with the use of particular drugs or therapeutic interventions. However, when such surrogate markers are studied to predict clinical outcomes in the absence of data assessing clinical outcomes, they may lead to unsubstantiated clinical predictions. An example of a surrogate marker and its inappropriate application for predicting clinical outcomes is the measurement of the size and number of ovarian follicles among users of oral contraceptive pills. Those pills associated with more numerous and larger ovarian follicles are "assumed" to be less potent and thus place a woman at a potential increased risk for pregnancy while using that pill. However, the presence or absence of follicles has never been actually correlated with contraceptive pill efficacy. Only a direct determination of pregnancy rates among users of specific contraceptive methods can provide meaningful information about the actual effectiveness of a given contraceptive.

Other examples of using surogate markers to predict risk:

Depo-Povera shot and the risk of bone fracture

In the past, the language of the package insert and all emboldened and boxed warnings communicated well-defined clinical risks, such as the increased risk of adverse cardiovascular events in women who smoke and use estrogen-containing oral contraceptives after the age of 35. Unfortunately, the language and warnings of package inserts have increasingly incorporated surrogate marker studies to arrive at pronouncements of clinical risk. For example, a black box warning in the package insert of Depo-Provera CI warns that the use of the product will diminish the calcium stored in bones and that this could cause an increased risk of fracture. Have studies consistently shown reduced bone mineral density among women using Depo-Provera CI? Yes, studies of a wide spectrum of women using Depo-Provera CI have consistently demonstrated reduced bone mineral densitometry measurements among Depo-Provera CI users. But has there been any study that has demonstrated an increased risk of fracture among any women (pre- or postmenopausal) using Depo-Provera CI? The answer is no. The measurement of bone mineral density in reproductive-age women is a surrogate marker with no known clinical relevance. Moreover, the suggestion that women should consider using an alternative method after 2 years of Depo-Provera CI use is not based on scientific or clinical evidence and may cause clinicians to inappropriately switch their patients to less effective contraceptives. Such changes will place women at increased risk for unintended pregnancy and induced abortion.

Finally, the language of the Depo-Provera package insert also suggests that clinicians "test the bones" of women who wish to continue this method for more than 2 years. As bone densitometry has been shown to be ineffective and inappropriate for assessing fracture risk in the vast majority of premenopausal women, what test is being suggested?

The Ortho Evra patch and the risk of serious adverse events

Unfortunately, this trend in drug warnings continues with the recently added language and new warnings incorporated into the package insert of the transdermal patch Ortho-Evra®. The new emboldened warning for Ortho-Evra is not based on studies of clinical outcomes, but rather nonclinical pharmacokinetic studies that have found that women who use the transdermal contraceptive patch have a greater overall exposure (approximately 60%) to ethinyl estradiol than those women who use a conventional oral contraceptive with 35 μg ethinyl estradiol. A recent study by van den Heuvel et al. compared the exposure to ethinyl estradiol among users of the transdermal patch, the vaginal ring (Nuva Ring) and an oral contraceptive containing 30 μg ethinyl estradiol and 150 μg levonorgestrel (Microgynon), and found that although women using the oral contraceptive had higher peak serum levels of estradiol than the other two agents, users of the transdermal patch had an overall higher exposure to estrogen (AUC or "area under the curve") than users of the other two formulations. The authors state that a lower exposure to ethinyl estradiol is desirable because of reduced "estrogen-related side effects..."

However, the term "estrogen exposure" that is used in the above study is actually a surrogate marker that the authors are using to predict the risk of estrogen-related adverse events with these products. No epidemiological data exist that demonstrate that the use of Ortho-Evra® results in higher rates of estrogen-associated adverse outcomes such as thromboembolic events. It is essential to have epidemiological information derived from rigorously performed clinical trials to make such clinical predictions. In the case of the three agents studied, the different doses and delivery systems likely are important for determination in the actual contraceptive effectiveness and safety. To this end, what if the peak concentration of ethinyl estradiol associated with the use of a contraceptive (Cmax) turns out to be the most important predictor of adverse outcomes instead of the area under the curve? Only epidemiological data will provide an accurate comparison of clinical risks between transdermal and other contraceptives. In fact, the new language in the Ortho-Evra® package insert specifically states that it is not known whether the pharmacokinetic differences are associated with an increase in the risk of serious adverse events in women using the contraceptive patch compared with women using oral contraceptives containing 35 μg ethinyl estradiol. If the package insert is meant to provide clinical warning concerning the use of a particular drug, this statement, which appears in various forms throughout the package insert, truly defies logic.

Women who use Ortho-Evra®, or any other estrogen-containing contraceptives, have an increased risk of developing a thrombolic event. However, a greater increase in the risk of such events compared to users of combination oral contraception has thus far not been determined to be present in the more than 5 million women who have used Ortho-Evra®. Unfortunately, the assumption that will be made by many who read the new package insert language, the van den Heuvel et al. study and the resulting press releases is that the transdermal patch is associated with an even higher rate of adverse events because the "area under the (estrogen) curve" was greater than that observed with vaginal ring or oral contraceptive use. Indeed, a recent article in the Wall Street Journal reports that numerous physicians and clinics are actually encouraging women to consider other contraceptive options or to discontinue the use of the patch altogether. Why would clinicians do this without any clinical evidence of an increased risk of adverse events? And why would an organization or agency communicate such information knowing full well the likely response of many women's health care providers?

The article concludes:

[T]here is one fundamental fact that must be in the forefront of contraceptive study and practice: without epidemiological data to support a clinical correlation, outcomes from surrogate marker studies can result in poor clinical practice. The irony is that the women who should be the beneficiaries of these package inserts changes actually become the unknowing victims of poor clinical practice. Recommendations made in the absence of data on clinical outcomes may lead to choices that increase the likelihood of unintended pregnancy.

In addition to the potential harm of using surrogate markers to develop warning statements concerning the risks associated with the patch or any other contraceptive option, another potential adverse outcome of continuing this practice is the eventual loss of confidence in our regulatory agencies and professional organizations to provide accurate information for professionals and consumers alike. The continuing inappropriate use of nonclinical studies to formulate warnings about the safety of contraceptives and other drugs may result in an interpretation to disregard these warnings by professionals and the public that will obscure real clinical risk associated with a particular drug or device. The true risks may be obscured by the continuing barrage of innuendo and pseudo-science on the package inserts of many drugs and devices.

NuvaRing TV Commercial

Last night I saw the new NuvaRing TV ad and found it to be acceptable.

I wasn't too keen on the depiction of women walking around with what looked like a blue hula hoop around their hips. It left the impression of a large, cumbersome device. Which NuvaRing isn't. [If correctly inserted, neither the user, nor her partner should feel it.]

Also, I'm not sure someone unfamiliar with NuvaRing--a vaginal ring--understood its correct placement by viewing the ad. Taking a pill is common knowledge, and the patch ad shows device placement. Maybe they could have shown NuvaRing in situ, on a plastic model.

Or, even better, NuvaRing on parade:



A woman walking down the runway in a bejeweled panty outfit, a la this one Carrie sported in one episode of Sex and the City. Except, instead of sparkly appliques, it could've had a NuvaRing logo. [Do I have a future as an ad person, or what?]

In any case, I am just glad to see another commercial for a contraceptive on TV. Exposing a wider audience to health information is always a positive development.


Technorati tag: NuvaRing

NuvaRing Expulsion Rates

More good news for vaginal ring (NuvaRing) users:

In a year's experience with the NuvaRing contraceptive, 2.3% of women experience an expulsion, according to the results of four large, phase III clinical trials, Marc Kaptein, M.D., and Edio Zampaglione, M.D., said in a poster presentation at the annual meeting of the American College of Obstetricians and Gynecologists.

In a retrospective analysis of 3,333 women and 33,462 cycles, expulsion occurred in 0.5% of cycles, said the researchers from Organon International, which makes NuvaRing.

The proportion of cycles with expulsions decreased with time, likely due to experience. In the first three cycles, 1.7% reported an expulsion. Users were followed for 13 cycles. In the 11th, 12th, and 13th cycles, 0.2% experienced expulsions.

NuvaRing and Weight

Good news for NuvaRing users:

The NuvaRing contraceptive appears to be as effective in women who weigh more than 89.9 kg (198 lbs.) as in women who weigh less, Carolyn Westhoff, M.D., reported in a poster presentation at the annual meeting of the American College of Obstetricians and Gynecologists.

Previous reports have shown higher incidence of pregnancies with other hormonal contraceptive methods among patients weighing more than 89.9 kg. No causal relationship between body weight and pregnancy risk has been shown, said Dr. Westhoff of Columbia University in New York.

Skip Period Regimens

Skip a period, or skipping your period on Yasmin, tricyclics, and NuvaRing are among the most common terms used by the people who find my site via search engines. So, to help these visitors, as well as my regular readers, I've decided to do a post on the regimens used to skip a menstrual period. This way, you'll have all the information in one place.

Before we start, note:

I. What follows is just an outline of the "skipping your period" (extended) regimens.

II. If you use the Pill, it's best to use a monophasic brand.

TIP: To find out if the brand you're using is monophasic, look at the pack. For a 28-day pack, if 21 pills are the same color and contain the same amount of estrogen and progestin, and 7 pills are a different color and are inactive (placebo), it's a monophasic brand.

Note: The 28-day pack, shortened placebo interval (24/4), brands Loestrin 24 Fe and YAZ are monophasics. As are the 84-day pack brand Lybrel and the 91-day pack brand Seasonale. The other 91-day pack brand, Seasonique, is a biphasic.

III. Your menstrual period and withdrawal bleeding are not one and the same thing.

When you use a combination birth control method, like the Pill, you are not skipping a menstrual period. That's because, for as long as you use such a method, you don't have a menstrual period. What you are doing is shifting the frequency of the withdrawal bleeding episode from once a month to once every few months.

The monthly menstrual period and the monthly withdrawal bleed are distinct, unrelated events.

The monthly period is the body-directed shedding of a thickened uterine lining, under the influence of fluctuating endogenous hormone levels, at set intervals (~21 days). The monthly withdrawal bleed is the user-directed artificial destabilization of a thin uterine lining, as a result of deliberately manipulating the dosage of exogenous hormones in the Pill, at arbitrarily set intervals (21 days, 49 days, 84 days, 168 days, or 336 days).

A monthly menstrual period has a [single] biological purpose: to prepare the uterine lining for pregnancy. A monthly withdrawal bleed has no physiological or biological purpose. It's a designer trick, intended mostly to appease politicians and Popes. It's a historical artifact, not a biological requirement.

IV. The most common side effect with an extended regimen is breakthrough bleeding/spotting (BTB).

V. If you plan to skip your period for a special event, it's best to plan ahead.

Extended regimens work best (less/no BTB) if you plan ahead and give your body at least three months to get used to the new regimen. This applies to both these scenarios: a) you're already using one of the methods on a regular regimen and plan to switch to an extended regimen, or b) you're not using any method and plan to start using an extended regimen.

Of course, it's not always possible to plan ahead. So, if you need to skip your period sooner rather than later, ask your doctor about the high dose, progestin-only regimen (e.g., 5 mg norethindrone acetate, 1-3 times daily). This regimen can be started anywhere from 3 weeks (preferably), to 1 week before the event.

VI. Extended regimens offer the same pregnancy protection as regular regimens.

VII. The .pdf links used in the post are to a method's prescribing information.

VIII. Most of the regimens are based on clinical experience.

IX. Finally, your doctor gives you medical advice, your blogger gives you educational information.

Here are the methods and the regimens.

MONOPHASIC PILL (Yasmin)

Yasmin (.pdf) is a combination, monophasic--estrogen (0.03 mg ethinyl estradiol) + progestin (3 mg drospirenone)--birth control pill. All active pills (21 yellow pills) contain the same amount of hormones. The placebo pills, or "sugar" pills (7 white pills) are inert.

Regular regimen: To bleed once a month

Take one active pill [yellow pill for Yasmin] per day for 21 days, followed by one placebo pill [white pill for Yasmin] for 7 days (bleeding). After the last placebo pill start a new pack.

Extended regimen: To bleed once every three months

Take one active pill [yellow pill for Yasmin] per day for 84 days, followed by one placebo pill [white pill for Yasim] for 7 days (bleeding). After the last placebo pill start another 84-day, active pill, cycle. [You'll need four pill packs per cycle for this regimen.]

TIP: To vary the bleeding interval, vary the number of packs you use. For example, to bleed every month and a half you'll need two pill packs. Take one active pill per day for 42 days, followed by one placebo pill per day for 7 days (bleeding). Or, you can start with three pill packs, and take one active pill per day for 63 days, followed by one placebo pill for 7 days (bleeding).

TRIPHASIC PILL (Ortho Tri-Cyclen Lo)

Ortho Tri-Cyclen Lo (.pdf) is a combination, triphasic--estrogen (0.025 mg ethinyl estradiol) + progestin (0.180 mg/0.215 mg/0.250 mg norgestimate)--birth control pill. All 21 active pills (7 white, 7 light blue, and 7 blue) contain the same amount of estrogen. The amount of progestin varies: the 7 white pills have 0.180 mg; the 7 light blue pills have 0.215mg; and the 7 blue pills have 0.250 mg. The placebo pills, or "sugar" pills (7 green pills) are inert.

Regular regimen: To bleed once a month

Take one active pill [7 white + 7 light blue + 7 blue pills for Orto Tri-Cyclen] per day for 21 days, followed by one placebo pill [green pill for Ortho Tri-Cyclen] for 7 days (bleeding). After the last placebo pill start a new pack.

Extended regimen:

To skip one "period" (or delay the bleeding by one week)

A) Take one active pill [7 white + 7 light blue + 7 blue pills for Orto Tri-Cyclen Lo/Ortho Tri-Cyclen] per day for 21 days. When you get to the 7 placebo pills [green pill for Ortho Tri-Cyclen Lo/Ortho Tri-Cyclen] throw them out and instead take the third week of active pills from a new pack [7 blue pills for Ortho Tri-Cyclen Lo/Ortho Tri-Cyclen].

Once you're done, either start a new pack right away (skip bleeding) or wait one week and then start a new pack (delays bleeding by one week).

[Pack #1] 7 white pills + 7 light blue pills + 7 blue pills + [Pack #2] 7 blue pills.
Start a new pack right away/Wait one week, then start a new pack.

B) Take one active pill [7 white + 7 light blue + 7 blue pills for Orto Tri-Cyclen Lo/Ortho Tri-Cyclen] per day for 21 days, followed by one placebo pill [green pill for Ortho Tri-Cyclen Lo/Ortho Tri-Cyclen] for 7 days (bleeding). After the last placebo pill wait for one week*; don't take any pills. Then start a new pack and take the 21 active pills, followed by the 7 placebo pills. [This regimen shifts the bleeding episode by one week during the second month.]

*VERY IMPORTANT: You are not protected against pregnancy during the week you delay taking the next pack. You must use an alternate birth control method (condom, diaphragm, sponge, etc.).

7 white pills + 7 light blue pills + 7 blue pills + 7 green pills.
Wait one week (no pills). [No Pregnancy Protection!]
Start a new pack.

To bleed once every three months

1. Take one active pill [7 white + 7 light blue + 7 blue pills for Orto Tri-Cyclen Lo/Ortho Tri-Cyclen] per day for 21 days. When you get to the 7 placebo pills [green pill for Ortho Tri-Cyclen Lo/Ortho Tri-Cyclen] throw them out and instead start a new pack. Repeat the regimen with the new pack; use 4 packs total. Stop for one week [either don't take any pills, or take the 7 green pills] (bleeding) then restart.

7 white pills + 7 light blue pills + 7 blue pills.
Start a new pack (take active pills only). Repeat [4 packs total].
Wait one week, then start a new pack.

TIP: To vary the bleeding interval, vary the number of packs you use.

Note: This is the regimen most likely to trigger BTB.

2. Take one active pill [7 white + 7 light blue + 7 blue pills for Orto Tri-Cyclen Lo/Ortho Tri-Cyclen] per day for 21 days. When you get to the 7 placebo pills [green pill for Ortho Tri-Cyclen Lo/Ortho Tri-Cyclen] throw them out. Start a new pack backwards, after first discarding the 7 placebo pills from this new pack [7 blue + 7 light blue + 7 white pills for Orto Tri-Cyclen Lo/Ortho Tri-Cyclen]. Repeat the regimen with the next two packs; use 4 packs total. Stop for one week [either don't take any pills, or take the 7 green pills] (bleeding) then restart.

[Pack #1] 7 white pills + 7 light blue pills + 7 blue pills + [Pack #2] 7 blue pills + 7 light blue pills + 7 white pills + [Pack #3] 7 white pills + 7 light blue pills + 7 blue pills + [Pack #4] 7 blue pills + 7 light blue pills + 7 white pills.
Start a new pack backwards (take active pills only). Repeat [4 packs total].
Wait one week, then start a new pack.

3. Start with three new packs (or two). Take the first 7 active pills [white pills for Ortho Tri-Cyclen Lo/Ortho Tri-Cyclen] from each of the three packs, for a total of 21 pills. Then take the next 7 active pills [light blue for Ortho Tri-Cyclen Lo/Ortho Tri-Cyclen] from each of the three packs, or 21 pills total. Finally, take the last set of 7 active pills [blue pills for Ortho Tri-Cyclen Lo/Ortho Tri-Cyclen] from the three packs, or 21 pills total. Stop for one week [either don't take any pills, or take the 7 green pills] (bleeding) then restart.

[Pack #1] 7 white pills + [Pack #2] 7 white pills + [Pack #3] 7 white pills + [Pack #1] 7 light blue pills + [Pack #2] 7 light blue pills + [Pack #3] 7 light blue pills + [Pack #1] 7 blue pills + [Pack #2] 7 blue pills + [Pack #3] 7 blue pills.
Stop for one week, then restart.

SKIN PATCH (Ortho Evra)

Ortho Evra (.pdf) is a combination--estrogen (0.75 mg ethinyl estradiol) + progestin (6.00 mg norelgestromin)--birth control skin patch. It releases 0.020 mg of estrogen and 0.150 mg of progestin per day.

Regular regimen: To bleed once a month

Apply one patch and leave it on for 1 week. At the end of the week, remove the patch, discard it and replace it with a new patch. Do this for 3 weeks in a row. At the end of the third week, remove and discard the last patch and wait for one week; that's the patch-free week (bleeding). Once the week is over, restart the regular [3 weeks:3 patches on/1 week off] patch regimen.

Extended regimen: To bleed every few months

Apply one patch and leave it on for 1 week. At the end of the week, remove the patch, discard it and replace it with a new patch. Do this for 8 weeks (or 12 weeks) in a row. At the end of the eighth week (or twelfth week), remove and discard the last patch and wait for one week; that's the patch-free week (bleeding). Once the week is over, restart the the extended-use [8 weeks:8 patches (or 12 weeks:12 patches) on/1 week off] patch regimen.

Note: Use of the regular patch regimen [3 weeks:3 patches on/1 week off] entails a 60% higher exposure to estrogen than use of a typical combination Pill brand containing 35 μg of estrogen on a regular regimen [21 days on/7 days off]. Although the clinical relevance of this finding is unknown, you should be aware of it before starting an extended patch regimen.

VAGINAL RING (NuvaRing)

NuvaRing (.pdf) is a combination--estrogen (2.7 mg ethinyl estradiol) + progestin (11.7 mg etonogestrel)--birth control vaginal ring. It releases 0.015 mg of estrogen and 0.120 mg of progestin per day.

Regular regimen: To bleed once a month

Insert one ring and leave it in place for 3 weeks in a row. At the end of the third week, remove the ring, discard it and wait for one week; that's the ring-free week (bleeding). Once the week is over, restart the regular [3 weeks on/1 week off] ring regimen.

Extended regimen: To bleed every few months

Insert one ring and leave it in place for 3 weeks in a row. At the end of the third week, remove the ring, discard it and replace it with a new ring right away. Keep the new ring in for 3 weeks in a row. [That's 6 weeks total.] At the end of the third week, remove the ring, discard it and either:

a) wait for one week; that's the ring-free week (bleeding). Once the week is over, restart the extended-use [6 weeks on/1 week off] ring regimen.

b) replace it with a new ring right away. Leave the new ring in place for 3 weeks in a row. At the end of the third week, remove the ring, discard it and replace it with a new ring right away. Keep the new ring in for 3 weeks in a row. [That's 12 weeks total.] At the end of the third week, remove the ring, discard it and wait for one week; that's the ring-free week (bleeding). Once the week is over, restart the extended-use [12 weeks on/1 week off] ring regimen.

TIP: You can also insert one ring and leave it in for 4 weeks in a row, instead of 3 weeks.

[At the end of the fourth week, remove the ring, discard it and replace it with a new ring right away. The rest of the extended regimen is the same as above, except you leave the ring in for 4 weeks, instead of 3 weeks, in a row.]

Note: Use of the regular ring regimen [3 weeks on/1 week off] entails a 50% lower exposure to estrogen than use of a typical combined Pill brand containing 30 μg of estrogen on a regular regimen [21 days on/7 days off]. Although the clinical relevance of this finding is unknown, you should be aware of it before starting an extended ring regimen.


UPDATE: Right after I finished posting I noticed someone found this by using the search term "secrets to delaying menstrual period". Heh, there are no secrets. Just information.

ETA: I've updated the post.

Plan B: Indications For Use

Plan B may, or may not, become available over-the-counter (OTC) depending on what political mood the FDA's in, but you knowing when to use Plan B shouldn't hinge on that.

In July of 2004, Barr Labs resubmitted its application to sell Plan B OTC to women age 16 and older. [No sales to those under 16 because...umm, the planets aren't aligned properly I suppose.]

While we're awaiting the FDA's decision, let's review the indications for Plan B [emergency contraception (EC)] use.

Basically, you use Plan B (EC) anytime you have unprotected intercourse and you don't want to become pregnant.

To help you ascertain if a) you need to use EC, and b) if using EC will be beneficial, you need to ask yourself 3 questions:

1. Did I have unprotected sex in the past 5 days?

[The sooner you take EC the better. So, ideally, you won't wait for 5 days to use EC. Also, it doesn't matter how many times you had unprotected sex, or how many times your partner ejaculated (tsk, tsk, tsk--why are you having recurrent unprotected intercourse?)]

Here are some examples:

You have unplanned sex without protection

Barrier method (condom, diaphragm, modified diaphragm, cervical cap, sponge) breaks, slips, or dislodges

You miss 2-n combination bc pills (or 1 progestin-only one) in a row

The patch (Ortho Evra) is off for more than 24 hrs or more during patch-on weeks; you leave patch on for more then 9 days straight; you're more than 2 days late putting the patch back on [after the patch-free week]

You take out the ring (NuvaRing) for more than 3 hrs during ring-in weeks; you leave ring in for more than 5 weeks in a row; you're more than 2 days late putting the ring back in [after the ring-free week]

Your last progestin-only shot (Depo-Provera) was 14 or more weeks ago

Rape

2. Was my last menstrual period (LMP) less than 4 weeks ago?

3. Was the timing and duration of my LMP normal?

[The questions about your LMP screen for pregnancy. In other words, if you're already pregnant--you have regular, monthly, periods, but you haven't had a period for the past 2 months, or you had a period last month but it wasn't "normal" for you (fewer days, less flow, etc.)--you shouldn't use EC. The reason EC is not indicated is because it will have no effect, not because it will harm the pregnancy. Remember, you use EC *to prevent* a pregnancy. Once you're already pregnant, EC is useless. It will not terminate a pregnancy, nor will it cause birth defects.]

If you answered "Yes" to all three questions, you need to use EC.


Plan B

One important note about the EC pill regimens. For the progestin-only (Plan B) regimen, the label instructs you to take on dose (one pill) as soon as possible after the act of unprotected sex, and a second dose (one pill) 12 hours later. However, most Ob/Gyns will tell you to take both doses (two pills) at the same time [as soon as possible after the unprotected sex, up to 120 hrs, or 5 days]. Outside the U.S., the EC (Levonelle One Step) already reflects this updated regimen--the package contains only one pill.


Levonelle One Step

Once you take EC, if you still do not get a period in 3 weeks, follow-up with your Ob/Gyn for a pregnancy test. Also, very important: If the reason you had to use EC in the first place was a problem with your regular method of birth control--you either don't have one, or you do but you're not using it consistently, either because of side effects, or a change in your lifestyle/health--now is the perfect time to review your bc needs with your doctor.

NuvaRing Ad, Or Curiosity Killed the Cat

Organon has launched a direct-to-consumer TV ad campaign for its birth control vaginal ring, NuvaRing. I must say, I am very curious to see how this commercial looks like. I have a call in to the pharma for more information on where they plan to air the ad.

NuvaRing News

Good news for NuvaRing users. A small study found that ring use is well tolerated and may have a beneficial effect on vaginal health:

The ring was well tolerated; the few genital symptoms reported were generally scored as mild and their incidence was similar to that reported with OC [oral contraceptive] use, with the exception of vaginal wetness.

Increased vaginal wetness was reported with 2.74-fold incidence...in ring users compared with those using OCs (ring, 63% vs OCs, 43%). "Women who reported more vaginal wetness did not differ on laboratory findings from women who did not report this symptom," the authors note.

Laboratory findings showed that the concentration of Lactobacillus colony-forming units positive for hydrogen peroxide (H2O2) also significantly increased during ring use....

The researcher's conclusion:

"This study provides some reassurance that an increase in vaginal wetness reported by a woman using the combination vaginal ring most likely does not represent pathology," the authors write, adding that increased H2O2-producing Lactobacillus concentrations may even indicate a favorable effect on vaginal health by preventing viral and bacterial infections.

A 1992 study also found that using a vaginal ring continuously (up to two months) didn't cause unfavorable changes in the vagina.

This is important information for women who use the ring for menstrual management. Why? Because when you use the ring to skip the fake period, you use a continuous regimen--the ring remains in place for months at a time. In other words, you insert the ring into the vagina and leave it in for either 3 or 4 weeks (twenty-eight days). After that, you remove it and throw it out. Then you replace the old ring, immediately, with a new one. There is no ring-free week between the old and the new ring. You continue to do this for 2-3 months. At the end of that interval you stop using the ring for 7 days (you'll have the fake period during these 7 ring-free days).

In an ongoing extended-wear study, women have been using the vaginal ring (replacing it every 3 weeks) continuously for six weeks, twelve weeks, and twelve months. Preliminary results should be available by the end of the year.*

*Aarts JM, Miller L. Design of an open-label, randomized, multicenter trial of continuous regimens with NuvaRing. Obstet Gynecol. 2003;101(45):145.

Me, Me, Me!

Unfortunately, if you're a woman, it has come to this. To have a shot at receiving proper health care, you better make sure you have a contingency plan:

During the summer of 2002, Noesen was an independent contractor and worked as a "relief" pharmacist at K-Mart pharmacy in Menomonie.

Prior to working at the pharmacy, Noesen told the managing pharmacist that due to his beliefs, he could not fill birth control prescriptions because he believed they could cause an abortion.

The managing pharmacist said Noesen would not have to fill those orders, and that the managing pharmacist would fill them later. There was no discussion of whether Noesen would transfer such a prescription, but the managing pharmacist assumed Noesen would.

A doctor prescribed a young woman Loestrin FE on June 3, 2002, and authorized refills until June 6, 2003.

...

On June 8, 2002, the young woman gave the prescription to the K-Mart Pharmacy to have it on file for future use.

On Saturday, July 6, 2002, the young woman went back to refill the prescription that was already on file.

Noesen was the only pharmacist working when the young woman came in. Noesen asked her if she was using it for birth control purposes. When she replied "yes," he told her that it was against his personal religious beliefs to fill the prescription.
The young woman then asked Noesen where she could go to get it filled. Noesen told the woman that he couldn't provide her with that information. Noesen did not tell the young woman that according to Wisconsin Administrative Code PHAR 7.05(3) it was her right to have the prescription transferred to another pharmacy.

Later that day, the young woman went to a Wal-Mart Pharmacy to have her prescription filled. The Wal-Mart pharmacist called Noesen to get the prescription ordered transferred.

Noesen refused to transfer the prescription based on his religious beliefs.

The young woman then called K-Mart and talked to an assistant store manager who asked if she could wait until Monday to have the prescription filled. The young woman told the assistant manager that she couldn't wait because her prescription cycle would begin on Sunday. The assistant store manager said the managing pharmacist would come in on Sunday to fill the prescription.

The young woman called on Sunday to check on the prescription. The assistant store manager said the managing pharmacist hadn't been in and hadn't filled the prescription. The assistant store manager again asked if she could wait until Monday. She again said "no" and said that she either needed it filled or needed to have the prescription order back so she could fill it somewhere else.

The assistant store manager called the managing pharmacist who was out of town. He told the assistant store manager that if Noesen wouldn't fill the order that he should transfer it. The assistant store manager told Noesen this, but he still refused.

And the reason Mr. Noesen decided to refuse treatment:

Noesen said that the precedent for the case is what mattered to him-so that others could follow their conscience without fear.

"Conscience and worker rights are at the center of the issue, and conscience is at the center of humanity," said Noesen.

What patient? What patient's needs? In Mr. Noesen's world it's all about: Me, Me, Me!

In a more encouraging development, Oregon residents can now purchase birth control online [which makes one wonder, if this trend catches on, who'd be left as an experimental subject for the likes of Mr. Noesen]:

The service is limited to women who live in Oregon and have a credit card and access to a computer with Adobe Acrobat Reader. It requires paying a $35 fee, filling out a medical questionnaire and talking by phone with a nurse practitioner. The service makes three types of contraception available: birth control pills, the Ortho Evra patch and the NuvaRing device.

Skipping Your Period and Google

I don't know if this is a common blogosphere occurrence, but I must say I receive the most interesting questions. A reader wanted to find out more information about skipping her period, or menstrual management (MM) so off to Google she went. And this is what happened:

90% of the results are about menstrual management for developmentally or intellectually disabled women! In fact, in the first three pages of Google hits, the only non-disability-related results are related to you; they all point to this blog or sites about your book.

I realize the menstrual management idea is relatively new and all, but is handling disabled women really the only context in which it's been discussed until now? Nothing about non-disabled women who just don't want their periods? I'm just blown away.

Actually, I had the same reaction when I discovered the dearth of MM information available to women; hence, my decision to write the book. While we wait for it to come out, let's try to fill this informational gap a little bit by, briefly, going over who can benefit from using MM, and then by looking at why you (and, apparently, Google) don't have enough MM information.

Before we start, I must nip this meme in the bud: the MM idea is relatively new. No, it's not! The only thing that's new is women *finally* getting some information about it.

First, the Pill was initially FDA-approved as a MM drug (in 1957), not a birth control one. That came later, in 1960. Second, using hormonal birth control to treat period-related problems (e.g., endometriosis) has been the standard of care for decades. Third, studies of women using the Pill to suppress the monthly [fake] period have been published as far back as the 1970s. [If you think the concept of Seasonale/a trimonthly bleeding episode is new, think again. The women in a 1977 British study used a similar, trimonthly regimen. Interestingly, 82% of those women welcomed the reduction in the number of periods.] And last, but not least, everybody from honeymooning brides to students, and farmers--women with no period-related problems--have been using MM for lifestyle reasons, also for decades (provided their physician was familiar with it). Apropos of physicians: a 2003 Gallup poll commissioned by ACOG (the American College of Ob/Gyns) found that female ob/gyns are nearly unanimous (99%) in the view that menstrual suppression--the daily use of the Pill to stop monthly periods--is safe for their patients. More than half of women ob/gyns have tried menstrual suppression themselves.

Bottom line: MM is not a new idea. It's been in use for decades.

1) Who can benefit from using MM?

A. Women who don't want to have monthly periods

(because they simply don't like to or because they live in societies that consider menstruating women "untouchable")

B. Women who lead an active lifestyle

(women in the military, women who enjoy active sports, women with physically demanding jobs--stay-at-home mothers taking care of small children, shift factory workers, residents and nurses, mail carriers, etc.)

C. Women with period-related health problems

(cramps, heavy periods, endometriosis, seizures, etc., as well as women with various disabilities)

D. Nonmenstruating women

(women using hormonal birth control no longer have menstrual periods, yet they still experience fake period-related health problems--cramps, migraines,etc.)

One important note: there's no connection between sexual activity and using MM. In other words, MM can be equally beneficial to nuns and mothers of five children. (So, if you had any naughty ideas, nice try, but no.)

Bottom line: although disabled women are one group who can benefit from using MM, they're just one of many. In fact, non-disabled MM users are the clear majority. So then, where's the MM information for non-disabled women? Apparently not on Google.

One thing just occurred to me: most physicians who know about MM aren't probably even aware that this information isn't widely available. I certainly wasn't until something happened--I looked for a good lay MM book to recommend--that made me joltingly aware. [In my colleagues' and my defense: I think we live in a bubble. The lay people we come into contact with, our patients, know about MM because we tell them. All the rest, co-workers and friends, also already know since the majority are medical professionals.] As to the health care professionals who don't know about MM, as well as women in general--how can they be expected to be aware of an information shortage when they're not aware the information exists to begin with?

2) Why isn't MM information widely available?

A. Health-care professionals

(too little time spent with patients, some don't know about MM, etc.)

In a survey of nurses and physicians, 43% said they don't prescribe MM drugs because patients don't ask for them and 4% don't prescribe them because of the extra counseling time involved.

B. The government and pharmaceutical companies

(bureaucracy, no interest in changing drug designation from off-label to "on-label", etc.)

A quick primer on the impact of an off-label designation. First, what do "off-label" and "on-label" mean? Here's an example: the antidepressant Zoloft is FDA-approved for treating depression. This is an "on-label" use. [Once a drug is FDA-approved, for whatever indication, physicians can prescribe it for another indication.] While using Zoloft, physicians notice that it's also very effective at treating premature ejaculation and start using it for that as well. This is an "off-label" use. Most drugs are used off-label, and the off-label use is often considered the standard of care. Only drugs that are FDA-approved can be used off-label.

How does the off-label designation impact you? In a major way. It keeps you out of the loop by law. Pharmas are not allowed to distribute information about off-label use directly to consumers. Most often, they don't even volunteer the information to physicians (they can, but usually, only if the physician initiates the inquiry). Unfortunately, since the drug is already FDA-approved and the physicians are already using it, legally, off-label, the drug manufacturer has little incentive to invest in changing the drug designation to "on-label". In other words, there's little incentive to keep you informed.

For example, before Seasonale was FDA-approved in September of last year, MM use of the Pill, although the standard of care, was off-label. In practical terms, this meant that, unless your health-care professional new about MM and elected to share the information with you, it would've been very hard for you to educate yourself about MM. Now that Seasonale is "on-label", you can get some MM information. As in, you can get information about Seasonale and nothing else. Not the over 10 other monophasic Pill brands* with the exact same composition as Seasonale, not about using a triphasic brand for MM (despite the fact that, according to the manufacturer, a triphasic brand is the one most used by American women), and most certainly not a peep about using NuvaRing, the vaginal ring, or other hormonal methods for MM. Remember, only Seasonale is "on-label"; the rest, although identical in the case of the other monophasics, are off-label. And you're not allowed to know anything about them, under threat of great physical harm. [I'm joking, of course. Or am I? After all, it's quite possible your pretty little heads will explode now as a result of exposing you to all this information.]**

C. The media and society

(the message that the menstrual period is more disgusting than any other known and widely advertised body function--acid reflux, gas, impotence, etc.; acceptable to discuss anal sex, vibrators, decomposing bodies, while mentioning the period, not so much)

*Monophasic Pill brands equivalent to Seasonale (same hormone content, different packaging):

Seasonale estrogen 0.03 mg + levonorgestrel 0.15 mg
Femigoa
Femranette
Levlen
Levora 0.15/30
Microgynon 30
Minidril
Monofeme 28
Nordette
Ologyn micro
Ovranette
Stediril 30

*Just so you know, in the book all you get is the actual data. The purpose of the book is to give you complete and correct information about MM, to allow you to know more and live better. It's not to expose you to my personal comments and opinions. Despite their brilliance, they're irrelevant to your health decisions. [That's why I have a blog, in case you were wondering. Wouldn't want to deprive the world of my opinions. And that's also the reason I blog more-or-less anonymously. I'm quite uncomfortable with physicians expressing their personal views right alongside medical information.]

More Birth Control Methods

Never one to pass up a good discussion on birth control, let me see if I can add some information. Before we start, please keep in mind that this is going to be an extremely superficial review. (Just to give you an idea, the page count for my book is ~263 pages. All the methods mentioned in Vanessa's post are covered in detail, over more than 100 pages. So, again, what follows is very brief, and selective.)

First, read the article that inspired the initial post. Now, let's gently correct and add to it.

The U.S. Food and Drug Administration approved the first oral contraceptive pill in 1960...

Actually, the first birth control pill was approved in 1957. That is, it was approved for period control (to manage period-related problems). Only later, in 1960, was it also approved for birth control. (Just in case you were wondering how long this period control thing has been going on.)

"There have been no changes in the pill until the last few years," said Dr. Ted Peskin, professor of obstetrics and gynecology at the UMass Medical School in Worcester. "Just (recently) have all these adaptations to take birth control hormones (come out)."

Um, only if you've been living in the U.S. Most "adaptations" have been around in Europe for over a decade. As a rule, even if a birth control method is developed here and tested on American women, assume it will be available first in Europe, and about 5 to 10 years later here. (Can you tell I have a bit of a bee in my bonnet about this?)

Three-month pill -- This recently FDA-approved oral contraceptive directs women to take the pill daily for three months, rather than three weeks, allowing only four menstrual periods a year. Common brand name: Seasonale.



Vanessa wants to know if she should be excited or freaked out about Seasonale? Very good question, answered in detail in my book. However, since the release date is October (may I just say, "brilliant" marketing to schedule release around the time of a crucial Presidential election) we can't wait that long.

Briefly, when you use the Pill, on the regular birth control schedule (3 weeks on/1 week off), you no longer have a menstrual period. This is normal, and it's the way the Pill works. Again, if you use the Pill for, say, 5 years, you don't have a menstrual period for 5 years. So, when you use Seasonale, your menstrual periods are not affected at all, since you don't actually have any.

What you do have when you use the Pill, on the regular schedule, is a monthly withdrawal bleeding episode. (For clarity, I'll refer to withdrawal bleeding as the fake period.) Your menstrual period and your fake period have nothing to do with each other; they're not one and the same thing. The fake period is an artificial event, caused by manipulating the amount of hormones in the pill. The only reason you get a monthly fake period is because you take a specific dosage. Change the dosage and the monthly fake period is no more.

Moreover, there is no medical or biological reason to have a monthly fake period when you're on the Pill. The reasons the monthly fake period was built in the Pill are "designer" ones: Puritanical politicians, doctors who didn't wash their hands, Catholic Popes, and dead rabbits. (I'm not being flippant; these are actual, historical reasons.) So, when you take Seasonale all you're doing is changing the frequency of the fake period, from monthly to trimonthly. Of course, just knowing about the real and the fake period isn't enough to fully answer our initial question about Seasonale. There are other factors you need to consider before you can make an informed decision, but we have to move on.

Three-month shot -- A progesterone injection, administered by a doctor, that lasts for three months to prevent pregnancy. Common brand name: Depo Provera.

...

Peskin said side effects of the three-month shot could include a slight weight gain of 5 to 10 pounds and irregular bleeding for the first three to six months, followed by no periods after a year.



Only one randomized clinical trial has studied the effect of Depo-Provera on weight. It found no evidence that Depo-Provera increases appetite or weight. On the other hand, several observational studies that looked at this effect have reported conflicting results: some reported weight gain of up to 16.5 lbs after 6 years of use; others reported no weight change.

Regarding the irregular bleeding, about 35% of users experience irregular bleeding, and 27% experience prolonged bleeding during the first 3 to 6 months of use. After one year of use, about 50% of women become amenorrheic (stop bleeding altogether).

The Patch -- A weekly one-and-three-quarter-inch patch that releases hormones through the skin directly into the bloodstream to prevent pregnancy. Women put on a new patch once a week for three weeks, allowing for a menstrual period during the fourth week each month. Common brand name: Ortho Evra.



Ortho Evra is a good method to use if you don't want to remember to take a pill every day. And just because it's a patch, doesn't mean you have a real menstrual period. Just like with the Pill, you only have fake periods when you use the patch. (This is one of the newer methods; it's only been available for ~2 years).

The Ring -- A flexible two-inch diameter ring inserted into the vagina to release hormones for three weeks to prevent pregnancy, allowing for a menstrual period during the fourth week each month. Common brand name: Nuva Ring.

...

"The ring in my practice is very popular because I use it a lot," Power [a Leominster gynecologist] said. "Women can be squeamish at first, but often women who get it, like it."



Two possible reason to be squeamish about NuvaRing: once you insert it, you can still feel it; either you or your partner can feel it during sexual intercourse. For the first scenario, take it out and re-inserted right away. Remember, the ring is not a barrier method, so it doesn't need to fit over the cervix. Second scenario, take it out (and leave it out) while you're making love, and re-inserted once you're done. Very Important: don't leave it out for more than 3 hours! (This ring is also one of the newer methods; it's been available for ~2 years.)

Intrauterine Device -- A small device inserted by a doctor into the uterus to release hormones that prevent pregnancy, which can last five years or more. Common brand name: Mirena.

...

Peskin said an intrauterine device, called IUD, is also a safe, effective form of birth control.

"It got a bad (reputation) in the U.S. because of the previous infection rate, but that's based on old information," Peskin said.


Mirena


GyneFix

I could not concur more with Dr. Peskin: the IUD is one of the best methods of birth control. Despite the fact that sterilization ("having the tubes tied") is the most common method of birth control used by American women, the IUD offers you better pregnancy protection: 0.4 vs. 0.1 first year failure rate. And this only scratches the surface. For years, the Europeans have been using the "next generation" IUDs, GyneFix and GyneFix mini (both frameless IUDs). Bottom line: maybe the IUD is the best method for you, or maybe not. What is unquestionably best for you: to be aware of all the available birth control options, so that you, in consultation with your physician, can make not only an informed decisions, but one that best fits your unique needs.

Finally, one feministing commenter mentioned Pill/patch/ring use and side effects, in particular: diminished sex drive, mood swings, and increased growth of body hair (hirsutism).

Both natural (body-made) and synthetic (man-made) hormones can cause side effects. For example, too much natural estrogen increases your risk of uterine cancer; too much synthetic estrogen increases your risk of blood clot complications. As a rule, most of the side effects of hormonal birth control are "minor" (BTS, breast tenderness, etc.); the life-threatening ones are rare. (However, if you decide to use a hormonal method, you should be aware of all the risks--minor, as well as major ones.) I don't have time to go over all the risks now, but allow me to clarify something about the three aforementioned risks: diminished sex drive, mood swings, and hirsutism.

Female sex drive (libido) is a complex issue. In other words, in men, low testosterone levels = low sex drive. In women, just measuring the testosterone level is a problem. (Women have much lower levels vs. men, and most tests are not sensitive enough to accurately detect them.) Moreover, in women there's no such thing as a "set" relationship between the testosterone level and libido. That's because, in women, sex drive is determined by a number of factors--past sexual experiences, estrogen levels, etc. (In other words, even if you give a woman with low testosterone levels, and a low sex drive, supplemental testosterone, the physiological response can be present--more blood rushes to the vagina--but her sex drive isn't changed--she reports no improvement in sex drive.) But I digress; back to the Pill and its effect on sex drive. Some ongoing Pill users report an increase in sexual thoughts. Some women who discontinued Pill use report reduced sexual thoughts. The [limited] studies available suggest that Depo-Provera (and Lunelle, a combination shot not available in the U.S.) rarely cause loss of sex drive (or depression, for that matter). Bottom line: some women do perceive/experience changes in sex drive and mood when using hormonal birth control; however, a direct relationship between these changes and the hormonal birth control method is not always evident.

Hirsutism, or, in a woman, an increase hair growth in a male pattern, is caused by an excess of "male" sex hormones, like testosterone. (Mind you, both men and women produce testosterone; however, because men produce much higher amounts, testosterone is referred to as a "male" hormone.) So, in order to treat hirsutism you want to lower the testosterone level. Enter the Pill, one of the methods used to actually decrease hirsutism. Again, the Pill decreases hirsutism, it doesn't increase it. The way it does that: by reducing the amount of free testosterone (the free fraction is active; the bound one isn't). Incidentally, this is the same mechanism by which the Pill decreases and improves acne.

OK, enough for today. I'll try to post something about male birth control soon.

Update:
I just realized I left out one "designer" reason for creating a fake period, one that has to do with doctor's shortcomings. (A bit biased in favor of doctors, aren't we?--ed Yes, but only a bit.) I've amended the original text.

A commenter points out that Seasonale was only approved in 2003. Correct. However, Seasonale is not so much a "new" method, as it is a new brand name (over 10 other brands have the exact same formulation), and pack/label. In Europe, Pill packs already carry these labels; even in the U.S. this regimen has been used for decades. Granted, Seasonale's pack looks much nicer than pill strips with the placebo pills cut out, and held together with a rubber band; still it's more of a form novelty vs. a function one. (Contrast this to the patch. Until Ortho Evra came out there was no other brand/method that delivered birth control through the skin.) In any case, I must admit that when I wrote the post it hadn't even occurred to me that what I just mentioned here wasn't common knowledge. Perhaps we in the medical profession haven't done such a good job of educating women about this topic? (I'd rather like to believe I'm wrong about this.)