7 Birth Control Pill Brands You Need To Know

Seasonale and Seasonique, Jolessa and Quasense, Lybrel, Yaz and Loestrin. Between the squirrely brand names, the different types of regimens and the presence or absence of a placebo (hormone-free) interval, knowing which of these newer birth control pill brands is which can get a bit confusing.

To help you figure out which Pill brand might be the one best suited for your needs here's a brief comparison guide of 7 Pill brands you need to be familiar with.

First, an overview.

Type of pills: All these brands are combination pill brands because they have active pills (the pills containing hormones) in the pack with a combination of two hormones--an estrogen [ethinyl estradiol (EE)] and a progestin [either levonorgestrel (LNG), drospirenone (DRSP), norethindrone acetate (NEA) or desogestrel (D)].

Most of the brands are monophasic--each active pill in the pack has the same amount of hormones. Some brands are biphasic--most active pills contain the same hormone amounts, but a few pills have a different amount of only one hormone, EE.

Regimens: With some brands you take the active pills on a regular monthly regimen, other brands have an extended regimen (84 days), and two brands are continuous-use, meaning you take an active pill every day throughout the year.

Placebo interval: The hormone-free interval ranges from the regular one (7 days), to a shortened one (4 or 2 days), to none.

Second, the brands.

Seasonale, Jolessa, and Quasense
(Extended regimen, regular placebo interval.)

These brands have an 84-day active pill cycle, followed by a regular 7-day placebo interval.

Seasonale (Barr Labs)

One active pill [0.03 mg EE/0.15 mg LNG] for 84 days, followed by 7 days of placebo pills.

Seasonale

Jolessa (Barr Labs)

Same as Seasonale, 84 days of active pills [0.03 mg EE/0.15 mg LNG] followed by 7 days of placebo pills.

Jolessa (via)

Quasense (Watson)

Same as Seasonale, 84 days of active pills [0.03 mg EE/0.15 mg LNG] followed by 7 days of placebo pills.

Quasense (via)

TIP #1
Both Jolessa and Quasense are the generics for Seasonale.

Seasonique and Lybrel
(Continuous regimen, no placebo interval.)

These brands have a continuous active pill cycle; one active pill each day of the year. There's no placebo interval.

Seasonique (Barr Labs)

One active pill [0.03 mg EE/0.15 mg LNG] for 84 days, followed by another active pill [0.01 mg EE] for 7 days.

TIP #2
Addition of low-dose EE during the placebo interval provides greater egg development suppression in the ovary.

Seasonique

Lybrel (Wyeth)

One active pill [0.02 mg EE/0.09 mg LNG] taken daily with no placebo interval.

Lybrel (via)

TIP #3

Seasonique and Seasonale may sound alike, but they're not. Note that only Seasonique and Lybrel do away with the placebo pills. And just so we're clear, despite the media hysteria surrounding Lybrel's recent FDA approval, Seasonique was the first approved Pill brand to completely eliminate the placebo interval, not Lybrel.

Yaz and Loestrin 24 Fe
(Monthly regimen, shortened placebo interval.)

These brands have a 24-day active pill cycle, followed by a shortened 4-day placebo interval.

Yaz (Bayer)

One active pill [0.02 mg EE/3 mg DRSP] for 24 days, followed by 4 days of placebo pills.

Yaz

Loestrin 24 Fe (Warner Chilcott)

One active pill [0.02 mg EE/1 mg NEA] for 24 days, followed by 4 days of iron-containing placebo pills.

Loestrin 24 Fe

And as a bonus, two more shortened placebo interval brands you should be familiar with:

Kariva (Barr Labs)

One active pill [0.02 mg EE/0.15 mg D] for 21 days, a placebo pill for 2 days, followed by another active pill [0.01 mg EE] for 5 days.

Kariva

Mircette (Organon/Barr Labs)

Same as Kariva (and Azurette), one active pill [0.02 mg EE/0.15 mg D] for 21 days, then 2 days of placebo, followed by another active pill [0.01 mg EE] for 5 days.

Mircette

TIP #4

Kariva is the generic for Mircette.

Bottom line: If you're familiar with the characteristic features of these newer brands you can better judge which type of Pill will suit you. Use this guide as a starting point when you discuss Pill option with your Ob/Gyn.

I Offer Marketing Advice to Wyeth Via a NYT Critique

The New York Times has an article about extended and continuous use Pill brands, Pill That Eliminates the Period Gets Mixed Reviews.

Pretty much everything in the article is wrong, including the title.

A bit of background, first. Seasonale, Seasonique, and Lybrel are extended/continuous use combination birth control pills. Like regular Pill brands, Seasonale, Seasonique, and Lybrel eliminate the menstrual period for the entire duration of use. Unlike regular brands, extended/continuous use brands also decrease the frequency of, or altogether eliminate (Lybrel), the monthly withdrawal bleeding episode.

Again, the difference between regular pills and extended/continuous use ones is not the presence or absence of a monthly menstrual period. All pills are designed to eliminate periods for as long as a woman takes them. [Keep this in mind the next time you hear or read that Seasonale enables women to have only four periods per year.] The difference is that Seasonale, Seasonique, and Lybrel, on top of eliminating the period, also mostly/altogether do away with the monthly withdrawal bleed.

The monthly menstrual period and the monthly withdrawal bleed are not one and the same thing. They 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.

Now, let's look at the article.

For many women, a birth control pill that eliminates monthly menstruation might seem a welcome milestone.

To women living in the 1950s, perhaps. But since a birth control pill that eliminates monthly menstruation has been in wide use since the 1960s, the shine is off the milestone bloom.

And speaking of over half a century ago, did you know that initially the Pill was submitted to the FDA in 1957 as a treatment for menstrual disorders, and only later, in 1960, as a method of pregnancy protection?

But others view their periods as fundamental symbols of fertility and health, researchers have found. Rather than loathing their periods, women evidently carry on complex love-hate relationships with them.

Some women view their periods as symbols of fertility and health. Others don't. Ergo, those who don't...wait for it...loath their period. You don't say. Also, the fact that different women view their period differently isn't evidence of women carrying on a complex love-hate relationships with their periods. Rather, it's evidence that women are sentient beings who don't all hold the same view on this one particular topic.

This ambivalence is one reason that a decision expected next month by the Food and Drug Administration has engendered controversy. The agency is expected to approve the first contraceptive pill that is designed to eliminate periods as long as a woman takes it.

Please, for the love of the FSM, people [and by "people" I mean NYT reporters] pay attention; this is a very simple concept:

Every single one of the Pill brands in use, from the 1960s to today, is designed to eliminate periods for as long as the woman takes the pill. The first contraceptive pill designed to eliminate periods as long as a woman takes it was submitted for FDA approval in 1957.

What the FDA is expected to approve, is Lybrel, the first pill designed to eliminate the monthly withdrawal bleeding episode for the entire duration of use.

"My concern is that the menstrual cycle is an outward sign of something that’s going on hormonally in the body," said Christine L. Hitchcock, a researcher at the University of British Columbia. Ms. Hitchcock said she worries about "the idea that you can turn your body on and off like a tap."

That viewpoint is apparently one reason some already available birth control pills that can enable women to have only four periods a year have not captured a larger share of the oral contraceptive market.

"It’s not an easy decision for a woman to give up her monthly menses," said Ronny Gal, an analyst at Sanford C. Bernstein & Company.

First, already available extended use Pill brands, like Seasonale, do not, in any way, shape, or form, enable women to have four periods a year. Women who use Seasonale (or, for that matter, a regular Pill brand, or Seasonique, or Lybrel) do not have menstrual periods for the entire duration of use. Zero periods.

Seasonale, Seasonique, and Lybrel have no effect on the frequency of your menstrual period because you don't menstruate when you use the Pill. All these brands do is to decrease the frequency of, or eliminate (Lybrel), the monthly withdrawal bleed.

Second, I agree that ignorance--just like Ms. Hitchcock and Ronny Gal, many people aren't familiar with the basics of menstruation or the difference between a monthly period and a monthly withdrawal bleed--tends to act as a barrier to women making informed health decisions. The way to combat this problem is to educate as many people as possible about all matters menstrual. Starting with uninformed researchers and analysts quoted in the NYT, and the reporters who interview them.

Third, maybe a fine point, but one you should be familiar with if you're a NYT reporter. If you're attempting to gain insight into why women use, or don't use, extended/continuous Pill brands, women who express reservations about not having a monthly period are not your go-to group. Since these women want to have a period, they're not candidates for the Pill, regular or otherwise. Their viewpoint might tell you why some women don't use the Pill, but it won't tell you much about why women who don't mind eliminating their monthly period use, or don't use, an extended/continuous Pill brand.

Doctors say they know of no medical reason women taking birth control pills need to have a period. The monthly bleeding that women on pills experience is not a real period, in fact.

Ugh, no, doctors most certainly do not say something this nonsensical. What they do say is that there's no known medical reason for women taking birth control pills to have a monthly withdrawal bleed. You know, that thing that women on the Pill experience and which is not a real period, in fact.

And studies have found no extra health risks associated with pills that stop menstruation, although some doctors caution that little research has been conducted on long-term effects.

One more time. All Pill brands stop menstruation for the entire time you take the pill. Millions of women have been using the Pill since 1960. It is now 2007. That's 47 years. According to the FDA:

[O]ver the years, more studies have been done on the pill to look for serious side effects than have been done on any other medicine in history....

Oh, and since this is supposed to be an article about pills that stop the monthly withdrawal bleed:

The earliest such study, conducted by Loudon et al. in 1977, reduced the withdrawal bleed frequency to once every 3 months (84 days of continuous pills) in 196 women using a combination OC containing 50 μg EE [estrogen] and 2.5 mg lynestrenol [progestin]. Overall, 82% of women were satisfied with the regimen, which was associated with decreased menstrual and premenstrual symptoms. Many women also missed fewer pills on the extended regimen.

Ms. Chesler, who teaches documentary making at the University of California, San Diego, said she became concerned about efforts to eliminate menstruation when she first heard about the idea several years ago.

"Women are not sick," she said. "They don’t need to control their periods for 30 or 40 years."

Efforts to eliminate menstruation have been on-goingWomen have been using the Pill since the 1960s and Ms. Chesler only heard about it a few years ago? Ah well, better later than never.

And to be clear, the only person saying that healthy women need to control their periods because menses represent some sort of sickens is none other than Ms. Chesler. Projecting much?

The menstrual period is just a body function, and the option to control it is just a tool at your disposal. If you're healthy, you don't *need* to control your period, but you might very well *want* to, not as a way to get rid of Teh Sick, but because it benefits your lifestyle.

The subject has also ignited a debate within the Society for Menstrual Cycle Research, a scientific organization that studies both the medical and social science of menses.

In 2003, the group issued a position statement saying that more research was needed before women could make an informed choice about using pills that suppress their periods.

How hard is it to find a scientific organization familiar with the topic under discussion? Like the fact that all Pill brands suppress the period? Or the fact that women have been using pills that suppress their periods since the 1960s? Or even the fact that the Pill is one of the most studied drugs in the FDA's history? Just because an organization has the words "Menstrual Cycle" and "Research" in its title doesn't automatically make it relevant and worthy of a NYT article mention.

Ms. Hitchcock, a director of the organization, said that although some research has been comforting, she remained concerned that medical science did not fully understand the long-term implications of interrupting women’s periods. The same hormones that work on the menstrual cycles act in the brain, bones and the skin, she said.

"You need to think about whether there are consequences we don’t know about for the whole body," said Ms. Hitchcock, who is with the Center for Menstrual Cycle and Ovulation Research.

Pay attention to Ms. Hitchcock people! She speaketh the truth. If only medical science had a way to understand the long-term implications of pregnancy, breast feeding, or decades of Pill use there might be hope to understand the long-term implications of interrupting women's periods.

Oh, and just in case I haven't mentioned this in the last minute or so, according to the FDA, over the years, more studies have been done on the pill to look for serious side effects than have been done on any other medicine in history.

There has also been a backlash among groups that celebrate the period as a spiritual or natural process, like the California-based Red Web Foundation. "The focus of our group is to create positive attitudes toward the menstrual cycle; suppressing it wouldn’t be positive," said Anna C. Yang, a holistic nurse and executive director of the organization.

Oh, oh, I want to be holistic, too, but apparently I'm not presumptuous enough. Just because you believe having a monthly period is a positive, does not automatically mean suppressing the period is a negative. There are construction workers in the middle of summer, postcall surgeons in the middle of surgery, and stay-at-home mothers in the middle of family life who benefit from period suppression. As are these people:

Many women in the military (>60%) report that menstrual or premenstrual symptoms have affected their ability to perform physical tasks and have created problems with regard to changing, obtaining and disposing of hygiene products....In the United States, tubal sterilization is the most common form of contraception; this large group of sterile women continue to menstruate with no possibility of pregnancy. For all of these women, amenorrhea [no bleeding] through continuous OC use could improve their quality of life.

And just so we're crystal clear [heh, I said crystal. Spiritual enough for you?] on one thing. If you're a modern woman living in an industrialized society, it's perfectly *normal* to have a monthly period. But it's not *natural*; it's not the baseline. For example:

Women 100 years ago began menstruating at the age of 16 years, had their first child at 19.5 years of age and gave birth six times between the ages of 20 and 34 years. As a consequence, they only experienced an average of 160 menstrual cycles during their lives. Modern women begin menstruating much earlier, at an average age of 12.5 years, and have fewer children (two children on average in the United States), which translates into more than 450 menstrual cycles over their lifetime.

Eliminating menstruation is not a completely new concept. Women who take any kind of oral contraceptive do not have real periods.

Because the hormones in pills stop the monthly release of an egg and the buildup of the uterine lining, there is no need for the lining to shed — as occurs during true menstruation.

Aha, so eliminating menstruation is not a new concept, and women who take any kind of oral contraceptive do not have real periods. Moreover, they don't need to have a monthly withdrawal bleed. Wait, what!?

Haven't we just spent 18 paragraphs reading, over and over again, how:

- a birth control pill that eliminates monthly menstruation might seem a welcome milestone

- the FDA is expected to approve the first contraceptive pill that is designed to eliminate periods as long as a woman takes it

- some already available birth control pills enable women to have only four periods a year

- more research is needed before women could make an informed choice about using pills that suppress their periods

Here's the thing. Having correct information about the period, the Pill's mechanism of action, and the difference between menses and withdrawal bleeding is crucial in allowing readers to critically evaluate the article's claim that extended/continuous Pill regimens are getting a mixed review.

Mentioning this information in the 18th paragraph, sandwiched between inaccurate statements, repeated over and over again, is substandard. It almost looks like something you might do if you didn't have any hard data to support your central claim.

Moving on.

Still, since the advent of oral contraceptives in 1960, birth control pills typically have been designed to mimic the natural 28-day menstrual cycle to assure women using the pill that their bodies were functioning normally.

Still, what? Just because brands have been typically designed to mimic the 28-day monthly cycle doesn't mean you can ignore that (1) all Pill brands suppress menstruation for the entire duration of use, and (2) the menstrual period and withdrawal bleeding aren't one and the same thing.

And if we're assigning blame for the fact that scientists sneaked in a monthly withdrawal bleed in the original Pill regimen, let's not forget two of the main reasons for the deception: blunting politicians' regulatory reflexes [ironic, no?], and groveling for Pope Paul VI's acceptance. As I remarked in a previous post:

Heaping the concept that women could also control their menstrual period on top of their fertility was considered just too much for the political, religious, and societal sensibilities of the 1950s. Enter withdrawal bleeding. By building-in this monthly bleeding episode into Pill use, the scientists hoped to ease the "shock". [Remember, what we're talking about here is a female health issue, something that, apparently by definition and divine law, requires final approval from politicians, religious leaders, and as many self-appointed "protectors of women" as we can find. In the 1950s, unfortunately just like today, giving women all this control over their bodies and their health was inconceivable; decisions about female health issues couldn't possibly be left to the women and their health care professionals.]

The pills are usually packaged as regimens of 21 days of hormone pills and 7 inactive pills. The interruption of hormone therapy during the inactive part of the regimen induces bleeding that resembles a mild period but is, in fact, caused by unstable hormone levels.

In recent years, drug makers have come out with new pill regimens that tinker with the 28-day cycle by increasing the number of hormone pills, creating a shorter span of bleeding.

The drug maker Barr caused a sensation in 2003 by introducing Seasonale, a contraceptive regimen packed as 84 hormone pills and 7 placebo pills. Users have "periods" once every three months.

(emphasis mine)

Actually, the recent innovation is the packaging, not the regimen. Extended use regimens have been in use for decades (granted, in a less elegant format--pill strips cut from separate packs, tied together with a rubber band):

The traditional OC regimen is an artifact of [a] bygone era, rather than a scientifically established truth. Clinicians realized from the beginning that OCs could prevent bleeding as long as they are taken, producing a cycle or interval of any desired length

In any case, let's not lose focus. After many paragraphs, we finally have some accurate information, including that Seasonale users have "periods" once every three months. [As opposed to what we were told before, that some already available birth control pills enable women to have only four periods a year.]

But look at comes next:

And the company plans a direct advertising campaign within the next few months for a newer version, Seasonique, which also reduces periods to four a year.

Um, and which period would that be--the period period, or the "period" period?

Seriously now, for the sake of consistency, if not accuracy, once you managed to presented the correct information to your readers, you should stick with it, instead of reverting back to making inaccurate statements.

Seasonique does not reduce periods to four a year, since women using it do not have periods. What Seasonique does do is shift the frequency of withdrawal bleeding from monthly (regular Pill regimen) to four times a year.

Views about menstruation have long been mixed. Some cultures have banished menstruating women to huts or required special baths after periods. Others believed that menstruating women had special powers.

In her diary kept while in hiding from the Nazis, Anne Frank mused about menstruation. "I have the feeling that in spite of all the pain, unpleasantness and nastiness I have a sweet secret," she wrote.

Wyeth’s research indicates that ambivalence toward the menstrual period continues today. A look at the data reveals that half of the women said they found comfort in their periods as an indication that they were not pregnant. Nearly a quarter of the women polled said they were attached to their periods as a natural part of womanhood.

First, discriminating against menstruating women, or, for that matter, heaping unreasonable expectations on them, does not mean that *women* are ambivalent about their period. [And seriously, using the musings of a poor, traumatized girl, hiding from the Nazis as an example of the "mixed" views women have about their menses? That's just lame.]

Second, just because you don't want to suppress your period--women who wish to rely on their period as an indicator that they are not pregnant; women who view their period as a symbol of womanhood--doesn't mean you're ambivalent towards your menses. All it means is that you hold a different view than women who want to eliminate their periods. [Since we're on the subject, if you want to have monthly periods you are not a Pill candidate. You shouldn't use any Pill regimen--regular (21/7), extended-cycle (84/7), or continuous [336].]

Third, if you want to gain insight into what women think about Wyeth's Lybrel--a new pill that would eliminate the monthly withdrawal bleeding episode--you need to look at relevant data. Data on women who don't have an objection to suppressing their periods in the first place:

When women are allowed to choose their cycle length and duration of pill-free interval, they clearly prefer extended cycles and shorter pill-free periods. Among women who were permitted to set their own hormone-free intervals (n=220), most (60%) continued using extended cycles for more than 2 years, with 88% choosing a hormone-free interval of ≤4 days, with no serious sequelae or pregnancy.

The currently available medical research shows that the side effects of pills that suppress menstruation are the same as the side effects of regular birth control pills. The risks are generally low, but the most significant risk is cardiovascular problems in women who smoke, the reason that pills are packaged with a warning not to smoke.

Since pills that suppress menstruation and regular birth control pills are one and the same thing, what we learn from the NYT is that the side effects of the Pill are the same as the side effects of the Pill. Wow, that's powerful dude!

OK, one last time (in a different format for a change):

- Regular Birth Control Pills (x) and (y)
- Pills That Suppress Menstruation (x) and (y)/(z)
- Seasonale/Seasonique/Lybrel (x) and (z)

where x = suppression of menstrual period for duration of use
y = monthly withdrawal bleed
z = trimonthly/no withdrawal bleed

Now, it's quite possible that what the NYT reporter meant to say was that the currently available medical research shows that the side effects of pills that reduce the frequency of, or altogether suppress, the monthly withdrawal bleed are the same as the side effects of regular birth control pills. For example, this:

Since the early days of OC use, studies about reducing the number of pill-free periods have shown that it is a safe and effective option for many women....A recent study reexamined the extended 3-month cycle with a lower dose formulation (30 μg EE/150 μg levonorgestrel; Seasonale®, Barr Laboratories, Pomona, NY) in 682 women and found similar efficacy and safety to a 28-day cycle.

And this:

A recent review* evaluated the differences between cyclic (21-day) and continuous use (>28 days) of OCs. Due to the significant differences between published studies, the authors were unable to perform a meta-analysis; however, the authors concluded that the available evidence suggests that continuous use of OCs offers comparable contraceptive efficacy and safety to cyclic OC regimens. Bleeding patterns were either similar or improved with continuous OC use. Where evaluated, the incidence of cycle-related symptoms (such as headaches, tiredness and menstrual pain) was reduced with continuous OC regimens.

But some doctors caution that there is no data on what happens when menstruation is suppressed for a very long time.

"We don’t have any long-term studies for what happens if you stop periods for years and years and years," said Dr. Maria Bustillo, a reproductive endocrinologist in Miami. Dr. Bustillo said there was probably no increased risk over traditional birth control regimens, but added that the "jury is still out" on whether breast cancer risk might be increased.

Although studies are conflicting, some have shown that the birth control pill may increase that risk. According to the National Cancer Institute, research indicates that the pill increases the risk of liver cancer in otherwise low-risk women while decreasing the risk of cancers of the ovary and the endometrium — the lining of the uterus.

(my link)

We don’t have any long-term studies for what happens if you stop periods, other than all those studies that make the Pill--a drug which stop periods for years and years and years--one of the most studied medicines in history, right?

In any case, the point is that everything from the "jury is still out", studies are conflicting, to the lining of the uterus refers to the risks of the regular birth control Pill.

And just to be accurate, briefly:

Use of combined OCs is associated with a decreased risk of cancers of the endometrium and ovary and an increased risk of cancer of the cervix and liver, a small increased risk of breast cancer in young women and a decreased risk of colorectal cancer. However, there is great uncertainty regarding the causal link, if any, between combined OC use and liver and colorectal cancer, and recent evidence suggests no association between current or former combined OC use and breast cancer. Regardless, the net effect of pill use on cancer is negligible.

With Barr’s Seasonale and Seasonique, the biggest medical problem so far — one that has also cropped up in tests of Wyeth’s Lybrel — is that users can have unpredictable and irregular bleeding or "spotting" that is worse than with regular birth control pills. But for some women who view their periods as the natural order of things, the qualms go beyond purely medical concerns.

...

One [woman] who attended the screening [of Ms. Chesler’s documentary "Period: The End of Menstruation?"], Aviva Bergman, a 22-year-old student at Goucher College in Maryland, said she would not use products that suppressed her period because it seemed unnatural.

"I just feel that there’s a reason you’re getting it every month," she said.

First, unpredictable and irregular bleeding or spotting (breakthrough bleeding, or BTB) is common with both regular and extended/continuous Pill use. The good news is that BTB is a nuisance side effect. The bad news is that, when it cames to the regular Pill, it's a major reason women discontinue use. [There are ways to minimize BTB. If you experience BTB don't suffer in silence. Ask your Ob/Gyn for help.]

Second, with both extended and continuous use, BTB tends to be slightly worse during the first few months of use only.

Third, the problem of focusing on a non representative group when discussing women's views of extended/continuous Pill regimens crops up once again. Women who view their periods as the natural order of things are not Pill candidates, and should not be using this birth control method. You cannot tell how women view eliminating the monthly withdrawal bleed by looking at women who object to using the Pill in the first place.

Finally, regarding there’s a reason you’re getting your period every month. Indeed there is. Menstruation has a single biological purpose; to prepare the uterus for a pregnancy. That's it.

Bottom line: If you're a NYT reporter writing an article claiming that extended/continuous use Pill brands are getting a mixed review, you need to (a) insure that your medical facts are correct, (b) use correct facts consistently, throughout the article, and (c) back up your claim with relevant data and quotes from informed experts.

PS And if you're Wyeth and you want to insure solid sales for Lybrel, call me you need to make sure women have complete and correct information about the menstrual period, withdrawal bleeding, and the Pill's effect on these events.



[*Edelman AB, Gallo MF, Jensen JT, Nichols MD, Schulz KF, Grimes DA. Continuous or extended cycle vs. cyclic use of combined oral contraceptives for contraception. Cochrane Database Syst Rev. 2005;CD004695.]


(via Women's Health News)

The Demise of the Placebo Week

Instructive editorial by Dr. Sulak in support of altering the current 21/7-day (placebo week) Pill regimen:

Oral contraceptives are the most common method of reversible contraception, with the majority of women using them sometime during their reproductive life. Modifications have primarily involved lowering hormone content and utilizing new progestin components.

The 21/7-day OC regimen (21 days active/7 days hormone-free) was arbitrarily created to mimic the average spontaneous menstrual cycle of 28 days. After more than 40 years of use, the traditional 21/7-day OC regimen is undergoing necessary, overdue changes in design. Numerous studies over the last decade have documented that lowering the doses of hormones in OCs without altering the standard 7-day hormone-free interval (HFI) compromises suppression effects and can induce hormone withdrawal symptoms.

Although today's low-dose OCs are very effective in preventing pregnancy, studies have confirmed incomplete inhibition of pituitary-ovarian function with follicular growth and resultant endogenous hormone production and potential for follicular cysts and ovulation. With a standard 7-day HFI, follicle-stimulating hormone begins to increase on day 3–4 of the HFI, allowing follicular recruitment and estradiol production. While uncommon, pregnancy can occur because of this escape ovulation, even in perfect users. Low-dose OCs have also been shown to provide little to no protection from the development of functional ovarian cysts because of the 7-day HFI. Unfortunately, most of our patients do not take their pills perfectly, increasing the chance of ovarian cysts and pregnancy.

Today's standard low-dose 21/7-day OCs have also been responsible for the occurrence of nuisance side effects in many patients. Published data document an increased incidence of menstruation-related symptoms during the 7-day HFI in patients on standard 21/7-day low-dose OCs, with increases reported in headache, pelvic pain, bloating/swelling, breast tenderness, and use of pain medication during this placebo interval. Menstruation-related symptoms including headache, mood swings, abdominal cramping, bloating, and breast tenderness are long-recognized side effects associated with OCs and often lead to untimely discontinuation and resultant unintended pregnancy.

The question is not "Should the current 21/7-day OC be altered?" but instead "How is the 21/7-day OC to be altered?" Modifications are necessary to address the issues of increased symptomatology and follicular development. We need to set women up for success rather than failure.

Currently, several approaches alter the typical 21/7-day OC regimen. Shortening the 7-day hormone-free interval of today's low-dose OCs can provide greater pituitary-ovarian inhibition, reducing the risk of ovulation, ovarian cyst formation, and common hormone withdrawal symptoms. Two OC products that utilize 24 days of active hormones and a 4-day HFI (24/4) have been approved by the FDA in 2006: ethinyl estradiol 20 mcg/drospirenone 3 mg (Yaz, Berlex) and ethinyl estradiol 20 mcg/norethindrone acetate 1 mg (Loestrin 24 Fe, Warner Chilcott).

Extending the number of active pills beyond the standard 3 weeks to 6, 9, 12, or more weeks is also common practice. A recent survey of health care providers in the United States revealed that the majority thought extended regimens should be offered to women who desired elimination of monthly withdrawal bleeding and associated symptoms.

The first approved extended regimen became available in the United States in 2003 (Seasonale, Barr Laboratories), and consists of 84 days of 150 mcg of levonorgestrel and 30 mcg of ethinyl estradiol followed by a 7-day HFI. But, a 7-day HFI with an extended regimen can lead to the same problems seen with a 21/7-day regimen.

A new OC approved in May 2006 both extends combination active therapy to 84 days and adds low-dose estrogen to the usual 7-day HFI (ethinyl estradiol 30 mcg/levonorgestrel 150 mcg for 84 days plus ethinyl estradiol 10 mcg for 7 days; Seasonique, Barr Laboratories). By doing so, it becomes the first approved OC to completely eliminate the HFI. Addition of low-dose ethinyl estradiol during the HFI provides greater pituitary-ovarian suppression, preventing an increase in follicle-stimulating hormone, follicular development, and endogenous estradiol production.

Continuous OC regimens that entirely eliminate the HFI are being extensively studied. While these extended, continuous regimens decrease scheduled bleeding, they can cause irregular, nuisance bleeding or spotting. Breakthrough bleeding with continuous OCs has been shown to be effectively managed by institution of an abbreviated 3-day HFI.

As more modifications of the 21/7 regimen are approved, it is important to ascertain from each patient her desired menstrual frequency. As in the movie, we must find out “What Do Women Want?” Whether she wants to bleed once a month, once every 3 months, or never will determine what regimen we should recommend. Today, we can give women what they want and decrease side effects, increase compliance, and decrease unintended pregnancy. No matter what the menstrual frequency, the 7-day HFI needs to be eliminated.

Today's low-dose 21/7-day contraceptive regimens have documented design flaws that can result in discontinuation and unintended pregnancy. Modifications of the standard 21/7-day design seen in today's vaginal contraceptive ring, transdermal patch, and OCs can greatly improve the side effect profile and continuation rates. Shortening the HFI, adding estrogen to the standard HFI, and extending the active component are all effective improvements that provide greater ovarian suppression, and will eventually lead to the demise of low-dose 21/7-day regimens. The sooner, the better.

Generic Seasonale

I keep forgetting to post this: Seasonale is now available as a generic (less expensive).

Both Barr Labs and Watson Pharmaceuticals have a generic version (once again I must ask, who comes up with these product names?):

Barr Labs.....Jolessa

Watson....... Quasense

Jolessa (via)

Quasense (via)

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.

I Embrace Opinion Health Reporting

I don't have too much to say about this New York Observer article (via mousewords) on Seasonale because I'm new to entertainment-type health reports--heavy on opinion, light on facts and practical information. I don't find them very valuable. It's not so much that I don't enjoy reading the writer's opinions, or those of the women featured in the article. We all have opinions [I heard some people even maintain an on-line journal to express them]; they're good for our ego, and, on most occasions, an interesting read. I just think there's too much health education to be done, and misinformation to be corrected, to write a health article devoid of actual information.

In any case, I do have one comment, and a couple of corrections:

"They're very alluring ads," said Barbara Seaman, a veteran women's-health activist who lives on the Upper West Side--and she didn't mean that as a compliment. "Quite brilliant--an innocent young woman who has no idea about the dangers. It's just some sort of crazy male fantasy."

I'm surprised a women's-health activist would have such a patronizing attitude. Just because a woman is young she shouldn't be assumed to be a moron, a hapless innocent who views an ad from the big, bad wol...er pharma and without questioning or educating herself further, and devoid of the ability to grasp the concept of a drug's risks/benefits, starts using it.

Ms. Seaman also pointed to higher rates of "breakthrough bleeding"--unexpected periods--that the Seasonale ad acknowledges. "This whole thing is a joke," she said. "You're taking this so you don't bleed, but then you bleed more than people on the regular Pill!" (Seasonale literature claims this side effect tends to "decrease during later cycles.")

Breakthrough bleeding/spotting (BTB/S) is the occasional, irregular bleeding/spotting some women experience while using hormonal birth control (for pregnancy control or menstrual management). It is most common when you first start using a method, and it usually stops after the first 2-3 months of use. Whether you experience BTB/S will depend on the brand, method, and your body.

Think of BTB/S as an "adjustment" bleeding--the bleeding occurs because the body is adjusting to the hormone dosage in the birth control method. Practically, there are two important things you should remember about BTB/S: it causes no ill health effects, and it isn't a sign that something is wrong; it's just a nuisance. [An important one, however, since BTB is one of the main reasons women stop taking the Pill.]

Ms. Seaman's opinions aside, here are the data for Seasonale:

Median number of BTB/spotting days per 91-day cycle decreased from 12 days during cycle to 1 to 4 days during cycle four

Three fourths of BTB/spotting days were spotting only

[The full study article is not free, so I'm going to quote the entire relevant section, and bold the relevant data.]

Unscheduled (breakthrough) bleeding

Like all OC products, patients who received the extended cycle regimen reported varying degrees of breakthrough bleeding (BTB). The active treatment duration of each extended cycle was four times the length of the active treatment duration for each conventional cycle (84 days vs. 21 days). Within the extended cycle regimen treatment group, there were fewer days of BTB with each successive cycle from a median of 12 days during cycle 1 to a median of 4 days during cycle 4 (Fig. 3). The onset of BTB also occurred later within each successive extended cycle and was of shorter duration with each successive extended cycle. The median number of days of unscheduled bleeding-only days in each cycle, as well as the percentage of patients reporting unscheduled bleeding in each cycle, decreased throughout the course of the study as depicted in Fig. 1.

Extended cycle regimen patients initially reported slightly more breakthrough bleeding and/or spotting and bleeding-only than did patients treated with the conventional regimen. By the last extended cycle (cycle 4), breakthrough bleeding was comparable in the two treatment groups. Of the total number of possible days of unscheduled bleeding or spotting days that could be reported (active therapy days: 336 for the extended cycle regimen vs. 273 days for the conventional regimen), a median of 3.6% days on the extended cycle regimen and 2.9% days on the conventional regimen were associated with diary entries of unscheduled bleeding.

The majority of patients in both treatment groups reported ≤5 days of unscheduled bleeding per cycle. By the end of the study (cycle 4), 41.5% of extended cycle regimen patients reported no unscheduled bleeding and >80% had ≤5 days. The percentage of patients reporting higher numbers of unscheduled bleeding days (≥6) also decreased with each successive cycle of therapy.

The Observer article continues:

Dr. Susan Rako, a psychiatrist who authored the book No More Periods: The Risks of Menstrual Suppression, (Harmony, 2003), pointed to studies showing increased cervical-cancer rates for women on birth-control pills (the American Cancer Society's Web site calls this a "very slight potential risk"); the potential for testosterone deficiency, which lowers libido and general metabolic health; and the lack of longitudinal studies on Seasonale.

In the US, approximately 13,000 women develop cervical cancer and an estimated 4,100 women die from it each year. Cancer of the cervix is easily detectable--through Pap smear, human papilloma virus (HPV) typing, and colposcopy. This type of cancer develops slowly and is relatively easy to treat. The survival rate for the preinvasive stage (carcinoma-in-situ) is >95%; for the invasive stage it's 70% for white women (56% for black women) at the 5 year mark.

An aside: Sexual behavior--early age at first intercourse and high number of sexual partners--is the major risk factor for developing cervical cancer. Aim to minimize this risk, and use a barrier method consistently.

For most women, neither using the Pill nor having a monthly menstrual period increases or reduces the risk of cervical cancer. However, HPV, the virus that causes genital warts, is a factor when it comes to cervical cancer.

The majority of women who develop cervical cancer (94% of women with invasive cancer, and 72% of women with preinvasive cancer) also test positive for HPV.

In healthy women, there is no overall association between using the Pill and becoming HPV positive. In women infected with HPV, using the Pill for less than 5 years is not associated with an increased risk of cervical cancer. In HPV infected women who had used the Pill for 5 to 9 years, some studies suggest the risk of cervical cancer was increased. This doesn't mean the Pill causes cervical cancer [studies are under way to determine if there's a connection].

An aside: Good news on the HPV vaccine front:

[The] HPV 16 ... vaccine was 94% effective in preventing persistent HPV 16 infection and 100% effective against cervical intraepithelial neoplasia (CIN) grades 2 and 3, compared with placebo over 3.5 years. The study included 1,533 women aged 16-23 years who were initially negative for both HPV 16 DNA and antibodies.

...

No cases of HPV-related CIN occurred in any vaccine recipient. In contrast, among the placebo subjects, HPV 16-related CIN 1 was found in 12, CIN 2 in 7, and CIN 3 in 6 (one woman had CIN 2 at one visit and CIN 3 at another).

Back to the Observer article and Dr. Susan Rako [pointing to the] potential for testosterone deficiency, which lowers libido and general metabolic health; and the lack of longitudinal studies on Seasonale.

Here's the short version on what's wrong with the article's claims about testosterone (T): Women who use the Pill have a lower free T level than non-users. This doesn't mean they have a T deficiency. In women, a testosterone deficiency state has not yet been defined. Moreover, just because the T level is low, doesn't mean the sex drive (libido) is decreases. Can't comment on the "general metabolic health" because I have no idea what that means.

Here's the long version: Testosterone (a hormone) is produced by the ovaries and, in contrast to the other ovarian hormones (estrogen and progesterone), it's not involved in regulating the menstrual cycle. In women, testosterone (T) levels are much lower than in men. This makes it very difficult to measure women's T levels accurately [but new tests are being developed]. Only about 2% of the total circulating T is active; the rest is bound to a protein called sex hormone-binding globulin (SHBG). Some Pill brands increase the SHBG, which means more T will be bound and less hormone will be available.

An aside: By decreasing the amount of free T, Pill use is able to help women with acne, excessive hair growth (hirsutism), and polycystic ovarian syndrome (PCOS).

In men, T determines a man's secondary sexual characteristics (larger muscle mass, deeper voice, hair distribution pattern) and sex drive (libido)--a low T level means a low sex drive. In women, there's no such direct relationship between T levels and sex drive; many factors play a role. [I'm going to briefly quote from the post I linked to.]

We know that in men (and some postmenopausal women) low levels of androgens create a deficient state called hypoandrogenism, we know the problems associated with this state (e.g., low sex drive), and we know how to treat it (testosterone supplementation). However, in women it's not clear that such a low androgen state even exists.

This is what two actual experts in this field have to say about the possibility that a T deficiency state exists in women:

YES:

As research continues in this area, especially in the area of assays that accurately measure free T at low levels, our understanding of androgen insufficiency in woman will broaden.

NO:

In summary, FAI [Female Androgen Insensitivity syndrome] is poorly defined and characterized. There are no clear diagnostic criteria. Therapy with androgen has yet to be proved safe and effective.

Regarding T levels and libido, let me use a couple of studies to illustrate the point. A group of women whose sexual function was impaired (the women reported feeling less sexual excitement and also had lower T levels) was given T to raise its overall level. The increased hormone levels influenced the "mechanical" aspects of sexual function (blood rushed to the vagina), but the women reported no change in their sexual excitement. In other studies, some women who use the Pill reported increased sexual thoughts, whereas others reported that they had reduced sexual thoughts while on the Pill.

Finally, the issue with longitudinal studies is not clear. Briefly, with this type of study you want to look at an exposed group (e.g., women who use the Pill on the regular regimen and don't have monthly menstrual periods, or women who use the shot and don't have monthly fake periods) vs. a group without the exposure (women who don't use birth control), or at groups with different degrees of exposure (women who use the pill on a regular regimen and have monthly fake periods vs. women who use Seasonale and have trimonthly fake periods). We have decades of these types of studies (the first studies on the trimonthly period regimen are from the 1970s), and, of course, there are ongoing studies.

So, that's all I have to say about the article. But wait, there's more!

Because most women are exposed to this type of article [and because I had to run an errand], I decide to embrace opinion health reporting and give it a try. So I did my own unscientific [and terribly clustered, because it was raining and I didn't feel like walking around too long] sampling.

I went to one apothecary, Winsdor on 6th (chic place, no insurance accepted), and 3 Duane Reade stores (big chain). At Windsor they sell ~1-2 packs/mo, an expected sale volume for a relatively new product at that location, according to the pharmacist. At the small DR also on 6th Ave., they sell ~2 packs/week (8/mo), a medium volume in the pharmacist's estimate. At a newly opened, medium-sized DR on 57th St., the night pharmacist estimated a 2 packs/mo sales volume. Finally, at the large DR store on Broadway they sell ~5 packs/week (20/mo).

So, what does my sampling tell us about the desired effect [of Barr's advertising], at least among skeptical Manhattanites? Um, not much [and after I ruined my umbrella for you people]. We're missing so much data--control, sample size, etc.--we can't even make an educated guess.

In the end, it comes down to this. Defining women based on the state of their uterine lining, and infusing the menstrual period with all sorts of mystical attributes (the essence of femininity; the one thing that defines femininity) is detrimental to making informed health decisions.

The menstrual period is just a body function, and menstrual management is a tool at your disposal. You use period control if and when it benefits your lifestyle and/or health, not because periods are bad, or you should be ashamed of them.

Bottom line: There are a bunch of perplexed pharmacists in the city tonight. And when I mention at the start of a post that I don't have a lot to say about an article, take that with a grain of salt.

Accuracy in Media Health Reports

Errors in newspaper articles covering emergency contraception pills (ECPs) may have contributed to incorrect beliefs about this form of birth control, according to an abstract* presented at this year's Association of Reproductive Health Professionals (ARHP) conference.

The researchers found that, despite EC's potential to prevent unintended pregnancies and abortions--51,000 abortions deterred in 2000 alone--errors in newspaper articles about ECPs were prevalent, and persisted over time.

The study analyzed the content of 1077 articles in 113 newspapers, from 1992 to 2002, discussing both ECPs and medical abortions (MTP). Of all articles, 44.5% (n=479) included more than one instance of confusion between ECPs and one of the drugs used for MTP, mifepristone. Inaccurate portrayal of ECPs' mechanism of action as medical abortion was noted in 31.8% (n=343) of articles, and 13.1% (n=141) inappropriately applied terms such as "abortifacient post-coital contraceptives" for ECPs.

I haven't conducted a formal study, but while doing research for my book I most certainly noticed that the majority of articles about Seasonale and period control are inaccurate. They consistently get two basic facts wrong:

1. The real and the fake period are not one and the same.

Seasonale, or any comparable Pill regimen for that matter, doesn't reduce the number of yearly periods from 13 to four.

Women using the Pill don't have menstrual periods. Extended-, or continuous-use Pill regimens only shift the frequency of the fake period (withdrawal bleeding) from 13 to four.

2. There are over 30 years worth of studies on the safety of menstrual suppression.

Menstrual suppression isn't a new, experimental thing, and there is an abundance of long-term studies on the side effects of suppressing the period.

Tens of millions of women have been using the Pill, and thus suppressing their menstrual periods, since the 1960s. According to the FDA, over the years, more studies have been done on the pill to look for serious side effects than have been done on any other medicine in history.

Because skipping a real period has a different risk/benefit profile than skipping a fake period [I'll do a separate post on this topic], these entrenched errors negatively affect your ability to make an informed decision about menstrual management.

Between the errors found by the study on EC newspaper articles, the mountain of misinformation about menstrual menstrual management, and the factually challenged major media reports about the Ortho Evra skin patch, I think we have a candidate for Jeff Jarvis' new mediawatch segment about stories that receive too little [try none] coverage: Prevalent, and persistent errors in media health reports.


*Pruitt S, Dolan Mullen P. Contraception or Abortion? Inaccurate Descriptions of Emergency Contraception in Newspaper Articles, 1992-2002. Contraception. 2004;70(3):259-60.

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.)