Seasonal Approach to Birth Control?

Imagine having only 4 periods each year, instead of the traditional 13. With Seasonale, a new oral contraceptive pill, women can do just that. In early September, the U.S. Food and Drug Administration granted approval for Seasonale, manufactured by Barr Laboratories, Pomona, New York.

The idea of menstrual suppression is not new and the reasons for seeking it vary. For some women, it is means of managing the debilitating symptoms that can occur with menstruation. For others, it is a matter of minimizing the frequency of an inconvenient monthly occurrence. On a wedding day, honeymoon, or family vacation, for example, no woman wants to have the added burden of menstruation. Many women—on their own or at the recommendation of a physician—have selectively used oral contraceptives (birth control pills) to suppress menstruation for certain occasions.

Clinicians also prescribe oral contraceptives for women who have conditions such as mild endometriosis (abnormal growth of uterine tissue that can cause abdominal pain and menstrual irregularities); premenstrual syndrome, or, PMS (causes irritability, emotional instability, depression, headache and other aches and pains); or painful, heavy, or lengthy menstruation. Taking oral contraceptives can help reduce the severity of symptoms caused by these condition and reduce menstrual frequency.

Repackaged suppression
Seasonale, simply put, is a re-packaged version of menstrual suppression. Seasonale contains the same hormones as traditional oral contraceptive pills, with a combination of ethinyl estradiol (estrogen) and levonorgestrel (progestin). What’s different is the way in which Seasonale is taken.

The traditional oral contraceptive dosing regimen involves taking the active drug for 21 consecutive days and then taking a placebo, or sugar pill for 7 consecutive days thereafter. The "placebo" phase, during which no active drug is ingested, is designed to allow menstruation to occur. With Seasonale, however, women take the active pills for 84 consecutive days, followed by seven consecutive placebo days.

This dosing schedule reduces menstrual frequency to four cycles per year, instead of the usual 13, says Kristina Sole, MD, associate staff member, Cleveland Clinic Department of Obstetrics and Gynecology. "Instead of having the fourth week as a placebo week, the dosing continues for 11 straight weeks before allowing for 1 week of withdrawal bleed."

Addressing some concerns
But what about the effectiveness and safety of suppressing menstruation with Seasonale? According to Dr. Sole, clinical trials have shown that Seasonale is as safe and effective in preventing pregnancy as traditional oral contraceptives. The FDA based its approval on results from a clinical trial involving 1,400 women aged 18 to 40 who used Seasonale. Researchers from the Eastern Virginia Medical School, where the study was conducted, concluded that Seasonale was similar in safety and efficacy to traditional oral contraceptives.

Dr. Sole also said the risks associated with taking Seasonale are no different than those associated with use of traditional oral contraceptives. These include a small increase in risk of stroke and blood clots. Because the drug is new, however, no data are available regarding the possible long-term effects of using Seasonale, says Dr. Sole. So women may want to wait a year or two before experimenting with it.

For women concerned that reducing menstruation from 13 to 4 cycles per year might somehow make those periods that much more trying, Dr. Sole says that based on what is already known about use of oral contraceptives, such a scenario is unlikely. For instance, women who have used continuous oral contraception for menstrual suppression to manage medical conditions such as mild endometriosis, in general, do not experience worsened menstrual symptoms, she says.

Women also might be concerned about the ability to conceive after using Seasonale, but Dr. Sole says there is really no basis for such worry. "My guess is that it won’t make any more difference than it would for someone who is on traditional oral contraceptives. Most women who stop using those start to ovulate again fairly soon." She also says that menstrual suppression for medical reasons does not affect fertility and that when such therapy ceases, normal menstruation—and the ability to conceive—is restored fairly rapidly. "I can’t imagine that fertility issues will be much different for women taking Seasonale compared with those taking traditional oral contraception," says Dr. Sole. She said that in either case, ovulation will recur usually within the first three months of stopping oral contraception

One possible disadvantage associated with use of the new drug may be breakthrough bleeding, due to the moderately low dose (30 micrograms) of estrogen in Seasonale. Breatkthrough bleeding is spontaneous or "unscheduled" bleeding or spotting that occurs outside the time frame of the a woman’s normal menstrual cycle. Traditional oral contraceptives use anywhere from 20 to 35 micrograms per dose; the lower the dose of estrogen, the higher the rate of breakthrough bleeding. Seasonale’s manufacturer reports breakthrough bleeding rates similar to those that would occur with one-month’s use of a 30 microgram oral contraceptive, says Dr. Sole. But that potential for breakthrough bleeding during prolonged menstrual suppression could be an issue for some women, she says. She also said that for women taking oral contraceptives who need a 35- rather than a 30-microgram estrogen dose to curb breakthrough bleeding, Seasonale will not be an option.

"Seasonale is just another birth control option," says Dr. Sole. Albeit for many women, possibly an appealing one. Women who are curious about the drug should discuss the issue with their physicians, she advises, so they can learn more about it and whether or not they are candidates. For instance, women over age 35 who smoke should not take traditional oral contraceptives, nor should they take Seasonale. Other factors that preclude use of oral contraception, says Dr. Sole, include personal history of breast cancer, undiagnosed abnormal uterine bleeding, liver disease, a history of blood clots or clotting disorders and uncontrolled high blood pressure.

Visit the following web site for more information: U.S. Food and Drug Administration Office of Women’s Health http://www.fda.gov/womens/default.htm