The new birth control pill reduces the number of menstrual periods to only four per year–hence the name, Seasonale.
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Women now have access to a wider variety of choices for reversible contraception than at any time in history. The most recent entry –an extended cycle contraceptive pill–allows a woman to radically alter her monthly menstrual cycle. But many women understandably have questions as well as reservations about such a dramatic change in managing birth control.
Recently approved by the Food and Drug Administration and sold under the trade name Seasonale, the new birth control pill uses a dosing schedule that reduces the number of menstrual cycles from approximately 13 per year to only 4, or one every season. Hence, the name.
Women taking Seasonale follow a 91 day cycle, taking an active pill for 84 days in a row, followed by an inactive pill for 7 days to complete the cycle. Bleeding occurs when the inactive pills are taken. The estrogen and progestin doses in Seasonale are comparable to those in the standard 28-day contraceptive pill cycle. So it’s not a new drug, just a new way of using an old drug.
An initial gut reaction many women may have is that the extended-cycle pill creates an unnatural environment by cutting the number of menstrual periods by two thirds. It’s true that this new regimen is far removed from the natural 28-day cycle, but the cycle women experience on traditional birth control pills is not a “natural” cycle. It’s 28 days long because when birth control pills were introduced the makers chose to mimic the natural cycle, in part to make the pill more politically and socially acceptable.
The idea of using contraceptive pills to create extended cycles is not new. Many physicians have used traditional contraceptive pills off-label to manipulate menstrual cycles either for convenience, for a special occasion, but more often to treat disorders such as acne, premenstrual syndrome (PMS) and endometriosis.
A study of 682 women assigned to take either Seasonale or traditional oral contraceptives for one year found the most notable difference in the two groups was that women taking Seasonale experienced more days of breakthrough bleeding (in the form of unexpected bleeding or spotting) than women taking traditional birth control pills: 12 days for the Seasonale group in the first cycle that decreased to 4 days by the fourth cycle. More women taking Seasonale withdrew from the study because of unscheduled bleeding, 7.7 percent compared with 1.8 percent for the traditional pill group.
A number of women taking Seasonale stopped having any menstrual bleeding as the study progressed. Although researchers say this is not harmful, women who fail to bleed when the inactive pills are taken may need to consider pregnancy testing.
The chances of unintended pregnancy while taking Seasonale are comparable to the chance of becoming pregnant on traditional birth control pills. With perfect use, the failure rate is about one percent (that means one in every 100 women taking the pill for one year will become pregnant). Traditional birth control pills have a failure rate of approximately five percent in real-world applications where pills are sometimes forgotten and not always made up according to package instructions. Large, long-term studies will be needed to evaluate real-world results from Seasonale, although it’s probable the results will be comparable to traditional birth control pills.
Which women will choose to use Seasonale? Will women decide to use Seasonale for convenience, taking advantage of the fact that medicine has given them the option of controlling menstrual bleeding? The makers of Seasonale have been cautioned by women’s advocacy groups that marketing of this new option might rely on creating a negative image of menstruation and of a woman’s normal biological cycle. They cite the importance, especially for teens and young women, of having a healthy self-image and positive sexual identity.
Women likely to try Seasonale include those with hormone-sensitive medical conditions, such as acne, heavy menstrual bleeding, severe menstrual pain, PMS, endometriosis and migraine.
Any woman considering the extended cycle contraceptive should discuss the advantages and disadvantages with her physician, especially related to her specific medical history. Some physicians are embracing this new option with enthusiasm, others are more cautious, suggesting their patients wait until it has been tested by larger groups of women.
Side effects of OCs
Unexpected bleeding, also called breakthrough bleeding, that occurs between monthly periods is the most frequent reason women give for stopping the standard 28-day cycle oral contraceptive pill. Other common side effects of the pill include nausea, weight gain, mood changes, breast tenderness and headaches.
Unwanted side effects prompt 32 percent of women who begin using oral contraceptives to stop within the first six months.
It’s not yet clear how well women will accept the new extended-cycle contraceptive pill. Tests showed high levels of breakthrough bleeding in the early cycles that led to high dropout rates, although unexpected bleeding diminished with longer use. Other side effects seen with the shorter cycle pill will also occur with the extended cycle version.
[SOURCE: Richard Legro, “A Review of Extended-Cycle Contraception,” Contraceptive Technology Update, November 2003]
Modern Women
Have More Periods
Today’s women have up to three times more menstrual periods than their great grandmothers. Reasons include: earlier onset of menstruation, access to contraception that leads to delayed childbearing and fewer children and less time spent breastfeeding.
Women today average 450 lifetime menstrual periods compared with fewer than 160 for women in the past.
[SOURCE: “Should Your Patient Be On Extended Cycle OCs?” Contemporary OB/GYNm September 2003]
Obesity and Risk Of
Contraceptive Failure
More than 10 million American women use oral contraceptives to prevent unwanted pregnancy. There are more than half a million unintended pregnancies every year among pill users, some as a result of missed pills but others apparently the result of having a higher body weight.
A study of 755 women enrolled in an HMO looked at the relationship between oral contraceptive failure and body weight.
Researchers found that women who weighed 155 pounds or more had a 60 percent increased risk of oral contraceptive failure compared with women of lower body weight. The risk was even greater for women using very low-dose oral contraceptives.
The authors suggested that physicians consider a patient’s body weight when choosing the optimum estrogen dose in an oral contraceptive.
[SOURCE: Anne Walling, “Obesity Increases Risk of Contraceptive Failure,” American Family Physician, September 1, 2002]
OCs Used to Treat
Menstrual Disorders
Oral contraceptives are commonly used off-label to treat menstrual disorders such as irregular cycles, painful menstrual periods and heavy bleeding. The pills help establish a regular cycle and keep bleeding under control.
One study of women using oral contraceptives to control heavy bleeding found that after three months of treatment with a combined oral contraceptive, the volume of blood lost was cut almost in half.
[SOURCE: Patricia J. Sulak, “Should Your Patient Be On Extended Use OCs?” Contemporary OB/GYN]
OCs and Health Risks
Studies comparing the new extended cycle oral contraceptive with the standard 28-day cycle pill found that both are associated with a small increased risk of stroke, blood clots and heart attack. For women with high blood pressure, the risk of stroke is 50 percent higher in those who take oral contraceptives.
For both types of contraceptive the risk was higher in women who smoke, especially those over age 35.
[SOURCE: “Applause– and Reservations–for Newly Approved Version of the Pill,” The Network News, Nov-Dec 2003]
Perfect Use Increases
Effectiveness of Pill
Oral contraceptives are highly effective when women remember to take them every day without fail. Missed pills, which are part of reality for the typical user, translate into a higher rate of unintended pregnancy. For every 1000 women who never miss taking a pill over a year, only one will become pregnant. For every 1000 women who represent typical users, however, 50 pregnancies will occur over a year.
[SOURCE: Sylvia Cerel-Suhl and Bryan Yeager, “Update on Oral Contraceptive Pills, “ American Family Physician,” November 1, 1999]
REFERENCES:
“Applause–and Reservations–for Newly Approved Version of the Pill,” The Network News, Nov-Dec, 2003.
Doug Brunk, “Extended Use OCs Pose ‘Educational Challenge,’; Warn About Breakthrough Bleeding,” Family Practice News, October 15, 2003.
Sylvia Cerel-Suhl and Bryan Yeager, “Update on Oral Contraceptive Pills,” American Family Physician, November 1, 1999.
“FDA Approves Birth Control Pill that Reduces Menstrual Frequency,” Drug Week, September 26, 2003.
Robert Hatcher, “A New Season,” Costraceptive Technology Update, July 2003.
“Interest in Extended-Use Contraception to Grow,” Contraceptive Technology Update, November 2003.
Jill Lambert and Warren Newton, “Continuous Use of Oral Contraceptives Reduces Bleeding,” Journal of Family Practice, August 2003.
Richard S. Legro, “A Review of Extended-Cycle Contraception,” Contraceptive Technology Update, November 2003.
Doreen Mangan, “New Oral Contraceptive Means Fewer Menstrual Periods,” RN, December 2003.
Patricia Sulak, “Should Your Patient Be On Extended-Use OCs?” Contemporary OB/GYN, September 2003.
Catriona Sutherland, “Contraception,” Practice Nurse, October 10, 2003.
Anne Walling, “Obesity Increases Risk of Oral Contraceptive Failure,” American Family Physician, September 1, 2002.
