The first birth control pill designed to completely eliminate periods for one year is also proving to be an effective treatment for premenstrual syndrome (PMS).
The experimental low-dose combined contraceptive, which delivers estrogen and a progestin 365 days a year (with no pill-free interval), was found to be highly effective in stopping monthly periods and alleviating the emotional and physical symptoms linked to menstruation.
The new study released Monday was one of four evaluating the birth control pill Lybrel presented at the 61st annual meeting of the American Society for Reproductive Medicine in Montreal.
The research was funded by drug maker Wyeth Pharmaceuticals, which is seeking FDA approval for the continuous-use contraceptive pill. Wyeth is a WebMD sponsor.
More Women Skipping Periods
Women seeking contraception have had increasing power over the timing of their periods in recent years. The injectable hormonal contraception Depo-Provera can suppress monthly periods, although irregular breakthrough bleeding can occur in many users.
And the approval of the Seasonale birth control pill two years ago ushered in the era of seasonal menstruation. Women on this birth control pill menstruate just four times a year.
Oral contraceptive users who have PMS, troublesome periods, or painful endometriosis are also increasingly skipping the seven-day pill-free interval (placebo or sugar pills at the end of the pack) recommended with currently approved birth control pills. Instead, they are opting, with their doctor’s knowledge, to take active-hormone pills continuously to eliminate monthly menstruation.
“It is not uncommon for women and their [physicians] to choose to monitor when they have their menstrual cycles or to eliminate them completely,” University of Vermont professor of obstetrics and gynecology Julia Johnson, MD, said at a news conference from the Montreal meeting.
PMS Symptoms Improved
In the studies, the continuous-use pill was found to be as effective for preventing ovulation and pregnancy as the oral contraceptives that are now on the market.
While breakthrough bleeding did occur in about a third of women, this became less frequent the longer the women stayed on the pill.
In a study involving roughly 100 women with PMS or similar menstrual-cycle-related symptoms, most women reported significant improvement in mood, behavior, and pain within a month of starting the continuous oral contraception regimen.
Women who suffered from menstrual cramps also reported improvement. Within three months of starting the continuous-hormone pill, cramps were reduced by 85%.
“It appears that this low-dose, continuous-use oral contraceptive significantly improves cycle-related symptoms,” says researcher and University of Pennsylvania ob-gyn professor Ellen Freeman, MD.
No Need to Bleed
A new drug application for the no-period birth control pill was submitted to the FDA in July. Wyeth spokeswoman Amy Marren, MD, says the pharmaceutical company is hoping for FDA approval by next spring.
Obstetrics and gynecology professor David Grimes, MD, tells WebMD that there is no medical justification for the 21 days on hormones, seven-days-off regimens that have been used since birth control pills were first developed in the 1950s.
“This regimen simulates a normal menstrual cycle and can assure a woman that she isn’t pregnant, but other than that there has never been a compelling reason for it,” he says.
Grimes did not participate in the newly published studies. He is with the University of North Carolina and is vice president of biomedical affairs for Family Health International Research in Research Triangle Park, N.C.
“Some women like to bleed as an affirmation of their femininity, and that is fine,” he says. “But I think women seeking contraception are now beginning to understand that they don’t need to bleed.”The Future of Birth Control
SOURCES: American Society for Reproductive Medicine 61st annual meeting, Montreal. Ellen Freeman, PhD, research professor, department of obstetrics and gynecology, University of Pennsylvania School of Medicine. Susan Ballagh, MD, associate professor of obstetrics and gynecology, Eastern Virginia Medical School. Julia Johnson, MD, professor, obstetrics and gynecology; director, division of reproductive endocrinology and infertility, University of Vermont College of Medicine, Burlington. David Grimes, MD, vice president of biomedical affairs, Family Health International Research, Research Triangle Park, N.C.; professor of obstetrics and gynecology, University of North Carolina, Chapel Hill.