New Year-Round Contraceptive Pill Safe and Effective
Unpredictable bleeding did affect some women taking pill in the study
WEDNESDAY, Dec. 13, 2006 (HealthDay News) -- A new year-round contraceptive pill called Lybrel, which eliminates menstrual cycles altogether, appears to be safe and effective, researchers report.
Lybrel is not yet approved by the U.S. Food and Drug Administration, but a decision is expected next year. Currently, there are contraceptives available that reduce the number of menstrual periods to four a year, but this is the first study that shows it is safe to eliminate menstrual periods.
The report is published in the December issue of Contraception.
"One advantage to using this pill is that you take one pill regularly with the expectation that you are not going to have a regular menstrual bleeding period," said lead researcher Dr. David F. Archer, a professor of obstetrics and gynecology at Eastern Virginia Medical School.
The downside is that some women who use this pill will have some bleeding or spotting, Archer said. "You get rid of the anticipated menstrual period, but you replace it with some erratic, unpredictable bleeding or spotting," he said. "So, this is a group of women who are going to be willing to put up with that type of nuisance bleeding."
This unpredictable bleeding and/or spotting affects about 20 percent of the women taking the pill after a year, and it can last up to six days, Archer said. "It's impossible to predict which women will have bleeding and spotting," he added. However, it is the main reason that 18.5 percent of the women of the 8 percent who quit the study quit, he noted.
Another benefit to this pill is the elimination of menstrual cycle-related symptoms, such as mood changes, menstrual cramps and headaches, Archer said.
In the study, which was conducted at 92 sites in North America, Archer's group used a birth-control pill consisting of 20 micrograms of ethinyl estradiol and 90 micrograms of levonorgestrel. The pill was developed by Wyeth Pharmaceuticals.
The researchers gave the pill to 2,134 sexually active women, aged 18 to 49. The women took a pill daily without any breaks.
During the 18 months of the study, the number of days of bleeding decreased progressively. After one year, 79 percent of the women reported an absence of bleeding. Moreover, 58.7 percent of the women reported having no menstrual cycles.
In addition, only about one woman out of a hundred will become pregnant while taking the pill, Archer said.
One expert says that because of the incidences of bleeding, this pill isn't for every woman.
"The main advantage is that this continuous pill provides a lower dose than other continuous oral contraceptive pills like, Seasonale," said Dr. Philip D. Darney, chief of Obstetrics, Gynecology and Reproductive Sciences at San Francisco General Hospital and the University of California, San Francisco.
"Women who want to avoid menses and take a pill continuously, which for some women may provide greater efficacy and fewer side effects, will be able to use an 'ultra low-dose' pill, which may have some advantages for rare adverse effects of oral contraceptives, like thrombosis," Archer said. "Still, the main reason for stopping this pill was bleeding disruptions, so, it won't suit all pill users."
Another expert is concerned with the high number of women who continued to experience bleeding while taking the pill.
"I think continuous contraception is a great idea," said Dr. Camelia Davtyan, an assistant professor of medicine at the University of California, Los Angeles. "Nevertheless, the rate of uterine bleeding-related complications is quite high."
Davtyan thinks that to really test its efficacy, this new pill should be tested against the standard birth-control pill in a clinical trial. In addition, she said she is concerned that nothing is known about any side effects from the long-term use of this pill.
The U.S. Food and Drug Administration can tell you more about birth control.