Lybrel: New safe,effective year-round contraceptive

WASHINGTON: 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 US 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 journal 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 David F Archer, a professor of obstetrics and gynecology at Eastern Virginia Medical School.

The downside is that some women who use this Contraceptive pill Lybrel will have some bleeding or spotting, Archer said. "You get rid of the anticipated menstrual period, but you replace it with 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% of the women taking the pill Lybrel 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% of the women of the 8% who quit the study of the contraceptive pill Lybrel, he noted.

Another benefit to Lybrel 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% of the women reported an absence of bleeding. Moreover, 58.7% of the women reported having no menstrual cycles.

In addition, only about one woman out of a hundred will become pregnant while taking the Contraceptive pill, Archer said.

One expert says that because of the incidences of bleeding, this contraceptive 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 Philip D Darney, chief of Obstetrics, Gynecology and Reproductive Sciences at San Francisco General Hospital.