Wyeth presents new abstracts for daily oral contraceptive Lybrel

By Elaine Rigoli

Tampa, Fla., May 8 - Wyeth Pharmaceuticals released two scientific abstracts relating to the investigational, combination oral contraceptive Lybrel (90 mcg levonorgestrel/20 mcg ethinyl estradiol tablets) at the American College of Obstetricians and Gynecologists annual clinical meeting in Washington, D.C.

The first scientific abstract reported on the return to menstruation after stopping Lybrel. The study showed that 99% of 187 participants experienced either a return to menses or became pregnant within 90 days after stopping the study drug, the company said in a news release.

In the scientific abstract presenting the safety and efficacy profile of Lybrel compared with a traditional 21-day cyclic oral contraceptive in European women, the investigators reported that the oral contraceptive prevented pregnancies in all of the 323 women who took Lybrel; three of the 318 participants who took the traditional 21-day cyclic oral contraceptive became pregnant.

The New Drug Application for Lybrel is under review by the Food and Drug Administration. If approved, Lybrel would be the first combination oral contraceptive taken 365 days a year without a placebo phase or pill-free interval, the release said.

Madison, N.J.-based Wyeth Pharmaceuticals develops products in the areas of women's health care, cardiovascular disease, central nervous system, inflammation, transplantation, hemophilia, oncology, vaccines and nutritional products.

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