Lybrel

Lybrel is an effective birth control pill and it is the first FDA approved oral contraceptive drug for prevention of pregnancy in women. Lybrel is developed by Wyeth Pharmaceuticals - it is the first and only low dose combination contraceptive pill that can be taken 365 days a year, without a placebo phase or pill-free interval. It is intended for women who are seeking contraception and who are interested in putting their menstrual cycle on hold. Lybrel provides a steady low dose of hormones so that over time women may become cycle-free. Women considering Lybrel should know that most subjects in the clinical studies experienced some breakthrough bleeding and spotting, especially during the first three to six months.

Lybrel is the only, birth control pill that is also designed to eliminate women's monthly periods. It comes in a 28-day pack of tablets containing 20 micrograms of ethinyl estradiol (an estrogen) and 90 mcg of levonorgestrel (a progestin). This is about equal to the lowest level of hormones in combination Oral Contraceptives today. Women who use Lybrel don't have regular periods, although they can have light bleeding. The FDA's Web site, fda.gov, says women taking Lybrel may experience spontaneous breakthrough bleeding.

Clinical trials have shown good results. Worldwide clinical trials involving 2,457 women demonstrated the efficacy of Lybrel. Lybrel had better or same contraceptive efficacy similar to other FDA-approved oral contraceptives. Breakthrough bleeding and spotting were also evaluated and were shown to lessen over time. The bleeding pattern was categorized in clinical trials as breakthrough bleeding that requires sanitary protection or spotting that did not require sanitary protection. There were 860 women who met criteria for evaluation and completed pill pack 13. During pill pack 13 (28-day interval):

The Lybrel safety and efficacy study was published in the December 2006 issue of the journal Contraception.