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The First No Periods Contraceptive Is Approved

May 22, 2007

- Wyeth Pharmaceuticals –

“Constant pregnancy protection” and “no more menstrual periods” – these are the key statements about the first oral contraceptive for women, Lybrel, which can be used continuously without placebo or pills-free interval. The new contraceptive option was approved by the U.S. Food and Drug Administration on May 22, 2007. Lybrel is produced by Wyeth Pharmaceuticals, a company that investigates, develops and manufactures medical products in the area of women’s health care, infectious diseases, gastrointestinal health, central nervous system, inflammation, hemophilia and oncology.

Lybrel is the first and only prescription oral contraceptive that can be taken by women 365 days a year without a placebo interval, during which menstruation occurs. Thus, Lybrel is the first daily pill, which can offer women “no menstrual periods” lifestyle. According to Dr. Ginger Constantine, Vice President of Women’s Health Care in Wyeth Pharmaceuticals, Lybrel is for those women who seek contraceptive options and who are interested in putting their period on hold.

Lybrel is produced in the form of tablets for oral administration. Each pill contains 90 mcg of levonorgestrel and 20 mcg of ethinyl estradiol. These are the same hormones, used in other birth control pills, but the difference is that Lybrel offers lower concentration of hormones in each pill.

The new contraceptive has similar mode of action with other commonly used daily pills. The hormones, released by the medications, prevent ovulation or the release of an egg from female ovary, change cervical mucus so that spermatozoids cannot reach the egg, if released, and fertilize it.

The regimen of taking Lybrel is a bit different in comparison to traditional daily pills. Ordinary pills are usually taken for 3 weeks and than a woman should take placebo pills with no hormones, so that menstruation could occur. Then the cycle is repeated. With Lybrel there is no such placebo or hormones-free period. The pills are taken daily for the whole period of time when a woman wants to remain protected. The typical monthly menses do not occur with this type of regimen.

However, the FDA and Lybrel producer note that the unplanned breakthrough bleeding and spotting may occur while taking the pills, especially during the first 3-6 months of use. Clinical study showed that 20% of women taking Lybrel had spotting only, which did not require any sanitary protection, 21% experienced breakthrough bleeding and 59% did not experience any of those symptoms.

The FDA also said in its press-release, that women, using Lybrel for pregnancy protection, may experience certain difficulty with recognizing if they have become pregnant. The occurrence of menstruation every month is usually used as one of the signs of not becoming pregnant. However, with Lybrel there are no menstruations at all, so a woman is encouraged to use pregnancy test in case of any suspicions of becoming pregnant.

Finally, it should be noted that Lybrel is expected in the U.S. pharmacies as soon as July, 2007.

Nick

External resources
http://www.wyeth.com/news?nav=display&navTo=/wyeth_html/home/news/pressreleas...
http://www.medicalnewstoday.com/healthnews.php?newsid=71800
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01637.html