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| |  Oral Contraceptive, Mircette, Receives FDA Approval WEST ORANGE, NJ -- April 23, 1998 -- The United States Food and Drug Administration has granted marketing approval to Organon Inc.’s Mircette(TM) (desogestrel/ethinyl estradiol and ethinyl estradiol) Tablets, the first oral contraceptive to use a shortened hormone-free interval. The Mircette regimen reduces the daily estrogen dose from the commonly prescribed 30-35 mcg level to the 20 mcg level, while maintaining cycle control and a favourable tolerability profile. Mircette's uniqueness is based on the patented shortened hormone-free interval. The dosing begins with 21 days of 20 mcg ethinyl estradiol and 150 mcg desogestrel. The last seven days in the Mircette cycle start with two days of placebo pills, followed by five days of 10 mcg ethinyl estradiol pills. In contrast, all other combined oral contraceptives currently available in the U.S. have an initial three-week estrogen/progestin cycle, followed by the traditional one week of placebo pills. Doctors have prescribed supplemental estrogen during an oral contraceptive's seven-day hormone-free interval to women experiencing menstrual migraines and other inter-menstrual side effects such as dysmenorrhea and pre-menstrual syndrome. "This is good news for millions of women and their care givers who want new options for birth control," said Dr. Sarah Berga, associate professor of OB/GYN, division of reproductive endocrinology, The University of Pittsburgh School of Medicine. "An oral contraceptive with a low daily dose of estrogen and a shortened hormone-free interval is a welcome addition to the oral contraceptives available. "Clinical studies of this new drug regimen indicate effective and well tolerated contraception for new patients, patients who change therapy, perimenopausal and postpartum women." More information on: Organon Inc..
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