Mircette, Low-Dose Oral Contraceptive, Available In U.S.
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Mircette, Low-Dose Oral Contraceptive, Available In U.S.

WEST ORANGE, NJ -- July 24, 1998 -- Organon Inc. announced today the United States-wide availability of Mircette(TM) (desogesterel/ethinyl estradiol and ethinyl estradiol) Tablets, approved by the U.S. Food and Drug Administration on April 22, 1998.

The Mircette oral contraceptive regimen reduces the daily estrogen dose from the commonly prescribed 30 to 35 mcg level while maintaining cycle control and a favourable tolerability profile.

Mircette has a novel dosage regimen 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. The clinical significance of a reduced hormone-free interval has not been established.

"This is good news for millions of women and their care givers who want new options for birth control," said Sarah Berga, MD, associate professor of OB/GYN, division of reproductive endocrinology, The University of Pittsburgh School of Medicine. "A new oral contraceptive like Mircette is a welcome addition to the oral contraceptives now available. Clinical studies of this new drug indicate effective and well tolerated contraception for new patients, patients who change therapy, perimenopausal and postpartum women."

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