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Low-Dose Birth Control Pill Cyclessa (Desogestrel/Ethinyl Estradiol) Now Available in US

WEST ORANGE, NJ -- June 13, 2001 -- Organon Inc. today announced the consumer launch of Cyclessa™ (desogestrel/ethinyl estradiol), its new low-hormone-dose oral contraceptive.

Recently approved by the Food and Drug Administration (FDA), Cyclessa has just 25 micrograms of estrogen (ethinyl estradiol), making it the lowest estrogen dose triphasic birth control pill approved by the FDA and available across the U.S. Most commonly prescribed low-dose oral contraceptives have daily estrogen levels of 30-35 micrograms. Even with its significantly reduced estrogen dose, Cyclessa allows women to maintain excellent cycle control and benefit from the reliability associated with oral contraceptives.

Cyclessa is designed to significantly reduce women's overall hormonal exposure while maintaining contraceptive efficacy. Cyclessa consists of 25 mcg of estrogen per day for 21 days. The daily progestin dose is 100 mcg of desogestrel for days 1-7 of the cycle pack and is increased from 125 mcg to 150 mcg for days 8-14, and 15-21 respectively. The last week of the cycle contains placebo pills.

"The oral contraceptive trend on declining estrogen doses may be associated with unpredictable bleeding, however, Cyclessa represents a low dose triphasic oral contraceptive pill with excellent cycle control and very little breakthrough bleeding," said Dr. Andrew M. Kaunitz, lead clinical investigator, Department of Obstetrics and Gynecology, University of Florida Health Sciences Center in Jacksonville, Florida.

Cyclessa is an excellent triphasic oral contraceptive choice for all women, including first time users and women switching from another pill. In clinical trials, Cyclessa users reported less break-through bleeding and spotting than women who were using a higher estrogen dose triphasic oral contraceptive.

Organon is committed to providing women with a variety of unique and innovative contraceptive options to effectively meet their birth control needs. Cyclessa joins Mircette® and Desogen® in Organon's oral contraceptive product line.

"We are pleased to expand our contraceptive portfolio by providing the first low estrogen dose triphasic birth control option for women in the U.S.," said Dr. Hans Vemer, President, Organon Inc.

Cyclessa does not protect against HIV infection and other sexually transmitted diseases. Cigarette smoking increases the risk of serious cardiovascular side effects. Women who take oral contraceptives are strongly advised not to smoke, and the use of oral contraceptives is associated with increased risks of several serious side effects including myocardial infarction.

SOURCE: Organon Inc.

Related Link: Organon Inc..

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