Organon Inc. today announced the consumer launch of Cyclessa(TM)
(desogestrel/ethinyl estradiol), its new low hormone dose oral
contraceptive. Recently approved by the Food and Drug
Administration, Cyclessa (TM) 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 it's significantly
reduced estrogen dose, Cyclessa(TM) allows women to maintain
excellent cycle control and benefit from the reliability associated
with oral contraceptives.
Cyclessa(TM) is designed to significantly reduce women's overall
hormonal exposure while maintaining contraceptive efficacy.
Cyclessa(TM) 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(TM)
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(TM) is an excellent triphasic oral contraceptive choice for
all women, including first time users and women switching from
another pill. In clinical trials, Cyclessa(TM) 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(TM) joins Mircette(R) and Desogen(R) 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(TM) 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.
Organon Inc. of West Orange, NJ, is the US affiliate of N.V. Organon, a
renowned international ethical pharmaceutical company. Organon
maintains a strong commitment to healthcare conducting research in
the areas of contraception, fertility, and hormone replacement
therapy. In addition to its strong presence in reproductive
medicine, Organon markets a wide range of pharmaceuticals and leads
groundbreaking research programs in the fields of anesthesiology,
psychiatry, and immunology.
Organon is one of the business units of Akzo Nobel N.V. Akzo Nobel,
headquartered in the Netherlands, is a market-driven and
technology-based company, serving customers throughout the world with
healthcare products, coatings and chemicals. The company employs
70,000 people and has activities in more than 70 countries.
Akzo Nobel common stock is listed on the NASDAQ stock exchange as
American Depositary Receipts (ADRs) under the name AKZOY.
Editors' Note: Full prescribing information is available upon request.