Register for New low-dose Ortho Tri-Cyclen approved by FDA
ContraceptionOctober 3, 2002
2002 OCT 3 - (NewsRx.com & NewsRx.net) -- The U.S. Food and Drug Administration (FDA) has approved a new oral contraceptive, Ortho Tri-Cyclen Lo (norgestimate/ethinyl estradiol) Tablets for the prevention of pregnancy. Ortho Tri-Cyclen Lo will be available by prescription in the fall.
Like other oral contraceptives, Ortho Tri-Cyclen Lo, is highly effective when taken correctly. It contains a combination of hormones - estrogen and the progestin norgestimate.
Ortho Tri-Cyclen Lo was developed by Ortho-McNeil Pharmaceutical, Inc.
"Ortho Tri-Cyclen Lo is an important new option in birth control, and one that I believe women will be excited about," said Ronald T. Burkman, MD, Bay State Medical Center, department of obstetrics and gynecology, Springfield, Massachusetts "The distinctive combination of a lower dose of estrogen with the trusted progestin, norgestimate, provides women a new option in birth control that is highly effective and has a favorable side effect profile."
While all combination birth control pills contain a progestin, Ortho Tri-Cyclen Lo and Ortho Tri-Cyclen contain norgestimate, a progestin with more than 10 years of proven clinical performance. By lowering the levels of serum free testosterone in a woman's body, the profile of norgestimate is associated with low rates of nuisance side effects such as weight gain, acne, and facial hair growth. Almost 50% of women who stop using the Pill do so because of side effects often related to the dose and type of hormones in the Pill.
The new, low-dose formulation provides a daily 25 mcg dose of estrogen for 21 days and three different doses of norgestimate (180 mcg daily/days 1-7; 215 mcg daily/days 8-14; 250 mcg daily/days 15-21). The last 7 days contain no active ingredients.
This article was prepared by Women's Health Weekly editors from staff and other reports.
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