Ortho Tri-Cyclen Tablets (norgestimate/ethinyl estradiol)
Company: Ortho Pharmaceutical
Approval Status: Approved January 1997
Treatment for: acne
Areas: Dermatology/Plastic Surgery; Obstetrics/Gynecology
Possible similar drugs: Ortho Evra
| General Information | Clinical Results |
General Information
Ortho Tri-Clyclen Tablets (norgestimate/ethinyl estradiol) has been approved as a treatment for acne in women seeking contraception.
Varying levels of severity of acne at different points of the menstrual cycle have been reported. Research has demonstrated that Ortho Tri-Cyclen decreases the level of hormones, which contribute to the development of acne-producing agents, thus attacking the cause of the acne.
Ortho Tri-Cyclen, introduced in 1992, is the only oral contraceptive cleared in the United States for the treatment of moderate acne vulgaris in women 15 years of age or older; who have no known contraindication to oral contraceptive therapy; who desire contraception; who have begun menstruation and who are unresponsive to topical anti-acne medications. It is also indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.
Clinical Results
In the clinical studies, Ortho Tri-Cyclen showed improvement of acne similar to those seen in studies looking at efficacy or benzoyl peroxide and topical or systemic antibiotics. Ortho Tri-Cyclen treats acne with a combination of ethinyl estradiol, a synthetic estrogen, and norgestimate, a progestin. Two randomized, double-blind, placebo-controlled studies demonstrated that improvement of acne was reported during use of Ortho Tri-Cyclen in more than 80 percent of the studies’ participants treated with Ortho Tri-Cyclen.
The FDA drug information shown here is licensed from Thomson CenterWatch. The information provided here is for general educational purposes only and does not constitute medical or pharmaceutical advice which should be sought from qualified medical and pharmaceutical advisers.
