Ortho Tri-Cyclen Tablets (norgestimate/ethinyl estradiol)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Approval Status:

Approved January 1997

Specific Treatments:

acne

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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.