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Title: Canada Approves Alesse (Estradiol/Levonorgestrel) for Acne for Women

"Canada Approves Alesse (Estradiol/Levonorgestrel) for Acne for Women"

MARKHAM, ON -- January 31, 2002 -- Health Canada has approved Alesse™ (estradiol/levonorgestrel) as an effective treatment for moderate acne in women. Clinical trials in Canada and other countries studied 721 women with acne. Results showed that 56.9 percent of Alesse-treated women reported clear or almost clear complexion after six months of treatment. Moreover, 88 percent of the patients using Alesse self-assessed their acne as improved after six menstrual cycles of therapy (1). "The effects of untreated acne can be disturbing both emotionally and physically," said Dr. André Lemay, study investigator, endocrinologist, biochemist and professor in the department of Obstetrics and Gynecology at Laval University in Quebec. "The data show that Alesse not only provides excellent birth control, but can now treat moderate acne in women." Acne is caused by a variety of factors including stress, heredity, lifestyle and hormones. Affecting up to 80 percent of all Canadians, women typically experience more acne than men due to fluctuations in hormone levels. Although acne usually develops during adolescence, many women will continue to have it throughout their adult years. Alesse was approved in January, 1998 as an oral contraceptive and is the lowest dose combination levonorgestrel birth control pill available in Canada. Alesse contains two female sex hormones -- estrogen (ethinyl estradiol) and progestin (levonorgestrel) and is considered a low-dose estrogen birth control pill. Many international regulatory bodies, including the World Health Organization, recommend the lowest dose formulation possible as the safest option for women. In addition, the Special Advisory Committee to Health Canada recommends that women use as low a dose of estrogen as possible (2). In clinical trials, side effects commonly linked to the birth control pill (weight change, nausea, breast tenderness and headache) were actually found to be similar between those taking Alesse and those on placebo. References: (1) Thiboutot, D., Archer, D., Lemay A., Washenik, K., Roberts, J., Harrison, D. A randomized, controlled trial of a low-dose contraceptive containing 20 (micro)g of ethinyl estradiol and 100 (micro)g of levonorgestrel for acne treatment, J Fertility and Sterility, Vol. 76, No. 3, September 2001 pp. 461-468. (2) A report by the Special Advisory Committee on Reproductive Physiology to the Drugs Directorate Health Protection Branch Health Canada. SOURCE: Wyeth-Ayerst Canada Inc.

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