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Title: ADA CONFERENCE: Drug Effective In Treating Polycystic Ovary Syndrome
URL: http://www.pslgroup.com/dg/84F7E.htm
Doctor's Guide
June 15, 1998


CHICAGO, IL -- June 15, 1998 -- Clinical study results of Insmed Pharmaceuticals, Inc.'s INS-1, presented at the 58th scientific sessions of the American Diabetes Association, show that the drug is effective in producing ovulation in women with polycystic ovary syndrome (PCOS).

The absence of ovulation, related to increases in insulin and testosterone levels, is the most common symptom of PCOS.

The randomised, double-blind, placebo-controlled study involved 44 obese women with PCOS who received either a single oral dose of INS-1 or placebo for up to six weeks. At the end of the study, 86 percent of the women treated with INS-1 had ovulated, compared to only 27 percent of women in the placebo group.

Women who received INS-1 also experienced significant decreases in serum insulin and testosterone levels, while women in the placebo group experienced no significant change in these markers. The adverse experiences were similar in type, severity and duration in the two treatment groups.

The study was conducted by Daniela Jakubowicz, MD, at the Hospital Clinicas de Caracas in Venezuela in collaboration with John Nestler, MD, at the Medical College of Virginia.

Polycystic ovary syndrome (also known as the Stein-Leventhal Syndrome or hyperandrogenic anovulation) is an endocrine disorder that produces an imbalance in women's hormone levels. PCOS is the major cause of infertility due to the excessive secretion of androgens and the absence of ovulation. In the United States alone, the disorder affects up to 10 percent, or six million, pre-menopausal women.

PCOS causes production of abnormal levels of follicle stimulating hormones and luteinizing hormones which prevent women from ovulating regularly. The disorder also produces abnormally high levels of androgens, primarily testosterone and androstenedione, which cause acne, male-pattern hair loss and excessive facial and body hair. The symptoms of the disorder vary based on a woman's genetic makeup, so that no two women are affected exactly the same way.

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