Troglitazone Improves Ovulation And Hirsutism In Women With Polycystic Ovary Syndrome
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Troglitazone Improves Ovulation And Hirsutism In Women With Polycystic Ovary Syndrome

BETHESDA, MD -- April 11, 2001 -- A new study, published in the April issue of the Journal of Clinical Endocrinology & Metabolism, shows that troglitazone, an insulin-sensitizing agent and member of the thiazolidinedione class of drugs, improves ovulation and hirsutism in women who suffer from Polycystic Ovary Syndrome (PCOS), an endocrine disorder that effects seven to 10 percent of reproductive-age women.

"This study is the first trial of its size that shows long term changes in ovulatory function in women with PCOS," said Dr. Mahmoud Ghazzi, MD, PhD, a researcher and Senior Director of the Endocrine and Metabolism division at Pfizer Inc, (Parke-Davis, which funded the study, was a division of Warner- Lambert, which merged with Pfizer Inc in June 2000). "Additionally, this study is the first to show that using an insulin sensitizing agent results in improvement in hirsutism, which is often associated with PCOS."

The multicenter, double blind, placebo-controlled trial studied four hundred and ten premenopausal women with PCOS over 44 weeks. The subjects received either a placebo or troglitazone in doses of 150 mg, 300 mg or 600 mg per day.

Researchers at the University of Alabama, the University of Chicago Medical Center, Penn State University, Parke-Davis Pharmaceuticals and other academic institutions compared changes in ovulatory function, hirsutism, hormone levels and glycemic parameters in the different groups. They found that the patients who received 300 or 600 mg of troglitazone experienced significantly greater ovulatory rates compared with the placebo group. For example, 57 percent of the women who received 600 mg of troglitazone ovulated 50 percent of the time, compared with only 12 percent of the time in the placebo group.

The study also showed a significant decrease in the Ferriman-Gallwey score, which measures hirsutism in women, in the 600 mg group. In addition, the women who took troglitazone experienced a decrease in free testosterone and an increase in sex hormone-binding globulin. Glycemic parameters also showed a dose-related decrease in the women who took troglitazone.

"This research clearly demonstrates the therapeutic effects of ameliorating Hyperinsuliniemia, which include using an agent like troglitazone, to improve ovulatory dysfunction in women with PCOS," said Dr. Ghazzi. "Hopefully, these findings will help us better understand the mechanisms involved in PCOS and identify new ways to more effectively treat women who suffer from the devastating effects of PCOS. Additionally, since troglitazone is no longer available on the market, it would be tempting to conclude that other members of the same class (PPARy agonists) might have similar effects. However, further studies using those agents are needed to validate such a conclusion."

SOURCE The Endocrine Society

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