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FDA approves hormone treatment drug (5/22/98)

The U.S. Food and Drug Administration's approval of Prometrium, a micronized progesterone, should come as good news to millions of women and their doctors who have been waiting for a commercially available, FDA approved micronized progesterone, said a University of Texas Health Science Center at San Antonio professor who helped lead a study of Prometrium.

Micronized progesterone is a progesterone whose particles have been reduced in size for better absorption, and is structurally identical to the progesterone a woman naturally produces. Micronized progesterone was used in the PEPI (Postmenopausal Estrogen/Progestin Intervention) study sponsored by the National Institutues of Health. PEPI was a trial that examined the effects of various regimens of hormone replacement therapy, studying the use of estrogen alone and in combination with both micronized progesterone and progestin (a synthetic version of the progesterone that is not structurally identical to a woman's own hormone). The University of Texas Health Science Center at San Antonio was one of the study's core research centers

"One of the unexpected findings of PEPI was that the estrogen and micronized progesterone regimen protected the heart by raising HDL-C ("good cholesterol") levels.

HDL-C levels were not affected as favorably when the synthetic progestin was used in combination with estrogen. Furthermore, micronized progesterone was also effective at protecting women from endometrial hyperplasia, the overgrowth of the uterine lining associated with estrogen use," said Dr. Jose T. Trabal, associate professor of obstetrics and gynecology at the Health Science Center. "With more than 60 million women expected to be postmenopausal by the year 2000, the approval of a new therapy is welcome news indeed."

Contact: Myong Covert (210) 567-2570