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| |  FDA Approves Prometrium For Use With Hormone Replacement Therapy MARIETTA, GA -- Dec. 21, 1998 -- The United States Food and Drug Administration has approved Solvay Pharmaceuticals, Inc.’s Prometrium(R) (progesterone, USP) Capsules, an oral micronized progesterone for use with estrogen therapy. The drug is indicated for prevention of cell overgrowth in the uterine lining in postmenopausal women who have not had a hysterectomy and for treatment of secondary amenorrhea. Prometrium Capsules is a progesterone synthesised from yams that is structurally identical to endogenous (naturally-occurring) progesterone found in a woman's body. Micronisation makes the progesterone easier for the body to absorb. The Postmenopausal Estrogen/Progestin Interventions (PEPI) trial, a three-year NIH study, examined the effects of estrogen alone and in combination with both medroxyprogesterone acetate (MPA) and Prometrium Capsules. PEPI found that, when taken alone, estrogen positively affected HDL-C, or good cholesterol levels. The addition of Prometrium Capsules did not appear to negate the positive effects of oral estrogen on good cholesterol. In fact, women taking the estrogen and Prometrium Capsules regimen experienced the highest increase in levels of good cholesterol compared to the estrogen and MPA regimens. The estrogen and Prometrium Capsules regimen also reduced the risk of endometrial hyperplasia when compared to estrogen alone. The suggested dose for Prometrium Capsules for use in HRT is 200 mg taken orally once a day, in the evening, for 12 sequential days per 28 day cycle. Used widely in Europe, oral micronized progesterone was first introduced in France in 1980 and is marketed in more than 25 countries, including Canada. Prometrium Capsules was introduced in the United States in June of this year for treatment of secondary amenorrhea. Progesterone is the female sex hormone responsible for changes in the uterine lining during the second half of the menstrual cycle throughout a woman's reproductive life. Progesterone derivatives, known collectively as progestin, are commonly used in combination with estrogen when estrogen is prescribed to alleviate vasomotor symptoms of menopause or to prevent osteoporosis in women with a uterus. Like estrogen, progesterone production drops significantly when a woman reaches menopause. A recent survey conducted by Yankelovich Partners of 1,000 women age 40 plus found that only eight percent named progesterone as one of the hormones affected as a woman enters menopause, versus 32 percent who named estrogen. "Progesterone has been overshadowed by estrogen, which is assumed by many women to be the most important reproductive hormone in their bodies," said Dr. Jose Trabal, associate professor of obstetrics and gynecology at the University of Texas Health Science Center at San Antonio and one of the PEPI trial investigators. "But progesterone plays a pivotal role in women's health, especially for women with an intact uterus." Patients who may be allergic to peanuts, suffer from severe liver disease, or who have known or suspected breast cancer, or pregnancy should not take Prometrium Capsules. Common side effects of Prometrium Capsules are breast tenderness, dizziness, abdominal bloating and vaginal discharge.
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