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FDA Approves Oral Progesterone Prometrium MARIETTA, GA -- May 19, 1998 -- The United States Food and Drug Administration has approved Solvay Pharmaceuticals, Inc.’s Prometrium® (Progesterone, USP) Capsules for the treatment of secondary amenorrhea. Prometrium is the first oral dosage form of micronized progesterone and is synthesised from yams that is structurally identical to the natural progesterone found in a woman's body. Micronization increases the absorption of progesterone. An application is currently under review by FDA for hormone replacement therapy. Secondary amenorrhea refers to the abnormal cessation of menses in women who would otherwise be menstruating. 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. "This is excellent news for women," said Dr. Rogerio Lobo, professor and chairman, department of obstetrics and gynecology, College of Physicians & Surgeons, Columbia University. "Concomitant use of estrogens and progesterone had a favourable effect on HDL, LDL and triglycerides [compared to placebo]. In addition, reports of bloating and fluid retention with micronized progesterone were no different than placebo." "Progesterone has been overshadowed by estrogen, which is assumed by many women to be the most important reproductive hormone in their bodies," said Dr. Robert Rebar, professor and chairman, department of obstetrics and gynecology, University of Cincinnati College of Medicine. "But progesterone plays a pivotal role in women's health and as public health educators, we need to better educate women about this hormone." 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. The most common side effects of the product are dizziness, abdominal cramping, headache and breast pain. More information on: Solvay Pharmaceuticals Inc. E-mail this page to a friend or colleague! To print, use this version