NEW YORK, Dec 21 (Reuters Health) -- The Food and Drug Administration (FDA) granted approval of a new oral form of the hormone progesterone for use with estrogen replacement therapy.
The new drug, Prometrium, contains a progesterone synthesized from yams. It is approved for use with estrogen in postmenopausal women who have not had a hysterectomy, with the goal of preventing estrogen-associated endometrial hyperplasia, overgrowth of the uterine lining that can lead to cancer.
The drug is "structurally identical" to endogenous progesterone, according to its manufacturer, Solvay Pharmaceuticals, Inc., of Marietta, Georgia. The company also notes that Prometrium capsules are the first oral micronized progesterone to receive FDA approval. "Micronized" means that the particle size of the drug has been reduced to enable the body to absorb it more effectively.
Approval was granted in part on the results of the Postmenopausal Estrogen/Progestin Interventions Trial (PEPI), a 3-year study that showed that the addition of progesterone to estrogen resulted in higher blood levels of HDL ("good") cholesterol compared with estrogen alone.
Women on estrogen plus Prometrium in the PEPI trial also had lower rates of endometrial hyperplasia than women on estrogen alone.
The FDA recommends a dose of 200 mg for 12 sequential days per 28-day cycle as part of postmenopausal hormone replacement therapy.
Solvay notes that Prometrium has already been approved for use in the treatment of secondary amenorrhea, where menstrual periods have stopped in women who would normally be menstruating.
