September 27, 2004
Low-dose version of Prempro approved
The FDA approved a low-dose version of Wyeth Pharmaceuticals' hormone replacement therapy Prempro (conjugated estrogens and medroxyprogesterone). The low-dose Prempro has 28 percent less estrogen and 40 percent less progestin than full-dose Prempro, Wyeth reported. It contains 0.45 mg of conjugated estrogens and 1.5 mg of medroxyprogesterone. This version is indicated for use in the treatment of moderate to severe vasomotor symptoms associated with menopause, such as hot flashes and night sweats. It is also approved for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy, such as vaginal dryness. Wyeth said data supporting the efficacy and tolerability of low-dose Prempro is based on the Women's HOPE study, which included 2,805 postmenopausal women.