Body composition during treatment with conjugated estrogens with and without medroxyprogesterone acetate: analysis of the women's Health, Osteoporosis, Progestin, Estrogen (HOPE) trial.

Abstract

The objective of the study was to determine the effects of several doses of conjugated estrogens (CE) and CE plus medroxyprogesterone acetate (MPA) on body composition (BC). This was a randomized, double-blind, placebo-controlled substudy of the Women's Health, Osteoporosis, Progestin, Estrogen (HOPE) trial. Healthy women (n = 822, 1-4 years after menopause) were randomly assigned to receive the following treatments daily for 2 years: CE, 0.625 mg; CE, 0.625 mg, and MPA, 2.5 mg; CE, 0.45 mg; CE, 0.45 mg, and MPA, 2.5 mg; CE, 0.45 mg, and MPA, 1.5 mg; CE, 0.3 mg; CE, 0.3 mg, and MPA, 1.5 mg; or placebo. Body weight (BW) was assessed every 3-4 cycles and fat body mass (FBM), lean body mass (LBM), and percent body fat (PBF) at cycles 6, 13, 19, and 26. In the placebo group, BW, FBM, and PBF increased at each visit during the study. Changes in these parameters were smaller in the active groups. These effects were independent of CE dose and the presence of MPA. Changes in LBM were small and comparable across groups. Treatment with CE or CE and MPA for up to 2 years does not affect BC.