Conjugated Estrogens Combined With Sequential Dydrogesterone or Medroxyprogesterone Acetate in Postmenopausal Women

Abstract

This double-blind comparison of oral conjugated estrogens combined with cyclical dydrogesterone or medroxyprogesterone acetate was conducted in postmenopausal women. In this 1-year, double-blind, randomized, parallel-group, multicenter study, 41 postmenopausal women received 0.625 mg/day of conjugated estrogens plus 10 mg/day of dydrogesterone for 14 days/cycle; and 36 received 0.625 mg of conjugated estrogens plus 10 mg/day of medroxyprogesterone acetate for 14 days/cycle. Changes in lipid and lipoprotein parameters (predictive of reduced cardiovascular risk) were significantly greater in patients receiving 0.625 mg of conjugated estrogens plus 10 mg of dydrogesterone. Dydrogesterone had no adverse impact on glucose tolerance, but circulating glucose levels significantly increased in patients receiving 0.625 mg of conjugated estrogens plus 10 mg of medroxyprogesterone acetate after glucose tolerance testing. Patients receiving conjugated estrogens (0.625 mg) plus dydrogesterone (10 mg) had significantly fewer days with bleeding (51.90 ± 27.52 days) and reduced duration of bleeding episodes (5.56 ± .24 days) than patients receiving conjugated estrogens (0.625 mg) plus medroxyprogesterone acetate (10 mg) (71.40 ±29.63 and 6.74 ± 1.91 days, respectively). Both regimens provided good endometrial protection and relieved somatic, psychosomatic, and psychological menopausal symptoms. Adverse events, vital signs, and clinical laboratory findings were similar for both groups. In combination with conjugated estrogens, dydrogesterone induced a better cardiovascular risk factor profile and induced less vaginal bleeding than medroxyprogesterone acetate.