A two-year, double-blind comparison of estrogen-androgen and conjugated estrogens in surgically menopausal women - Effects on bone mineral density, symptoms and lipid profiles

OBJECTIVE: To compare the effects of two doses of conjugated equine estroge n (CEE) and two of esterified estrogen pills methyltestosterone (E+A) ill s urgically menopausal women. STUDY DESIGN: A two-year parallel-group, double-blind study of 311 women wh o were randomly assigned to one of four regimens: (1) GEE, 0.625 mg/d; (2) GEE, 1.25 mg/d; (3) esterified estrogens, 0.625 mg, + methyltestosterone, 1 .25 mg/d; or (4) esterified estrogens, 1.25, + methyltestosterone, 2.5 mg/d . Study parameters were symptoms, lipids, bone mineral density, side effect s and safety. RESULTS: All treatments prevented loss of bone ill the spine and hip. The h igher E+A dose increased spine and hip BMD mort than other treatments (P < .002). All treatments improved menopausal symptoms, with non-significantly greater improvements in veil-being and sexual interest in the E+A groups. S imilar and significant decreases in low-density lipoprotein were observed i n all groups, but high-density lipoprotein and triglycerides were increased only in the unopposed estrogen groups (P < .05). Hirsutism was uncommon an d similar in all groups at two years. Discontinuation rates and reasons for withdrawal from the study were similar in both groups. No clinically signi ficant side effects or laboratory test abnormalities were seen. CONCLUSION: As compared to estrogen alone, E+A significantly improved BMD a nd was well tolerated in surgically menopausal women.