CARDIOVASCULAR RISK-FACTORS AND COMBINED ESTROGEN-PROGESTIN REPLACEMENT THERAPY - A PLACEBO-CONTROLLED STUDY WITH NOMEGESTROL ACETATE AND ESTRADIOL

Objective: To assess the effects of oral E(2) replacement therapy comb ined with nomegestrol acetate, a 19-norprogesterone derivative, on car diovascular risk factors. Design: A double-blind randomized prospectiv e study comparing the effect of a placebo and two oral E(2)-nomegestro l acetate combinations (1 mg-2.5 mg and 1.5 mg-3.75 mg) over a three-c ycle trial. Setting: Department of Internal Medicine and Nutrition, Ho tel-Dieu, Paris, France. Patients: Fifty-seven nonhysterectomized wome n with natural menopause. Main Outcome Measures: Blood pressure, renin substrate, glucose, total cholesterol, high-density and low-density l ipoprotein cholesterol, triglycerides, apoproteins Al and B, lipoprote in(a), antithrombin III, fibrinogen, plasminogen, prothrombin fragment 1 + 2, protein C, and total and free protein S. Results: Both treatme nts significantly reduced menopausal complaints, total cholesterol, lo w-density lipoprotein cholesterol and lipoprotein(a). Treatment with t he 1.5 mg-3.75 mg combination resulted in a significant increase in ap olipoprotein A1. No significant change were observed in other paramete rs. Conclusions: Sequentially combined with oral E(2) in hormone repla cement therapy, nomegestrol acetate had favorable effects on plasma li pids and lipoproteins. This nonandrogenic progestin decreased lipoprot ein(a) levels as observed previously with medroxyprogesterone acetate combined with conjugated equine estrogens.