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 combined with nomegestrol acetate, a 19-norprogesterone derivative, on cardiovascular risk factors. Design: A double-blind randomized prospective study comparing the effect of a placebo and two oral E(2)-nomegestrol acetate combinations (1 mg-2.5 mg and 1.5 mg-3.75 mg) over a three-cycle trial. Setting: Department of Internal Medicine and Nutrition, Hotel-Dieu, Paris, France. Patients: Fifty-seven nonhysterectomized women with natural menopause. Main Outcome Measures: Blood pressure, renin substrate, glucose, total cholesterol, high-density and low-density lipoprotein cholesterol, triglycerides, apoproteins Al and B, lipoprotein(a), antithrombin III, fibrinogen, plasminogen, prothrombin fragment 1 + 2, protein C, and total and free protein S. Results: Both treatments significantly reduced menopausal complaints, total cholesterol, low-density lipoprotein cholesterol and lipoprotein(a). Treatment with the 1.5 mg-3.75 mg combination resulted in a significant increase in apolipoprotein A1. No significant change were observed in other parameters. Conclusions: Sequentially combined with oral E(2) in hormone replacement therapy, nomegestrol acetate had favorable effects on plasma lipids and lipoproteins. This nonandrogenic progestin decreased lipoprotein(a) levels as observed previously with medroxyprogesterone acetate combined with conjugated equine estrogens.