THE EFFECTS OF ESTRADIOL VALERATE PLUS MEDROXYPROGESTERONE ACETATE AND CONJUGATED ESTROGENS PLUS MEDROGESTONE ON CLIMACTERIC SYMPTOMS AND METABOLIC VARIABLES IN PERIMENOPAUSAL WOMEN

Background. Two sequential hormone replacement regimens, containing ei ther estradiol valerate plus medroxyprogesterone acetate (E(2)V/MPA) o r conjugated estrogens plus medrogestone (CE/MED), were compared with respect to effects on climacteric symptoms, lipid metabolism, and hemo stasis. Methods. In an open, multicenter study, 51 perimenopausal wome n were randomized to E(2)V/MPA and 50 to CE/MED. Assessment of climact eric complaints was performed at baseline and at months 1, 3, and 6. T he effects on lipid and hemostatic variables were measured at baseline and at month 6. Quantitative data were analyzed using analysis of var iance, the paired t-test, or the chi(2) Mantel-Hanszel test, where app ropriate. Results. Efficacy regarding treatment of climacteric symptom s was with E(2)V/MPA as good as with CE/MED, with a statistically sign ificant reduction of most symptoms in both groups. After 6 months, tot al cholesterol and triglycerides had remained unchanged in both groups . High-density lipoprotein cholesterol showed no significant change wi th E(2)V/MPA, whereas an increase was noted in the CE/MED group (p<0.0 5). Low-density lipoprotein cholesterol was decreased with E(2)V/MPA ( p<0.01) and was unchanged in the CE/MED group. Hemostatic parameters s howed no significant changes after 6 months, with the exception of a d ecreased prothrombin time with E(2)V/MPA (p<0.05). Acceptability was e xcellent, expressed by the low incidence of treatment-related drop-out s in both groups. Conclusions. E(2)V/MPA is a one tablet per day seque ntial HRT regimen, which is as effective and acceptable as hormone rep lacement therapy with CE/MED regarding treatment of climacteric sympto ms. Neither preparation had negative effects on lipid metabolism and h emostatic variables.