Objective. To compare the effects of continuous 17- estradiol-only silastic implants with those of continuous 17- estradiol plus continuous nomegestrol acetate silastic implants on symptom control, lipid profile and tolerability in postmenopausal women. Methods. This was an open-label, parallel-group study. Women with and without uterus and no contraindications to hormone therapy (HT) in this study, we consider as HT the replacement of Estrogens-only and Estrogens+Progestogens Therapy, were enrolled. Each subject was assigned to receive four 17- estradiol-only silastic implants (women without uterus), or four 17- estradiol plus one nomegestrol acetate silastic implant (women with intact uterus), for 1 year. Results. A total of 40 subjects were enrolled and received, the silastic implants of which 40 (100.0%) subjects completed the study (n=20, estradiol only; n=20, estradiol plus nomegestrol acetate). The incidence of postmenopausal symptoms decreased significantly. No significant decreases in total cholesterol (1.3%), low-density lipoprotein cholesterol (1.1%), triglycerides (1.2%) and fasting glucose ((1.3%) serum levels were observed in both groups, whereas high-density lipoprotein (HDL) cholesterol increased significantly (2.8%), during the study in both groups. The incidences of adverse events were similar in both treatment groups. Conclusions. Women treated with 17- estradiol-only silastic implants or 17- estradiol plus nomegestrol acetate silastic implants showed significant improvement of postmenopausal symptoms, including urogenital and sexual health symptoms and a significant increase in HDL cholesterol and no significant differences in other lipid profiles and tolerability.
