Hormonal, metabolic, and endometrial safety of testosterone vaginal cream versus estrogens for the treatment of vulvovaginal atrophy in postmenopausal women: a randomized, placebo-controlled study.

Objective: The aim of the study was to evaluate the laboratory and endometrial safety of topical testosterone versus topical estrogen for the treatment of vaginal atrophy in postmenopausal women.

Methods: This was a randomized, placebo-controlled trial of 60 postmenopausal women aged 40 to 70 years at the Menopause Clinic of CAISM UNICAMP. Women were randomized into three vaginal treatment groups: estrogen, testosterone, or placebo. The treatment was applied 3 times a week for 12 weeks. Hormonal laboratory values of follicle-stimulating hormone, luteinizing hormone, estradiol, estrone, androstenedione, total testosterone, free testosterone, dehydroepiandrosterone, dehydroepiandrosterone sulfate, and sex hormone-binding globulin were assessed at baseline and at 6 and 12 weeks. Metabolic laboratory values of total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, triglycerides, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, and gamma-glutamyl transpeptidase were also assessed at baseline and at 6 and 12 weeks. Endometrial safety was assessed using ultrasonography at baseline and at 12 weeks.

Results: After 12 weeks of treatment, there were no significant differences in hormonal or metabolic laboratory values among all three groups. Two participants in the estrogen group had increased serum estradiol after 12 weeks of treatment. No change in endometrial thickening was reported in all three groups.

Conclusions: Twelve weeks of treatment with topical testosterone or estrogen in postmenopausal women with symptoms of vaginal atrophy demonstrated laboratory and endometrial safety when compared with placebo.