Efficacy of oral estrogen plus testosterone gel to improve sexual function in postmenopausal women

Objective: This study aimed to study the efficacy and safety of estrogen plus low-dose testosterone gel in improving sexual function in postmenopausal women. Methods: A double-blind, randomized, active-controlled trial was conducted. Seventy postmenopausal women with low sexual function were randomized into two groups. They received weekly 50 mg of transdermal testosterone plus daily oral 1 mg estradiol valerate or only estrogen for 8 weeks. The Female Sexual Function Index (FSFI) score, hematocrit, liver enzymes, lipid profiles, total testosterone, free and bioavailable testosterone, free androgen index, sex hormone binding globulin (SHBG), and endometrial thickness were assessed before and after treatment. Results: After 8 weeks, the FSFI score significantly improved in both groups. However, the change of FSFI score in the testosterone group was significantly higher than in the only estrogen group, 7.2 ± 5.5 and 4.6 ± 3.9, respectively (p = 0.02). There were significantly increased serum total testosterone levels, but not the free or bioavailable form, in the testosterone group. There was no significant difference in serum SHBG levels after treatment between both groups. There was no serious adverse effect, only acne was found. Conclusion: The addition of low-dose testosterone gel to daily estrogen may improve sexual function in postmenopausal women, but further evaluation and safety data are needed.