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

Abstract

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.

Trial registration: Thai Clinical Trials Registry identifier: TCRT20180423001.

Chinese abstract

目的：本研究旨在探讨雌激素联合低剂量睾酮凝胶改善绝经后妇女性功能的有效性和安全性。

方法：采用一项双盲、随机、平行对照试验的方法。70名性功能低下的绝经后妇女被随机分为两组。他们每周应用50mg经皮睾酮加每日口服1mg戊酸雌二醇8周或仅服用雌激素8周。治疗前后对女性性功能指数（FSFI）评分、红细胞压积、肝酶、血脂、总睾酮、游离睾酮和生物可利用睾酮、游离睾酮指数、性激素结合球蛋白（SHBG）和子宫内膜厚度进行评估。

结果：8周后, 两组的FSFI评分均显著提高。然而, 睾酮组的FSFI评分变化明显高于雌激素组, 分别为7.2±5.5和4.6±3.9（P=0.02）。睾酮组血清总睾酮水平显著升高, 但不是游离睾酮或生物可利用睾酮的形式。两组治疗后血清SHBG水平无显著性差异。无严重不良反应, 仅发现痤疮。

结论：在日常雌激素应用中添加应用低剂量睾酮凝胶可改善绝经后妇女的性功能, 但还需要进一步的评估和安全性方面的数据。

Keywords:

• Testosterone
• androgen
• sexual function
• postmenopause
• hormone therapy
• Female Sexual Function Index

Acknowledgements

The authors would like to thank Professor Nimit Taechakraichana, MD, for support, Associate Professor Surasith Chaitongwongwattana, MD, for analyzing the data, Miss Pirapon June Ohata for manuscript editing, and Ms Somtawin Pojjanasopanakun for assistance in conducting the research which would not have been possible without her strong dedication and commitment to the study.

Conflict of interest

The authors declare that they have no conflict of interests or financial relationships relevant to this article.

Additional information

Funding

This research was supported by the Ratchadapiseksompotch Fund, Faculty of Medicine, Chulalongkorn University.