Department of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Francisco, CA, USA.
Women's Health Research Program, School of Public Health and Preventive Medicine, Monash University Melbourne, VIC, Australia.
J Sex Med. 2020 Apr;17(4):585-594. doi: 10.1016/j.jsxm.2019.12.013. Epub 2020 Feb 13.
Testosterone has been studied for its benefits on sexual health for decades. The research regarding testosterone in women has produced evidence that this is a potential treatment for women suffering from female sexual dysfunction. There are several limitations of the testosterone trials that can affect their interpretation and challenges posed by some regulatory agencies that have prevented approval of any testosterone treatment for women in several countries.
To summarize the challenges of testosterone trials in terms of study populations, patient-reported outcomes, validated instruments in research, confounders, and regulatory barriers.
A thorough review of published data on testosterone for the treatment of women's sexual health problems was undertaken. A detailed evaluation of the limitations of these trials was conducted and incorporated with the published evidence on the regulatory processes involved in moving testosterone from clinical research to drug approval.
Main outcome measures are assessment of clinical trial populations, survey tools, confounders, and regulatory barriers.
There is some heterogeneity of study populations included in testosterone trials in women. Similarly, there have been differences in instruments used to assess patient-reported outcomes and often minimal control for potential confounders. The regulatory agency had posed a challenge to approve any testosterone treatment for women based on unproven concerns and a lack of regulatory guidance for drug developers.
There is strong evidence that shows testosterone is effective for treating sexual health concerns in the women included in clinical trials.
STRENGTH & LIMITATIONS: Strengths include thorough review of published literature and trial design for sexual health concerns. Limitations include being restricted to English Language publications and not having access to unpublished clinical trial data.
Testosterone trials in women have been limited by homogeneity in the study populations and outcomes measured. Drug development has been hampered by inconsistent regulatory barriers. Rowen TS, Davis SR, Parish S, et al. Methodological Challenges in Studying Testosterone Therapies for Hypoactive Sexual Desire Disorder in Women. J Sex Med 2020;17:585-594.
几十年来，人们一直在研究睾酮对性健康的益处。关于女性睾酮的研究已经证明，这是一种治疗女性性功能障碍的潜在方法。睾酮试验存在一些局限性，这些局限性可能会影响对它们的解释，以及一些监管机构提出的挑战，这些挑战阻止了在几个国家批准任何用于女性的睾酮治疗。
总结睾酮试验在研究人群、患者报告结局、研究中使用的验证工具、混杂因素和监管障碍方面的挑战。
对已发表的关于睾酮治疗女性性健康问题的文献进行了全面审查。对这些试验的局限性进行了详细评估，并结合了与将睾酮从临床研究推向药物批准的监管过程相关的已发表证据。
主要观察指标是评估临床试验人群、调查工具、混杂因素和监管障碍。
女性睾酮试验的研究人群存在一定的异质性。同样，用于评估患者报告结局的工具也存在差异，而且往往很少对潜在混杂因素进行控制。监管机构基于未经证实的担忧和缺乏药物开发者的监管指导，对批准任何女性睾酮治疗提出了挑战。
有强有力的证据表明，睾酮治疗对临床试验中纳入的女性的性健康问题有效。
优势包括对性健康问题的已发表文献和试验设计进行了全面审查。局限性包括仅限于英文文献发表，无法获得未发表的临床试验数据。
女性睾酮试验受到研究人群和测量结果的同质性限制。药物开发受到不一致的监管障碍的阻碍。Rowen TS、Davis SR、Parish S 等人。研究女性性欲低下障碍的睾酮疗法的方法学挑战。J 性医学 2020;17:585-594。
