Effects of testosterone therapy for women: a systematic review and meta-analysis protocol

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madman

Super Moderator
Abstract

Background: Testosterone therapy for women is in widespread use, primarily in the form of compounded preparations and off-label use of formulations for men. The benefits and risks of such therapy remain uncertain. This review will identify and evaluate studies that have examined the effects of testosterone therapy for women on a range of outcomes including sexual function, cardiovascular events, metabolic parameters, musculoskeletal health, wellbeing, cancer events, androgenic effects and withdrawal rates.

Methods: Studies meeting our pre-determined inclusion criteria will be identified through searches in Ovid MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials (CENTRAL) and Web of Science. Assessing a range of outcomes, we will assess the risk-of-bias of relevant studies and draw conclusions about the strength of evidence for benefits and risks of testosterone therapy for each outcome.

Discussion: This comprehensive systematic review with meta-analysis will provide the foundation for the development of evidence-based clinical practice guidelines that will address benefits and risks of testosterone therapy, when treatment might be appropriate or inappropriate, areas of clinical uncertainty and the basis for assessment and monitoring of patients.




Discussion

Despite the prescribing of testosterone to women which is occurring globally [21], primarily for the treatment of low libido [22], internationally agreed guidelines for the use of testosterone in women are lacking. This systematic review, with meta-analysis, will provide a comprehensive systematic analysis of clinical studies that have examined the effects of systematic testosterone therapy in women on sexual function, cardiovascular events, metabolic parameters, musculoskeletal health and wellbeing. Strengths of this review include searching all the major clinical medicine data bases and the references of retrieved articles, not limiting our search to English publications, and recontacting authors for missing data. Although we cannot fully anticipate the limitations of our review, it is possible that we will not be able to get access to all studies published in languages other than English. This review will provide a critical basis for the development of evidence-based clinical practice guidelines for the indications and contra-indications to therapy, the benefits and risks of therapy, the areas of clinical uncertainty and the assessment and monitoring of patients. Thus, it is the first step towards filling this important gap in women’s health care. The findings of this review will be presented at international conferences and published in the relevant journal/s.
 

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