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

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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.

Systematic review registration

PROSPERO registration number: CRD42018104073

Related collections

Most cited references 10

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Abstract: found
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Androgen therapy in women: a reappraisal: an Endocrine Society clinical practice guideline.

Margaret Wierman, Wiebke Arlt, Rosemary Basson … (2014)

To update practice guidelines for the therapeutic use of androgens in women.

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Testosterone for low libido in postmenopausal women not taking estrogen.

Céline Bouchard, Margery Gass, Tessa Davis … (2008)

The efficacy and safety of testosterone treatment for hypoactive sexual desire disorder in postmenopausal women not receiving estrogen therapy are unknown. We conducted a double-blind, placebo-controlled, 52-week trial in which 814 women with hypoactive sexual desire disorder were randomly assigned to receive a patch delivering 150 or 300 microg of testosterone per day or placebo. Efficacy was measured to week 24; safety was evaluated over a period of 52 weeks, with a subgroup of participants followed for an additional year. The primary end point was the change from baseline to week 24 in the 4-week frequency of satisfying sexual episodes. At 24 weeks, the increase in the 4-week frequency of satisfying sexual episodes was significantly greater in the group receiving 300 microg of testosterone per day than in the placebo group (an increase of 2.1 episodes vs. 0.7, P<0.001) but not in the group receiving 150 microg per day (1.2 episodes, P=0.11). As compared with placebo, both doses of testosterone were associated with significant increases in desire (300 microg per day, P<0.001; 150 microg per day, P=0.04) and decreases in distress (300 microg per day, P<0.001; 150 microg per day, P=0.04). The rate of androgenic adverse events - primarily unwanted hair growth - was higher in the group receiving 300 microg of testosterone per day than in the placebo group (30.0% vs. 23.1%). Breast cancer was diagnosed in four women who received testosterone (as compared with none who received placebo); one of the four received the diagnosis in the first 4 months of the study period, and one, in retrospect, had symptoms before undergoing randomization. In postmenopausal women not receiving estrogen therapy, treatment with a patch delivering 300 microg of testosterone per day resulted in a modest but meaningful improvement in sexual function. The long-term effects of testosterone, including effects on the breast, remain uncertain. (ClinicalTrials.gov number, NCT00131495.) Copyright 2008 Massachusetts Medical Society.

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Minireview: aromatase and the regulation of estrogen biosynthesis--some new perspectives.

E R Simpson, S R Davis (2001)

There is a growing awareness that androgens and estrogens have general metabolic roles that are not directly involved in reproductive processes. These include actions on vascular function, lipid and carbohydrate metabolism, as well as bone mineralization and epiphyseal closure, in both sexes. In postmenopausal women, as in men, estrogen is no longer solely an endocrine factor, but instead is produced in a number of extragonadal sites and acts locally at these sites in a paracrine and intracrine fashion. These sites include breast, bone, vasculature, and brain. Within these sites, aromatase action can generate high levels of E2 locally without significantly affecting circulating levels. Circulating C(19) steroid precursors are essential substrates for extragonadal estrogen synthesis. The levels of these androgenic precursors decline markedly with advancing age in women, possibly from the mid to late reproductive years. This may be a fundamental reason why women are at increased risk for bone mineral loss and fracture and possibly decline of cognitive function, compared with men. Aromatase expression in these various sites is under the control of tissue-specific promoters regulated by different cohorts of transcription factors. Thus, in principle, it should be possible to develop selective aromatase modulators that block aromatase expression, for example, in breast, but allow unimpaired estrogen synthesis in other tissues such as bone.

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Author and article information

Contributors

Rakibul M. Islam:

ORCID: http://orcid.org/0000-0002-0889-8658

+61 3 9903 0374 , rakib.islam@monash.edu

Robin J. Bell: robin.bell@monash.edu

Sally Green: sally.green@monash.edu

Susan R. Davis: susan.davis@monash.edu

Journal

Journal ID (nlm-ta): Syst Rev

Journal ID (iso-abbrev): Syst Rev

Title: Systematic Reviews

Publisher: BioMed Central (London )

ISSN (Electronic): 2046-4053

Publication date (Electronic): 11 January 2019

Publication date PMC-release: 11 January 2019

Publication date Collection: 2019

Volume: 8

Electronic Location Identifier: 19

Affiliations

[1 ]ISNI 0000 0004 1936 7857, GRID grid.1002.3, Women’s Health Research Program, , Monash University, ; Melbourne, Australia

[2 ]ISNI 0000 0004 1936 7857, GRID grid.1002.3, School of Public Health and Preventive Medicine, , Monash University, ; Melbourne, Australia

Author information

Rakibul M. Islam http://orcid.org/0000-0002-0889-8658

Article

Publisher ID: 941

DOI: 10.1186/s13643-019-0941-8

PMC ID: 6329173

PubMed ID: 30635029

SO-VID: 589511e8-2e1c-400a-8b85-b0d22328b333

License:

Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

History

Date received : 21 August 2018

Date accepted : 3 January 2019

Funding

Funded by: FundRef http://dx.doi.org/10.13039/501100000925, National Health and Medical Research Council;

Award ID: APP1152778

Award ID: APP1135843

Award Recipient : Susan R. Davis

Custom metadata

ScienceOpen disciplines: Public health

Keywords: testosterone,women,premenopause,perimenopause,postmenopause,sexual function

Data availability:

ScienceOpen disciplines: Public health

Keywords: testosterone, women, premenopause, perimenopause, postmenopause, sexual function

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

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Abstract

Background

Methods

Discussion

Systematic review registration

Related collections

REPO4EU WP2 Systematic Reviews

Most cited references 10

Androgen therapy in women: a reappraisal: an Endocrine Society clinical practice guideline.

Testosterone for low libido in postmenopausal women not taking estrogen.

Minireview: aromatase and the regulation of estrogen biosynthesis--some new perspectives.

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Contributors

Journal

Affiliations

Author information

Article

History

Funding

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