Research
ArticlesSafety and efficacy of testosterone for women: a systematic review and meta-analysis of randomised controlled trial data
Introduction
No international consensus exists to guide use of testosterone in women. Nonetheless, clinicians have treated women with various forms of testosterone for decades, primarily for diminished sexual wellbeing.1 Previous systematic reviews of testosterone treatment for women have indicated favourable effects on sexual function,2, 3 but these analyses have included scant data for safety or adverse effects. We did a systematic review and meta-analysis of randomised controlled trials that reported the effects of systemic testosterone treatment compared with placebo or a comparator (eg, oestrogen, with or without progestogen) on sexual function, cardiometabolic variables, cognitive measures, and musculoskeletal health, including previous unpublished data.
Section snippets
Search strategy and selection criteria
This systematic review and meta-analysis was done in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement.4 We searched MEDLINE, Embase, the Cochrane Central Register of Controlled Trials, and Web of Science using Ovid software. The full search strategy and keywords used have been published elsewhere.5 We also searched drug registration applications to the European Medicine Agency (EMA) and the US Food and Drug Administration (FDA).
Results
A PRISMA flowchart of study selection is presented in figure 1. The overall search resulted in 6491 citations. 2651 duplicate studies were excluded; a further 3769 studies were excluded on review of title and abstract, and 25 reports did not meet inclusion criteria. Thus, 46 publications from 36 randomised controlled trials were included in the meta-analysis. 44 reports8, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45,
Discussion
The findings of our systematic review and meta-analysis show beneficial treatment effects of testosterone for postmenopausal women on a comprehensive array of sexual function domains, the frequency of satisfying sexual events, and sexually associated personal distress. For premenopausal women, the only observed benefit was a reduction in sexually associated personal distress in one small study. Although testosterone treatment was associated with an increase in acne and hair growth, these
References (69)
- et al.
Meta-analysis in clinical trials
Control Clin Trials
(1986) - et al.
Comparative evaluation of the reliability and validity of three data extraction programs: UnGraph, GraphClick, and DigitizeIt
Comput Human Behav
(2016) - et al.
Testosterone enhances estradiol's effects on postmenopausal bone density and sexuality
Maturitas
(1995) - et al.
The benefits of androgens combined with hormone replacement therapy regarding to patients with postmenopausal sexual symptoms
Maturitas
(2007) - et al.
Serum lipids in oophorectomized women during estrogen and testosterone replacement therapy
Maturitas
(2004) - et al.
Testosterone improves antidepressant-emergent loss of libido in women: findings from a randomized, double-blind, placebo-controlled trial
J Sex Med
(2014) - et al.
Effect of percutaneous androgen replacement therapy on body composition and body weight in postmenopausal women
Maturitas
(1998) - et al.
Safety and efficacy of low-dose esterified estrogens and methyltestosterone, alone or combined, for the treatment of hot flashes in menopausal women: a randomized, double-blind, placebo-controlled study
Fertil Steril
(2011) - et al.
Comparative effects of oral esterified estrogens with and without methyltestosterone on endocrine profiles and dimensions of sexual function in postmenopausal women with hypoactive sexual desire
Fertil Steril
(2003) - et al.
Treatment with percutanous testosterone gel in postmenopausal women with decreased libido: effects on sexuality and psychological general well-being
Maturitas
(2006)