BACKGROUND AND PURPOSE:

• While testosterone treatment for the improvement of low sexual desire in women is common, data on safety is limited
• Islam et al. (The Lancet Diabetes & Endocrinology, 2019) sought to determine the potential benefits and risks of testosterone treatment for women

METHODS:

• Systematic review and meta-analysis
• Data sources
  • MEDLINE, Embase, the Cochrane Central Register of RCTs and Web of Jan 1, 1990, and Dec 10, 2018
  • Drug registration applications to the European Medicine Agency and FDA was also searched for unpublished data
• Inclusion criteria
  • Blinded RCTs (minimum single blinded)
  • Duration of testosterone treatment ≥12 weeks
• Participants
  • Women 18 to 75 years of age
  • Premenopausal or postmenopausal (natural or surgical)
  • With or without concurrent hormone treatment
  • Intravaginal testosterone excluded
• Primary outcomes: the effects of testosterone on
  • Sexual function
  • Cardiometabolic variables
  • Cognitive measures
  • Musculoskeletal health

RESULTS:

• 36 RCTs | 8480 patients | Most studies appropriately excluded women with identifiable causes that should be treated with other options, and not testosterone (e.g., depression or anti-depressant use)
• Compared with placebo or a comparator (e.g., estrogen, with or without progestogen), testosterone significantly increased sexual function in postmenopausal women
  • Satisfactory sexual event frequency: Mean difference 0.85 (95% CI, 0.52 to 1.18)
  • Sexual desire: Standardized mean difference 0.36 (95% CI, 0.22 to 0.50)
  • Pleasure: Mean difference 6.86 (95% CI, 5.19 to 8.52)
  • Arousal: Standardized mean difference 0.28 (95% CI, 0.21 to 0.35)
  • Orgasm: Standardized mean difference 025 (95% CI, 0.18 to 0.32)
  • Responsiveness: Standardized mean difference 0.28 (95% CI, 0.21 to 0.35)
  • Self-image: Mean difference 5.64 (95% CI, 4.03 to 7.26)

Note: Data limited for premenopausal women and conclusions could not be drawn

• Compared with placebo or a comparator testosterone significantly reduced the following in postmenopausal women
  • Sexual concerns: Mean difference 8.99 (95% CI, 6.90 to 11.08)
  • Distress: Standardized mean difference −0.27 (95% CI, −0.36 to −0.17)
• Comparing oral testosterone to non-oral (e.g., transdermal patch or cream) for postmenopausal women
  • LDL-cholesterol levels increased
  • Total cholesterol decreased
  • HDL-cholesterol decreased
  • Triglycerides decreased
• Testosterone treatment was associated with an increase in weight in postmenopausal women
  • Weight gain mean difference 0.48 (95% CI, 0.16 to 0.79)
• No effects of testosterone were seen for the following (authors caution small ‘n’)
  • Body composition | Musculoskeletal variables | Cognitive measures
• Adverse events
  • Compared to placebo or comparator, testosterone was significantly associated with greater likelihood of reporting
    • Acne: Relative risk (RR) 1.46 (95% CI, 1.11o 1.92)
    • Hair growth: RR 1.69 (95% CI, 1.33 to 2.14)
  • There were no reported serious events such as alopecia or voice change

CONCLUSION:

• Testosterone treatment is effective for improving sexual function in postmenopausal women
• Non-oral route appears to have a superior lipid profile
• More long-term studies are needed
• The authors call for approved testosterone formulations, specifically for women and further state

Our comprehensive systematic review provides robust support for a trial of testosterone treatment, using a dose appropriate for women, when clinically indicated in postmenopausal women

Learn More – Primary Sources:

Safety and efficacy of testosterone for women: a systematic review and meta-analysis of randomised controlled trial data

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Testosterone Therapy for Low Desire – How, When and Where?

Treatment Options for the Patient with Low Sexual Desire

KEEPS Trial: What Are the Effects of Oral vs Transdermal Estrogen Therapy on Sexual Function?

What role does sleep disturbance play in sexual dysfunction?