In the JournalsPerspective

Testosterone therapy improves sexual function in postmenopausal women

Postmenopausal women assigned to testosterone therapy reported improvements in a variety of sexual domains vs. women assigned to placebo or estrogen, including frequency in satisfying events, arousal and orgasm, according to findings from a large meta-analysis of randomized controlled trials.

Susan Davis

“Our results suggest it is time to develop testosterone treatment tailored to postmenopausal women rather than treating them with higher concentrations formulated for men,” Susan Davis, MBBS, professor in the School of Public Health and Preventive Medicine at Monash University, Australia, said in a press release. “Nearly a third of women experience low sexual desire at midlife, with associated distress, but no approved testosterone formulation or product exists for them in any country, and there are no internationally agreed guidelines for testosterone use by women. Considering the benefits we found for women’s sex lives and personal well-being, new guidelines and new formulations are urgently needed.”

Davis and colleagues analyzed data from 36 randomized controlled trials with 8,480 premenopausal or postmenopausal women, assessing testosterone treatment of at least 12 weeks’ duration, including 13 studies that specifically recruited women with low sexual function. Testosterone was administered orally in 15 trials; via transdermal patch, cream or gel in 17 trials; and via transdermal spray, injection or subcutaneous implant in three trials. Studies were completed between 1990 and 2018. Primary outcomes were the effects of testosterone on sexual function, cardiometabolic variables, cognitive measures and musculoskeletal health.

Researchers found that, compared with placebo or a comparator (estrogen, with or without progestogen), testosterone increased sexual function including the frequency of satisfying sexual events (mean difference, 0.85; 95% CI, 0.52-1.18), sexual desire (standardized mean difference, 0.36; 95% CI, 0.22-0.5), pleasure (mean difference, 6.86; 95% CI, 5.19-8.52), arousal (standardized mean difference, 0.28; 95% CI, 0.21-0.35) and orgasm (standardized mean difference, 0.25; 95% CI, 0.18-0.32) in postmenopausal women.

Similarly, testosterone was associated with an increase in sexual responsiveness (standardized mean difference, 0.28; 95% CI, 0.21-0.35), improved self-image (mean difference, 5.64; 95% CI, 4.03-7.26), reduced sexual concerns (mean difference, 8.99; 95% CI, 6.9-11.08) and distress (standardized mean difference, –0.27; 95% CI, –0.36 to –0.17) in postmenopausal women.

“For premenopausal women, the only observed benefit was a reduction in sexually associated personal distress in one small study,” the researchers wrote.

Researchers also observed a rise in LDL cholesterol and reductions in total cholesterol, HDL cholesterol and triglycerides among women who received oral testosterone; however, these changes were not observed in women who received testosterone in transdermal patch or cream formulations.

An overall increase in weight was also observed with testosterone treatment, according to researchers. There were no effects reported for body composition, musculoskeletal variables or cognitive measures, although researchers noted that the number of women who contributed data for these outcomes was small.

In an analysis of pooled data from four studies — two with 538 postmenopausal women and two with 67 premenopausal women — researchers found that testosterone treatment did not modify depressive mood, irrespective of menopausal status. No benefits of testosterone were seen for psychological general well-being index scores from five studies in 810 postmenopausal women and in three studies with 224 premenopausal women.

Testosterone was associated with a significantly greater likelihood of reporting acne and hair growth; however, no serious adverse events were recorded.

“The beneficial effects for postmenopausal women shown in our study extend beyond simply increasing the number of times a month they have sex,” Davis said in the release. “Some women who have regular sexual encounters report dissatisfaction with their sexual function, so increasing their frequency of a positive sexual experience from never, or occasionally, to once or twice a month can improve self-image and reduce sexual concerns, and may improve overall well-being.”

The researchers noted that the absence of any approved testosterone formulations for women in any country is a “major treatment barrier.”

“This shortfall urgently needs to be addressed to eradicate the widespread practice of women being treated with male formulations and compounded products, resulting in testosterone concentrations several-fold greater than appropriate for women,” the researchers wrote. – by Regina Schaffer

Disclosures: The Australian National Health and Medical Research Council funded this study. Davis reports she has received honoraria from Besins Healthcare and Pfizer Australia and has served as a consultant for Besins Healthcare, Lawley Pharmaceuticals, Mayne Pharmaceuticals and Que Oncology.

Postmenopausal women assigned to testosterone therapy reported improvements in a variety of sexual domains vs. women assigned to placebo or estrogen, including frequency in satisfying events, arousal and orgasm, according to findings from a large meta-analysis of randomized controlled trials.

Susan Davis

“Our results suggest it is time to develop testosterone treatment tailored to postmenopausal women rather than treating them with higher concentrations formulated for men,” Susan Davis, MBBS, professor in the School of Public Health and Preventive Medicine at Monash University, Australia, said in a press release. “Nearly a third of women experience low sexual desire at midlife, with associated distress, but no approved testosterone formulation or product exists for them in any country, and there are no internationally agreed guidelines for testosterone use by women. Considering the benefits we found for women’s sex lives and personal well-being, new guidelines and new formulations are urgently needed.”

Davis and colleagues analyzed data from 36 randomized controlled trials with 8,480 premenopausal or postmenopausal women, assessing testosterone treatment of at least 12 weeks’ duration, including 13 studies that specifically recruited women with low sexual function. Testosterone was administered orally in 15 trials; via transdermal patch, cream or gel in 17 trials; and via transdermal spray, injection or subcutaneous implant in three trials. Studies were completed between 1990 and 2018. Primary outcomes were the effects of testosterone on sexual function, cardiometabolic variables, cognitive measures and musculoskeletal health.

Researchers found that, compared with placebo or a comparator (estrogen, with or without progestogen), testosterone increased sexual function including the frequency of satisfying sexual events (mean difference, 0.85; 95% CI, 0.52-1.18), sexual desire (standardized mean difference, 0.36; 95% CI, 0.22-0.5), pleasure (mean difference, 6.86; 95% CI, 5.19-8.52), arousal (standardized mean difference, 0.28; 95% CI, 0.21-0.35) and orgasm (standardized mean difference, 0.25; 95% CI, 0.18-0.32) in postmenopausal women.

Similarly, testosterone was associated with an increase in sexual responsiveness (standardized mean difference, 0.28; 95% CI, 0.21-0.35), improved self-image (mean difference, 5.64; 95% CI, 4.03-7.26), reduced sexual concerns (mean difference, 8.99; 95% CI, 6.9-11.08) and distress (standardized mean difference, –0.27; 95% CI, –0.36 to –0.17) in postmenopausal women.

“For premenopausal women, the only observed benefit was a reduction in sexually associated personal distress in one small study,” the researchers wrote.

Researchers also observed a rise in LDL cholesterol and reductions in total cholesterol, HDL cholesterol and triglycerides among women who received oral testosterone; however, these changes were not observed in women who received testosterone in transdermal patch or cream formulations.

PAGE BREAK

An overall increase in weight was also observed with testosterone treatment, according to researchers. There were no effects reported for body composition, musculoskeletal variables or cognitive measures, although researchers noted that the number of women who contributed data for these outcomes was small.

In an analysis of pooled data from four studies — two with 538 postmenopausal women and two with 67 premenopausal women — researchers found that testosterone treatment did not modify depressive mood, irrespective of menopausal status. No benefits of testosterone were seen for psychological general well-being index scores from five studies in 810 postmenopausal women and in three studies with 224 premenopausal women.

Testosterone was associated with a significantly greater likelihood of reporting acne and hair growth; however, no serious adverse events were recorded.

“The beneficial effects for postmenopausal women shown in our study extend beyond simply increasing the number of times a month they have sex,” Davis said in the release. “Some women who have regular sexual encounters report dissatisfaction with their sexual function, so increasing their frequency of a positive sexual experience from never, or occasionally, to once or twice a month can improve self-image and reduce sexual concerns, and may improve overall well-being.”

The researchers noted that the absence of any approved testosterone formulations for women in any country is a “major treatment barrier.”

“This shortfall urgently needs to be addressed to eradicate the widespread practice of women being treated with male formulations and compounded products, resulting in testosterone concentrations several-fold greater than appropriate for women,” the researchers wrote. – by Regina Schaffer

Disclosures: The Australian National Health and Medical Research Council funded this study. Davis reports she has received honoraria from Besins Healthcare and Pfizer Australia and has served as a consultant for Besins Healthcare, Lawley Pharmaceuticals, Mayne Pharmaceuticals and Que Oncology.

    Perspective
    Abraham Morgentaler

    Abraham Morgentaler

    This newly published systematic review and meta-analysis on androgen therapy in postmenopausal women by Islam and colleagues shows that treatment is effective at improving sexual desire and is safe. This is not news to clinicians experienced in management of female sexual dysfunction, who see the results of this treatment every day in their practices. Yet, there are no FDA-approved androgen products indicated for female use, so clinicians must prescribe formulations intended for men. In the face of high-level evidence of efficacy and safety, it is high time for the medical community to abandon its longstanding, unfounded bias against the use of androgens in women, and also in men.

    • Abraham Morgentaler, MD
    • Director, Mens Health, Boston
        Associate clinical professor of surgery, Beth Israel Deaconess Medical Center, Harvard Medical School
      President, The Androgen Society

    Disclosures: Morgentaler reports he has received payments from Acerus and Aytu BioScience.