Topical testosterone formulations needed to treat sexual dysfunction in postmenopausal women

Non-oral formulations of testosterone are urgently needed for the treatment of sexual dysfunction in postmenopausal women, Victorian clinicians say

Monash University researchers say their systematic review provides robust evidence that testosterone treatment can significantly improve sexual wellbeing for postmenopausal women.

The benefits include improved sexual desire, function and pleasure, together with reduced concerns and distress about sex, according to lead author Professor Susan Davis, an endocrinologist and program director for the university’s Women’s Health Research Program.

But women need much lower doses of testosterone than delivered by the oral formulations designed for men and yet there are no transdermal patches or creams formulations approved that would help avoid the adverse lipid effects of oral formulations, they wrote in the Lancet Diabetes and Endocrinology.

“Our results suggest it is time to develop testosterone treatment tailored to postmenopausal women rather than treating them with higher concentrations formulated for men,” said Professor Davis.

“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 wellbeing, new guidelines and new formulations are urgently needed.”

The systematic review and meta-analysis of testosterone treatment covered 36 randomised trials involving 8,480 women. It found that compared to placebo or oestrogen treatment, testosterone significantly increased  sexual function and frequency, and reduced sexual concerns and distress for postmenopausal women.

“The beneficial effects for postmenopausal women shown in our study extend beyond simply increasing the number of times a month they have sex,” said Professor Davis.

“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 wellbeing.”

The data did not support use of testosterone in premenopausal women, and found no beneficial effects on cognitive measures, bone mineral density, body composition or muscle strength. No benefits were seen for depressive mood irrespective of menopausal status or in psychological wellbeing.

Adverse side effects of non-oral formulations appear to be restricted to mild androgenic effects including modest weight gain, mild acne and increased hair growth, but not alopecia, voice deepening, or cliteromegaly.

“Therefore, women who initiate testosterone treatment must be warned that these side-effects can occur and counselled against applying more than the prescribed dose,” the authors wrote.

Only limited data were available for breast and endometrial cancer risk and further research is needed to clarify the effects, they added.

In a linked commentary, Dr Rossella Nappi from the University of Pavia, Italy, cautioned that there was a need for long-term studies to address potential risks of testosterone such as cardiovascular events  in women.

“There is an urgent need in the area of sexual medicine to ensure gender equality in treating effectively those women with female sexual dysfunction clearly related to hypoandrogenic states. However, products specifically approved in women should become available to achieve this goal; at present, only male formulations are available, with clinicians adjusting the dose to the female circulating testosterone range.”

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