The Androgen Society

The Androgen Society

March 22, 2019
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Testosterone improves libido, quality of life in women with low sexual desire

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NEW ORLEANS — Premenopausal and postmenopausal women reporting a persistent, low libido that profoundly impairs quality of life can experience an improvement in symptoms with transdermal testosterone, but clinicians must consider several important points before prescribing the therapy, according to a speaker at the Androgen Society annual meeting.

Sharon Parish

“Late-reproductive age and postmenopausal women who are symptomatic with distressing low sexual desire and other potentially related sexual dysfunctions may benefit from a trial of transdermal, evidence-based testosterone therapy, with a clear discussion about the risks and benefits,” Sharon Parish, MD, professor of medicine in clinical psychiatry and professor of clinical medicine at Weill Cornell Medical College, told Endocrine Today. “Use beyond 6 months is contingent on efficacy and the woman’s understanding about what we do know about risks and benefits.”

Among postmenopausal women and women who experienced surgical menopause or premature ovarian failure, studies show that low testosterone levels are closely correlated with reduced coital frequency and loss of sexual desire, and researchers have observed a positive relationship between free testosterone levels and the rating of sexual desire via interview questions, Parish said during her presentation. However, androgen levels in women decline over the age span, and that decline is most marked during the mid- to late 30s and 40s — typically, not correlating with the onset of menopause.

“Women often come to us in the late reproductive years with these symptoms, despite the fact that they are still cycling,” Parish said. “This represents a therapeutic question of when and how to use androgens, including testosterone.”

Whom to treat

Androgenic effects, Parish said, vary according to individual variations in the amount and activity of the enzymes 5-alpha reductase and aromatase, as well as individual differences in androgen-receptor response. A measurement of serum testosterone in women, she said, does not provide a specific measure of androgen tissue exposure or action. Additionally, there is no serum androgen level that defines female androgen insufficiency.

“There is no cutoff in clinical practice,” Parish said. “The measurement of all of these different androgens in women with low sexual function may not be informative, and we don’t use those levels to make a diagnosis of androgen insufficiency.”

The use of testosterone therapy for the treatment of sexual desire disorders is not based on an established link between symptoms and biochemistry, Parish said, but rather on clinical evidence that exogenous testosterone improves the most commonly reported sexual problems in women. These include measures of sexual desire and arousal, pleasure and overall satisfaction.

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“We do recommend, however, testing [testosterone level] prior to treatment,” Parish said. “My primary reason is to establish a baseline and have [a level] to follow, and to ensure that the testosterone is not high and I’m not missing another cause of distressing-acquired [hypoactive sexual desire disorder].”

Available safety data, while not conclusive, are reassuring with respect to cardiovascular, breast and endometrial outcomes, Parish said, with unblinded and extension trial data demonstrating a low rate of CV events and breast cancer in postmenopausal women at increased CV risk prescribed testosterone therapy. However, no randomized controlled trial has been of sufficient size or duration to provide adequate, evaluable data on the impact of testosterone on breast cancer risk, Parish said. Additionally, apart from studies of transgender men who receive much higher doses of testosterone vs. cisgender women, there are no available long-term data on testosterone treatment in premenopausal women, Parish said.

‘Dilemma of prescribing’

There is a “dilemma of prescribing” testosterone for women, Parish said, because any agent would be off-label. Only one country, Australia, has an approved 1% testosterone cream for women, she said.

In the U.S., options include FDA-approved products indicated for men, including 1% or 2% gel or an underarm solution typically at one-tenth of the men’s dose.

“People do use injections and pellets,” Parish said. “I don’t, because it doesn’t match what was used in the clinical trials, which was transdermal.”

The International Consultation on Sexual Medicine, the American College of Obstetricians and Gynecology, the North American Menopause Society, the International Menopause Society and the International Society for the Study of Women’s Sexual Health have all reaffirmed the use of testosterone therapy in women in the late reproductive years and beyond who report persistent, low libido that impairs quality of life. Any decision to use testosterone therapy should be individualized and include an informed-consent discussion regarding risks and benefits, Parish said. She noted that long-term safety data are lacking to use testosterone therapy beyond 6 months, and current data do not support its use in pre- and perimenopausal women.

“This is not an unstudied or undescribed recommendation,” Parish said. – by Regina Schaffer

Reference:

Parish S. How I treat women with testosterone deficiency. Presented at: The Androgen Society 2nd Annual Meeting; March 21-22, 2019; New Orleans.

Disclosure: Parish reports she has served as a consultant for AMAG Pharmaceuticals, Dare Bioscience, JDS Therapeutics, Procter & Gamble, Sprout, Strategic Science & Technologies and Therapeutics MD, served on an advisory board for AMAG Pharmaceuticals and has received writing support from AMAG, Sprout and Therapeutics MD.