Understanding the Rise of Testosterone Therapy in Menopause Treatment

As more women approach menopause, they encounter a range of treatments claiming to alleviate symptoms from hot flashes to cognitive difficulties. Among these, testosterone therapy is gaining traction, despite a notable lack of scientific endorsement for its use during menopause.

A recent study highlighted that more than 90,000 off-label testosterone prescriptions were issued to women in the U.S. in 2025, with a significant percentage for those aged 45 to 64. This represents a 58.7% rise from the previous year, pointing to a growing trend in off-label use of testosterone among menopausal women, even though the FDA has not approved this treatment for any menopausal stages.

Testosterone Dynamics and Menopause Misconceptions

Interestingly, while testosterone is often labeled a "male hormone," it also plays a role in women's health, albeit at lower levels. A common misconception is that women experience a significant drop in testosterone leading to menopause. In actuality, levels of this hormone decrease gradually from age 20 until about 60, before showing a slight uptick past that age. Clinical research indicates that menopause, which generally occurs around age 51 or 52, does not correlate with an abrupt decline in testosterone; rather, it results primarily from falling estrogen and progesterone levels that drive menopause symptoms.

Dr. Susan Davis, an endocrinology professor and head of the Women's Health Research Program at Monash University, emphasizes that the symptoms often associated with menopause, such as fatigue and mood changes, are not related to androgen deficiency. Studies have failed to demonstrate a direct benefit of testosterone for addressing common menopausal symptoms like cognitive fog or mood changes. "It's incorrect to say fatigue or low mood are symptoms of androgen deficiency," Dr. Davis asserts.

The FDA's recent workshop on this topic echoed these concerns, noting the necessity for more comprehensive evidence to evaluate testosterone therapy as a valid treatment for menopause-related issues.

The Specifics of Testosterone’s Impact on Sexual Desire

One area where testosterone has shown potential is in the treatment of hypoactive sexual desire disorder (HSDD) among postmenopausal women, where a lack of sexual desire causes significant distress. Although some studies have found that testosterone can increase the frequency of satisfying sexual events by about 0.85 per month when administered via skin patches, experts like Dr. Nanette Santoro of the University of Colorado caution that this increase isn’t particularly impressive. While anecdotal reports of enhanced sexual experiences abound, rigorous scientific validation is still lacking.

Currently, testosterone treatments for HSDD in menopausal women do not have FDA approval, whereas other options, such as flibanserin, are established for HSDD in pre- and postmenopausal women under 65 years of age.

Challenges with Placebo Effects in Studies

Compounding the uncertainty surrounding testosterone therapy is the placebo effect, where participants report improvements in symptoms despite receiving inactive treatments. Dr. Davis highlights that nearly one-third of women in her studies experienced symptom relief while on placebo, presenting challenges in discerning the actual efficacy of testosterone treatments.

To address such gaps in data, the ESTEEM trial, conducted by the U.K. National Institute for Health and Care Research, aims to recruit a significant number of menopausal women to examine the effects of testosterone cream on quality of life. Expected to complete by 2028, this trial hopes to provide clearer insights into whether testosterone can reliably enhance various menopause-related symptoms.

Potential Hazards of Off-Label Testosterone Use

The discourse surrounding testosterone therapy is further complicated by safety concerns, particularly since most testosterone formulations are not specifically calibrated for women. Only a handful of countries, including Australia, South Africa, New Zealand, and the U.K., offer testosterone creams that are safely dosed for females, particularly targeting those with HSDD.

In contrast, American practitioners frequently prescribe male-dosage testosterone products, leading to potential risks associated with inappropriate dosing. Dr. Santoro warns that excessive testosterone can induce masculinizing effects in women, such as clitoral enlargement or hair loss, raising concerns over the unregulated use of high-dosage formulations.

Beyond physical side effects, the long-term cardiovascular implications and breast cancer risks associated with elevated testosterone levels remain inadequately understood. Lower dosages may result in mild acne or skin oiliness, typically deemed acceptable; however, higher doses present significant concerns.

Ultimately, off-label testosterone use in the U.S. introduces complications, as neither a thorough evaluation of safety nor efficacy has been completed by the FDA. There’s a stark difference between how testosterone is metabolized in men versus women, emphasizing the need for caution in treatment decisions.

Dr. Davis advocates for comprehensive care that transcends medication, highlighting the importance of assessing lifestyle factors such as diet and exercise while addressing societal pressures surrounding menopause. With the complexities of testosterone therapy, she advises a cautious stance: "Be skeptical of those offering simple solutions to complex problems."

This landscape requires careful navigation, reflecting the ongoing need for informed discussions and rigorous study as women explore their options during menopause.