Bioidentical Testosterone for Menopause: Evidence and Risks

Bioidentical Testosterone for Menopause: Experts Clarify the Evidence and Risks

A 2025 position statement from the Latin American Association of Gynecological Endocrinology (ALEG) provides clear, evidence-based guidance on androgen therapy for midlife and older women. The statement, developed by a team led by Silvina Pilnik of the Hospital Italiano de Buenos Aires, addresses widespread use of therapies like compounded “bioidentical” testosterone, where formal approval and standardized dosing are often lacking. It calls for a more structured, safer approach to treatment based on current science.

Specific Diagnosis Required: Not a General Tonic for Menopause

The ALEG panel gives its strongest recommendation, a Grade A, for a specific clinical path. Testosterone therapy should be reserved strictly for postmenopausal women with Hypoactive Sexual Desire Disorder (HSDD). This is not a simple case of lower libido. Diagnosis requires a formal biopsychosocial evaluation by a healthcare provider to rule out other causes like relationship stress, depression, or medication side effects.

“Routine serum measurements of testosterone or other androgens are not recommended for diagnosis,” the authors state. Hormone levels are a poor predictor of sexual function in women. Instead, the diagnosis is based on symptoms and clinical assessment. Checking a baseline blood level is only advised to ensure a woman does not already have abnormally high androgen concentrations before starting therapy.

Compounded “Bioidentical” Testosterone Carries Significant Risks

The position statement draws a sharp distinction between regulated and unregulated androgen products. In Latin America, and in many other regions, no testosterone product is formally approved for use in women. This regulatory gap leads to the off-label use of products formulated for men or to custom-mixed, compounded preparations often marketed as “bioidentical.”

These compounded subcutaneous pellets receive a clear warning. “They are not recommended due to risks of supraphysiological dosing and insufficient evidence,” the authors write. The term “supraphysiological” is key—it means these pellets can release hormone doses that skyrocket blood testosterone levels far beyond what the female body ever produces naturally. This poses unknown long-term risks for breast tissue, cardiovascular health, and metabolic function. The transdermal route—using a prescribed gel or patch—is strongly preferred because it allows for controlled, lower dosing that can more easily mimic natural premenopausal levels.

Systemic DHEA Lacks Evidence, But Vaginal Form Has a Place

The guidance also clarifies the role of dehydroepiandrosterone (DHEA), a precursor hormone the body converts into testosterone and estrogen. The panel’s conclusion is blunt: “Evidence to date does not support systemic DHEA as an effective treatment for sexual symptoms.” Taking oral DHEA supplements with the hope of boosting libido or energy is not backed by science (Grade A recommendation against).

However, the statement acknowledges a specific, localized use. Vaginal DHEA is approved for treating the genitourinary syndrome of menopause (GSM), which includes vaginal dryness, pain during intercourse, and urinary discomfort. This treatment acts directly on vaginal tissues to improve their health, separate from any systemic effect on desire. For more on evolving treatments for these symptoms, you can read about new treatments for vaginal atrophy.

Practical Steps for Considering Androgen Therapy

For women and clinicians considering this path, the ALEG statement outlines a practical framework. First, counseling must align with current clinical guidelines and include a frank discussion that testosterone use for female HSDD is an off-label prescription. Second, if therapy begins, monitoring is essential within 3 to 6 weeks to check testosterone levels and ensure they remain within the physiological range for a premenopausal woman. This helps minimize potential side effects like acne, hair growth, or voice changes.

The authors stress that this cautious approach is born from a lack of long-term safety data. Using non-standardized products, especially those designed for male physiology, introduces unnecessary risk. Their goal is to move practice away from indiscriminate use and toward a model where treatment is targeted, monitored, and based on the best available evidence, much like the structured approach recommended for hormone therapy after certain health conditions.

Conclusion

The ALEG position statement cuts through marketing claims about “bioidentical” androgen therapy. It affirms a limited, evidence-based role for testosterone in treating diagnosed HSDD, warns against risky compounded pellets, and dismisses systemic DHEA for sexual symptoms. This guidance promotes safer, more responsible care for women navigating complex treatment options during menopause.

Sources:
https://pubmed.ncbi.nlm.nih.gov/40919649/
https://pubmed.ncbi.nlm.nih.gov/40109076/
https://pubmed.ncbi.nlm.nih.gov/38980733/