Bioidentical Testosterone in Menopause: Latin American Caution

Bioidentical Testosterone in Menopause: New Latin American Statement Calls for Caution

Testosterone is increasingly discussed for menopause symptoms, particularly low sexual desire. Yet a new position statement from the Latin American Association of Gynecological Endocrinology (ALEG) argues that evidence for its use remains narrow and cautions specifically against non-standardized “bioidentical” formulas. This group of experts from eight countries analyzed decades of data to offer structured guidance where formal approvals are lacking.

Evidence Strictly Limits Testosterone to Diagnosed Sexual Desire Disorder

The ALEG statement, led by Dr. Sergio Pilnik of the Hospital Italiano de Buenos Aires, gives its highest grade recommendation (Grade A) to a single, clear indication: testosterone therapy should be limited to postmenopausal women with hypoactive sexual desire disorder (HSDD). This diagnosis requires a formal biopsychosocial evaluation by a healthcare provider, not simply a patient’s report of lower libido. HSDD is defined as a persistent lack of sexual fantasies and desire that causes personal distress.

“Many Latin American countries prescribe testosterone without specific guidelines,” the authors note, making it hard to identify who truly benefits. Their analysis of placebo-controlled studies and meta-analyses finds consistent evidence for improving sexual desire and function only in this specific group. They found insufficient evidence to recommend testosterone for improving energy, mood, cognitive function, or bone density in midlife women.

This narrow focus exists because the hormonal mechanisms for libido are complex. While estrogen supports vaginal blood flow and lubrication, testosterone receptors in the brain are linked to sexual motivation and arousal. Restoring testosterone to the physiological premenopausal range can target this pathway, but exceeding it carries risks without proven additional benefits for other symptoms.

Compounded “Bioidentical” Testosterone Poses Specific Risks

A significant warning in the document targets non-standardized formulations. The authors explicitly advise against subcutaneous pellets and compounded “bioidentical” testosterone due to “risks of supraphysiological dosing and insufficient evidence.”

“Bioidentical” typically refers to hormones chemically identical to those the body produces. However, when these are prepared in compounding pharmacies, the final product lacks the rigorous standardization and dose consistency of regulated pharmaceuticals. The statement points out that there are no androgenic products specifically approved for women in Latin America, leading to the adaptation of products designed for men or the use of these non-standardized compounds. This practice can result in dangerously high, supraphysiological blood levels of testosterone, increasing the potential for side effects like acne, hair loss, voice deepening, and potentially long-term cardiovascular risks.

For a deeper look at the evidence and risks surrounding these specific formulations, see our article Bioidentical Testosterone for Menopause: Evidence and Risks.

Transdermal Patches Preferred, Systemic DHEA Not Recommended

If therapy is warranted, the ALEG group recommends transdermal formulations as the preferred method. These gels or patches applied to the skin allow for steady absorption and easier dose adjustment to keep levels within the safe, premenopausal physiological window.

The statement also clearly distinguishes between different androgen therapies. It strongly advises against the systemic use of oral dehydroepiandrosterone (DHEA) for treating sexual symptoms (Grade A). DHEA is a precursor hormone the body converts into testosterone and estrogen. Taken orally, its conversion is unpredictable and can lead to unwanted hormonal effects. The authors note that evidence does not support its effectiveness for this purpose. However, they specify that vaginal DHEA (prasterone) is a different product with a localized action, and it is approved solely for treating the symptoms of genitourinary syndrome of menopause, such as vaginal dryness and pain during intercourse.

Monitoring is key. The guidelines suggest an initial follow-up within 3-6 weeks to check for symptom improvement and any adverse effects, with the goal of maintaining testosterone levels within the physiological range for premenopausal women.

Practical Steps for Women Considering Androgen Therapy

This position statement translates into several actionable steps for women experiencing symptoms. First, a thorough evaluation for HSDD is essential. This goes beyond a hormone test. “Routine serum measurements of testosterone or other androgens are not recommended for diagnosis,” the authors state. Blood levels do not reliably correlate with symptoms in women. However, they do recommend checking a baseline level before starting therapy to exclude the rare case of a woman who already has elevated testosterone.

Second, patients must receive clear counseling. ALEG stresses that women should be informed that testosterone therapy for female sexual dysfunction is an off-label use. They also emphasize that counseling should align with current clinical guidelines, setting realistic expectations about benefits and discussing potential risks.

Third, if a prescription is given, opting for a regulated transdermal product over a compounded pellet or cream may offer greater safety through dose consistency. You can read more about the recent guidelines shaping this approach in New Latin American Testosterone Guidelines Issued.

The ALEG statement acknowledges its limitations, being based on available evidence which is still evolving, particularly regarding long-term safety. It serves primarily to bring order and safety to a currently unregulated therapeutic area in many regions.

Conclusion

The Latin American expert statement clarifies that testosterone has a limited, evidence-based role in menopause care for diagnosed HSDD. It strongly cautions against non-standardized bioidentical formulas, advocating for regulated transdermal options and clear patient counseling on the off-label nature of this treatment.

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