New Latin American Testosterone Guidelines Issued

Latin American Expert Group Issues Strict New Guidelines on Testosterone Therapy

For midlife and older women in Latin America, accessing testosterone therapy has been an unregulated, often confusing process. A new position statement from the Latin American Association of Gynecological Endocrinology aims to change that. Their analysis of global evidence provides clear, restrictive recommendations for using androgens, directly advising against common unregulated practices.

Sexual Desire Disorder is the Sole Established Indication

The ALEG panel, led by Dr. Sandra Pilnik of the Hospital Italiano de Buenos Aires, assigned their strongest “Grade A” recommendation to a single, narrow use case. Testosterone therapy for postmenopausal women should be limited solely to those with hypoactive sexual desire disorder (HSDD). This diagnosis is not based on a simple blood test or a fleeting feeling. It requires a formal biopsychosocial evaluation by a clinician to confirm a persistent lack of sexual fantasies and desire causing personal distress.

This specificity directly counters a common clinical practice: prescribing testosterone for fatigue, low energy, or a vague sense of “well-being.” The group’s analysis found insufficient high-quality evidence to support testosterone’s effectiveness for these broader concerns. The statement also clarifies that oral dehydroepiandrosterone (DHEA) taken systemically is not advised for treating sexual symptoms, aligning with other international bodies. Vaginal DHEA, however, retains its separate, approved role for treating genitourinary syndrome of menopause.

Compounded “Bioidentical” Testosterone Pellets are Not Recommended

The position statement makes a critical distinction between pharmaceutical-grade hormones and compounded products. It explicitly advises against subcutaneous pellets and compounded “bioidentical” testosterone. The reason is risk. These custom-made products, often marketed as natural or tailored, are not standardized and can lead to supraphysiological dosing—levels far higher than the body would ever produce naturally.

“The risk of supraphysiological dosing is a primary concern,” the authors note. Unlike a transdermal gel where the dose can be adjusted or stopped immediately, a pellet implanted under the skin releases testosterone for months and cannot be removed. This can result in prolonged, excessively high levels, potentially increasing the risk of androgenic side effects like acne, hair growth, and voice changes. The statement points to a lack of sufficient evidence supporting the safety and efficacy of these formulations, especially compared to regulated transdermal options.

Monitoring Strategy: Focus on Clinical Response, Not a Lab Number

A significant shift recommended by the Latin American experts is in how therapy is monitored. They state that routine measurement of serum testosterone or other androgens is not recommended for diagnosis. This challenges the common belief that a “low T” lab result alone justifies treatment. Instead, the clinical diagnosis of HSDD is paramount.

However, once the decision to treat is made, a baseline testosterone level is necessary. This pre-treatment test serves one main purpose: to exclude women who already have elevated concentrations, for whom adding more testosterone would be unsafe. After initiating therapy, follow-up should occur within 3-6 weeks. The goal of monitoring is to ensure the dose keeps testosterone within the premenopausal physiological range, preventing the dangers of supraphysiological levels while assessing whether the patient’s symptoms are improving.

Navigating an Unregulated Landscape Requires Informed Consent

The position statement frankly acknowledges a major systemic problem: in many Latin American countries, there are no androgenic products specifically approved for women. This regulatory gap forces clinicians and patients into using products designed and certified for men, requiring careful dose adjustments, or resorting to non-standardized compounded preparations. Both scenarios increase risk.

Given this context, the ALEG’s conclusion is firm. Women must receive counseling aligned with current clinical guidelines, and the off-label nature of testosterone use must be explicitly discussed. Patients should understand that while it can be an effective treatment for HSDD, it is not a general wellness tonic. The path forward, the group argues, relies on education and adopting the standardized, evidence-based protocols they outline to improve safety and outcomes across the region.

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