ALEG on Androgens for Menopause: Bioidentical Risks Guide

Introduction

A new position statement from the Latin American Association of Gynecological Endocrinology (ALEG) focuses on the use of androgens like testosterone for women in midlife. Published in *Climacteric*, the document analyzes the best available evidence to clarify the role of these hormones in menopause care, offering specific warnings about certain “bioidentical” formulations.

Specific Recommendations and a “High-Grade” Warning

Led by Dr. Sabrina Pilnik and a multinational team, the ALEG statement makes a high-grade (Grade A) recommendation: testosterone therapy should be strictly limited to postmenopausal women with hypoactive sexual desire disorder. This condition is characterized by a persistent lack of interest in sexual activity that causes personal distress. Diagnosis requires a formal evaluation that considers biological, psychological, and social factors; it cannot be based on a simple blood test. The group emphasizes that routine measurement of testosterone or other androgens for diagnosis is not recommended, as levels do not reliably correlate with symptoms. However, they advise checking a baseline level before starting therapy to exclude patients who already have elevated concentrations, which could be worsened by treatment.

The authors note a critical gap in Latin American healthcare: no androgenic products are formally approved for use in women. This regulatory vacuum leads clinicians to prescribe medications designed and dosed for men or to turn to non-standardized compounded preparations. This practice increases the risk of administering incorrect, potentially harmful doses. Patients must be clearly informed that any testosterone prescription for this purpose is an off-label use.

Why Compounded “Bioidentical” Testosterone Raises Concern

The statement singles out subcutaneous pellets and compounded “bioidentical” testosterone for a specific warning, giving it a Grade C recommendation due to low-quality evidence and clear safety concerns. These custom-mixed formulations, often marketed as natural or bioidentical, are not subject to the same rigorous testing and standardization as pharmaceutical-grade medications. The primary risk is achieving supraphysiological dosing—levels far above the normal premenopausal range. Sustained high testosterone can lead to androgenic side effects like acne, hair growth in male patterns (hirsutism), voice deepening, and adverse effects on cholesterol levels.

“Monitoring should occur within 3-6 weeks,” the authors write, with the goal of keeping testosterone within the physiological range for premenopausal women. This tight control is difficult to achieve with long-acting pellets, which cannot be easily removed or adjusted once implanted. In contrast, transdermal formulations like gels or patches are preferred because their dose can be precisely controlled and stopped immediately if side effects occur. For more details on the risks of these specific formulations, our site explores them in Bioidentical Testosterone in Menopause: Latin American Caution.

DHEA: A Clear Distinction Between Systemic and Local Use

The statement draws a sharp line between two uses of dehydroepiandrosterone (DHEA), a precursor hormone the body converts into androgens and estrogens. For systemic treatment of symptoms like low libido or fatigue, oral DHEA supplements receive a high-grade recommendation (Grade A) *against* their use. “Evidence to date does not support systemic DHEA as an effective treatment for sexual symptoms,” the authors conclude.

However, vaginal DHEA is recognized as a valid and approved treatment for the genitourinary syndrome of menopause (GSM), which includes vaginal dryness, pain during intercourse, and urinary discomfort. When applied locally, DHEA acts directly on vaginal tissues, providing estrogen-like benefits with minimal absorption into the bloodstream. This targeted approach is effective for its specific purpose but is not a solution for broader menopausal concerns. Other non-hormonal options for related symptoms are also being researched, as discussed in New Treatments for Vaginal Atrophy & Menopause Symptoms.

Navigating Treatment and a Call for Standardization

For women and their clinicians, the ALEG position statement provides a clear, evidence-based framework. The first step is a comprehensive clinical assessment, not a lab test. If HSDD is diagnosed and other causes are ruled out, a trial of testosterone may be considered, starting with the safest available formulation—a transdermal product. The initial dose should be the lowest possible, with close monitoring for efficacy and side effects within weeks. The objective is symptom relief, not achieving a specific testosterone number.

The authors acknowledge a significant limitation: long-term safety data on testosterone therapy in women, particularly beyond two years, remains sparse. This uncertainty reinforces the need for careful patient selection and periodic re-evaluation of the treatment’s ongoing necessity. The ultimate goal of the statement, according to the authors, is to promote good medical practice in a region lacking formal guidelines, protecting women from inappropriate or unsafe treatments. This aligns with other expert reviews on the topic, such as the analysis in Testosterone in Midlife Women: ALEG Position Statement.

Conclusion

The ALEG position statement clarifies that androgen therapy in menopause has a narrow, well-defined role. Testosterone is a potential treatment only for diagnosed HSDD, not a general tonic for aging. The strongest warnings apply to non-standard compounded products, which carry unquantified risks. Effective treatment requires precise dosing, close monitoring, and a clear understanding that the benefits are specific, not systemic.

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