Testosterone in Midlife Women: ALEG Position Statement

Introduction

Testosterone use in midlife women is expanding, yet clear guidance and approved products are often lacking. A new position statement from the Latin American Association of Gynecological Endocrinology (ALEG) examines the evidence, calling for structured, cautious application of androgen therapy, particularly for compounded or “bioidentical” formulations.

Only One Clear Indication for Testosterone: Confirmed HSDD

The Latin American panel, led by Dr. Silvina Pilnik of the Hospital Italiano de Buenos Aires, assigned its highest-grade recommendation (Grade A) to a specific scenario. Testosterone therapy should be limited to postmenopausal women with hypoactive sexual desire disorder (HSDD). This diagnosis requires more than a simple complaint of low libido; it necessitates a formal biopsychosocial evaluation to confirm persistent, distressing lack of sexual desire not explained by other medical issues, relationship problems, or medications.

The authors emphasize that HSDD is the sole condition with substantial evidence supporting testosterone’s benefit. They found no high-quality evidence to support its use for general fatigue, mood changes, or cognitive symptoms often reported during menopause. This narrow focus aims to prevent inappropriate prescribing for symptoms that may not respond to androgens.

Warning Against Compounded “Bioidentical” Testosterone

A central caution in the statement targets custom-mixed, or compounded, testosterone products marketed as “bioidentical.” The panel does not recommend subcutaneous pellets or other compounded testosterone formulations. Their position, graded as a “C” recommendation based on lower-quality evidence, cites significant risks.

“These formulations can lead to supraphysiological [above normal] dosing and lack sufficient evidence for safety and efficacy in women,” the authors write. Without standardised manufacturing and dosing, compounded products can deliver unpredictable hormone levels, potentially increasing the risk of androgenic side effects like acne, hair growth, and voice changes. The panel’s stance aligns with broader concerns about the lack of regulatory oversight for these preparations. For readers interested in this specific risk, a related article details the caution surrounding bioidentical formulas.

Transdermal Patches Preferred, Oral DHEA Discouraged

For women with confirmed HSDD who proceed with treatment, the ALEG statement provides practical guidance on administration. The authors recommend transdermal formulations—typically gels or patches—as the preferred method. These allow for steady absorption and easier dose adjustment to keep serum testosterone within the premenopausal physiological range.

Conversely, they strongly advise 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. The panel concluded that current evidence does not support oral DHEA as an effective treatment for conditions like HSDD. An exception is made for vaginal DHEA, which is approved specifically for treating the genitourinary syndrome of menopause (vaginal dryness and pain).

Navigating an “Off-Label” Landscape with Careful Monitoring

The reality for clinicians and patients in Latin America, and many other regions, is that no androgen product is formally approved for use in women. This forces the use of products designed for men or non-standardised compounds. “Patients must be informed that its use is off-label,” the statement explicitly concludes.

Monitoring is a critical component of safe use. The panel suggests the first follow-up should occur 3 to 6 weeks after starting therapy. The goal is to check for clinical improvement in symptoms and monitor for side effects, with an aim to maintain testosterone levels within a normal premenopausal range. They stress that while blood tests should not be used to diagnose a need for testosterone, checking a baseline level before therapy is important to avoid treating women who already have high androgen concentrations.

This careful, evidence-based approach is designed to balance potential benefit against known risks. It reflects a growing consensus that hormonal therapies, while valuable for specific issues, require precise application. This is similar to the precision needed when considering hormone therapy after certain medical histories, where individual risk dictates the path forward.

Conclusion

The ALEG position statement clarifies that testosterone therapy is not a broad remedy for menopause but a targeted intervention for confirmed HSDD. It calls for disciplined diagnosis, cautions against non-standard compounded products, and insists on patient awareness of its off-label status. This framework promotes safety in a therapeutic area lacking formal approvals.

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