A Latin American statement narrows testosterone for women to one indication

Testosterone is prescribed to midlife women in many countries for symptoms ranging from low libido to fatigue to "hormonal optimisation," largely without a licensed product for the indication. A position statement from the Latin American Association of Gynecological Endocrinology, published in Climacteric on September 8, addresses that gap directly for the region [s1].

Its central claim is restrictive. Testosterone therapy for postmenopausal women should be limited to those with hypoactive sexual desire disorder confirmed through a formal biopsychosocial evaluation — a recommendation the statement grades A, high certainty [s1].

Why a regional statement

The statement's stated motivation is that in many Latin American countries testosterone is prescribed without specific guidelines, making it difficult to identify which patients might benefit [s1]. Evidence on benefits and risks remains limited, and no clearly established indications exist [s1].

The statement was assembled from Cochrane reviews, placebo-controlled studies, meta-analyses, international guidelines, consensus statements, and government regulations published from 2000 onwards [s1].

This is expert consensus over an existing evidence base, not new data. It should be read as such.

The recommendations, and their grading

The grading matters more than usual here, because the statement itself marks most of its guidance as resting on low-certainty evidence [s1]:

• Testosterone limited to hypoactive sexual desire disorder, confirmed by formal biopsychosocial evaluation — Grade A, high [s1].
• Routine serum measurement of testosterone or other androgens is not recommended for diagnosis — Grade A, high [s1].
• Baseline levels should nonetheless be checked before therapy, to exclude elevated concentrations — Grade C, low [s1].
• Monitoring within three to six weeks, keeping testosterone within the premenopausal physiological range — Grade C, low [s1].
• Transdermal formulations preferred; subcutaneous pellets and compounded "bioidentical" testosterone not recommended, because of risks of supraphysiological dosing and insufficient evidence — Grade C, low [s1].
• Oral dehydroepiandrosterone is not advised systemically — Grade A, high [s1]. Vaginal DHEA is approved only for genitourinary syndrome of menopause [s1].

The statement's conclusion adds that women must be informed before starting that the use is off-label, and that evidence to date does not support systemic DHEA as an effective treatment for sexual symptoms [s1].

The tension inside the guidance

Two recommendations sit awkwardly together. Serum androgen measurement is explicitly not recommended for diagnosis (Grade A), yet baseline levels should be checked to exclude elevated concentrations, and treatment monitored to keep levels in the premenopausal range (both Grade C) [s1]. The distinction being drawn is between using a blood level to decide who has the condition — which the evidence does not support — and using it as a safety boundary once treatment is under way. That is a coherent distinction, but it is one clinicians and patients routinely collapse, and the statement's own grading concedes the safety-monitoring half rests on low-certainty evidence.

How it compares with the global position

The 2019 Global Consensus Position Statement on the Use of Testosterone Therapy for Women was endorsed by a long list of societies including the International Menopause Society, the Endocrine Society, the European Menopause and Andropause Society, the North American Menopause Society, the Federación Latinoamericana de Sociedades de Climaterio y Menopausia, and the Royal College of Obstetricians and Gynaecologists [s2].

The ALEG statement does not depart from that global framework so much as apply it to a setting where prescribing has run ahead of it. Its distinctive content is regional: the observation that testosterone is being prescribed without guidelines across many Latin American countries, and the explicit warning against compounded and pellet formulations [s1], which are the products most likely to deliver supraphysiological doses.

The limits of a consensus document

A position statement cannot generate evidence it does not have. The statement notes that evidence regarding benefits and risks remains limited [s1], and the reason is structural: there is no licensed female testosterone product in most markets, so there is no commercial sponsor for the long-term trials that would settle the safety question. The available randomised evidence is predominantly short-term and focused on sexual function endpoints.

That leaves the most consequential questions — cardiovascular and breast safety over years of use — unaddressed by trials, and unaddressed by this statement.

What to watch

Whether any regulator licenses a female-specific testosterone formulation, which would change the off-label framing entirely; whether long-term safety data accumulate from registries; and whether compounded and pellet prescribing in the region responds to guidance that names it directly.

This article describes a professional society position statement and is informational only. It is not medical advice and does not recommend any hormone, dose, or formulation. Testosterone use in women is off-label in most jurisdictions and is a matter for a prescribing clinician.

Sources

• [s1] Pilnik S, Belardo A, Marchesan LB, Camero-Lascano A, Acuña-San Martín M, Elizalde-Cremonte A, Ojeda E, Manzur A, Chedraui P, Androgen therapy in midlife and older women: a position statement of the Latin American Association of Gynecological Endocrinology (ALEG), Climacteric, 2025;28:529-536, published online 2025-09-08.
• [s2] Davis SR, Baber R, Panay N, et al., Global Consensus Position Statement on the Use of Testosterone Therapy for Women, The Journal of Clinical Endocrinology & Metabolism, 2019;104:4660-4666, published online 2019-09-02.