Testosterone Therapy is Not Indicated for Women Based on Current Evidence
The available evidence does not support testosterone cream therapy for women with low testosterone levels, as all guidelines and FDA-approved formulations are specifically for men with confirmed hypogonadism. A testosterone level of 4 ng/dL in a 60-year-old woman falls below typical female reference ranges (approximately 15-70 ng/dL), but there are no established guidelines or FDA-approved testosterone preparations for treating low testosterone in women outside of specific research contexts.
Critical Evidence Gaps
All provided guidelines address testosterone replacement therapy exclusively in men, with specific diagnostic thresholds (typically <300 ng/dL) and treatment protocols that do not apply to women 1.
FDA-approved testosterone formulations are labeled only for male hypogonadism, with no approved indications for women 2. The FDA labeling for testosterone gel 1.62% specifies dosing for men starting at 40.5 mg daily, which would be inappropriate for women 2.
No guideline evidence exists in the provided materials for testosterone dosing in postmenopausal women, despite this being a common clinical question 1.
Why Standard Male Dosing Cannot Be Applied
The typical male starting doses range from 40.5-50 mg daily for transdermal preparations 1, 2, targeting testosterone levels of 350-750 ng/dL 1. These doses would result in supraphysiologic levels in women and carry significant risks including:
- Virilization (deepening voice, facial hair, clitoral enlargement)
- Cardiovascular effects
- Lipid abnormalities
- Hepatotoxicity
Clinical Approach in the Absence of Guidelines
Given the lack of evidence-based guidance, this patient should be referred to an endocrinologist or menopause specialist with expertise in female androgen therapy. If treatment is considered off-label:
Doses used in research settings for women are typically 1-10% of male doses (approximately 0.5-5 mg daily of testosterone cream), though this is not guideline-supported 3, 4.
Symptoms requiring treatment must be clearly documented, as low testosterone levels alone do not constitute an indication for therapy in women, unlike in men where both symptoms and low levels are required 1, 4.
Alternative causes of symptoms (fatigue, low libido, decreased muscle mass) must be thoroughly evaluated, including thyroid dysfunction, depression, medication effects, and other hormonal imbalances 3, 5.
Important Caveats
The absence of guideline support reflects genuine uncertainty about benefits and risks in women, not simply a gap in the literature search. The 2020 American College of Physicians guideline emphasizes that even in men, testosterone therapy should be limited to those with confirmed hypogonadism and specific symptoms, with careful risk-benefit discussions 1. This conservative approach is even more critical in women, where no approved formulations exist and long-term safety data are lacking 5, 6.
Any off-label use would require informed consent, discussion of unknown long-term risks, close monitoring of testosterone levels (targeting female physiologic ranges of 15-70 ng/dL), and regular assessment for virilization signs 1, 3.