Testosterone Therapy for Women with Low Testosterone
There is no FDA-approved testosterone product specifically formulated for women with low testosterone, and current guidelines focus exclusively on male hypogonadism. 1
Critical Context: Off-Label Use in Women
The available evidence and guidelines address testosterone therapy almost exclusively in men. The FDA-approved testosterone products (enanthate, cypionate, undecanoate) are indicated only for male hypogonadism and metastatic breast cancer in postmenopausal women—not for treating low testosterone in women. 1
Limited Evidence for Women
When testosterone is used off-label in women, the formulations and dosing differ substantially from male protocols:
Testosterone undecanoate oral formulations have been studied in postmenopausal women at 40 mg daily, showing rapid absorption with peak testosterone and dihydrotestosterone levels occurring 2-4 hours after administration. 2
Individual variations in absorption are considerable, and regular monitoring of testosterone serum levels is essential to avoid overtreatment in women. 2
The same oral testosterone undecanoate has been used in female-to-male transgender individuals at much higher doses (typically administered every 3 months intramuscularly), producing masculinizing effects including cessation of menstrual cycles, facial/body hair growth, voice deepening, and clitoromegaly. 3, 4
Safety Concerns Specific to Women
The AUA guidelines explicitly warn that women and children are at highest risk for adverse events from testosterone exposure, including virilization, precocious puberty, and hyperandrogenism. 5
Topical testosterone preparations carry significant risk of transference to women and children through skin contact with unwashed or uncovered application areas. 5
The FDA includes medication guides with topical testosterone preparations specifically warning about these risks. 5
Clinical Reality and Recommendations
In clinical practice, when testosterone is prescribed off-label for women with documented low testosterone and symptoms:
Compounded testosterone creams or gels are most commonly used, though the AUA guidelines note that compounded preparations operate without direct FDA oversight, resulting in considerable variation in potency and quality between pharmacies. 5
Commercially manufactured testosterone products should be prescribed rather than compounded testosterone when possible, though this recommendation was made in the context of male therapy. 5
Doses used in women are typically 1/10th to 1/20th of male replacement doses, though specific dosing guidelines for women with low testosterone (outside of gender-affirming therapy) are not established in the provided evidence.
Important Caveats
The evidence base for testosterone therapy in cisgender women with low testosterone is extremely limited. The guidelines reviewed focus on:
- Male hypogonadism (primary indication) 5, 6
- Metastatic breast cancer in postmenopausal women (FDA-approved but narrow indication) 1
- Gender-affirming therapy for transgender men (specialized use) 3, 4
No guideline-level evidence addresses the routine treatment of low testosterone in cisgender women for symptoms such as decreased libido or fatigue. This represents a significant gap in the medical literature, and any use in this population remains off-label without established safety or efficacy data from high-quality trials.