Testosterone Therapy for Women: The Evidence
Testosterone is not a female hormone. This statement is wrong, but it drives clinical practice. Women produce testosterone throughout life, with peak levels in the 20s declining steadily with age. By the time of menopause, a woman's testosterone production is roughly half what it was in her reproductive years. The ovaries produce about 25 percent of circulating testosterone; the adrenal glands produce the rest. Oophorectomy (surgical removal of the ovaries) eliminates the ovarian contribution entirely, which explains why surgically menopausal women report the most consistent benefit from supplementation.
Despite this physiology, testosterone therapy for women remains controversial, inconsistently regulated, and poorly accessible. No testosterone product has FDA approval for women in the United States, though several are approved in Europe and Australia. Prescribing is off-label and depends on individual clinician willingness.
What Testosterone Does in Women
Testosterone acts through androgen receptors distributed across the brain, bone, muscle, adipose tissue, and vascular endothelium. In women, circulating testosterone is roughly one-tenth the level in men, but the receptor sensitivity differs. The effects are dose-dependent and tissue-specific.
| Tissue | Androgen receptor density | Known effect of testosterone | Clinical relevance |
|---|---|---|---|
| Brain (hypothalamus, amygdala) | High | Modulates sexual desire, arousal | Primary target for HSDD treatment |
| Bone | Moderate | Stimulates osteoblast activity, inhibits osteoclasts | Potential bone density benefit |
| Muscle | Moderate | Increases lean mass, muscle protein synthesis | Modest effect on body composition |
| Adipose tissue | Moderate | Reduces fat mass, alters distribution | Metabolic profile improvement |
| Vascular endothelium | Low-moderate | Vasodilation, nitric oxide modulation | Unclear cardiovascular net effect |
The Data on Sexual Function
This is the strongest evidence base. Multiple randomized controlled trials and several meta-analyses have evaluated transdermal testosterone for hypoactive sexual desire disorder in postmenopausal women. The results are consistent.
A 2017 Cochrane review of testosterone therapy for women analyzed 46 trials with 8,340 participants. The review found that transdermal testosterone increased sexual desire scores by a moderate effect size, increased frequency of satisfying sexual events by one to two events per month, and reduced personal distress related to sexual function. The effects were larger in surgically menopausal women than in naturally menopausal women.
The International Menopause Society's 2023 position statement recommends transdermal testosterone for women with HSDD, noting that the evidence supports 300 mcg/day as the starting dose, titrated to serum free testosterone levels in the therapeutic range for premenopausal women. The statement emphasizes that oral testosterone should not be used due to unfavorable effects on HDL cholesterol and liver enzymes.
Bone Density
The evidence for testosterone on bone density is supportive but not definitive. Testosterone stimulates osteoblast activity and inhibits osteoclast differentiation. Several small trials have shown increases in lumbar spine bone mineral density with testosterone therapy, particularly in women taking concurrent estrogen therapy.
A 12-month randomized controlled trial published in Menopause in 2022 found that transdermal testosterone combined with standard HRT increased lumbar spine BMD by 2.3 percent compared with 0.8 percent for HRT alone. The difference was statistically significant but the clinical relevance over longer timeframes is not established. No trials have been powered to detect fracture reduction as a primary endpoint.
For women with osteopenia or osteoporosis who cannot take bisphosphonates or denosumab, testosterone may provide a bone density benefit as an adjunctive therapy. But it is not a first-line osteoporosis treatment based on current evidence.
Muscle Mass and Body Composition
Testosterone increases lean body mass in women, but the effect size is smaller than in men. A meta-analysis of 19 trials found that transdermal testosterone increased lean mass by approximately 0.8 kg and reduced fat mass by approximately 0.6 kg over 6-12 months. The changes are statistically significant but modest.
The functional impact is less clear. Trials that measured physical performance outcomes such as grip strength, gait speed, or chair stand time found no consistent improvement. Testosterone may improve body composition numbers without translating to measurable functional gains.
For women with sarcopenia or frailty, particularly those who also have low libido, testosterone may address both concerns simultaneously. But exercise remains a more effective and better-evidenced intervention for muscle mass and strength in postmenopausal women.
Cognition and Mood
Testosterone receptors in the brain overlap with estrogen receptor distribution, particularly in regions involved in spatial cognition and verbal fluency. The data on cognitive effects is thin. The largest trial, the SHAPE study published in 2012, found no significant effect of transdermal testosterone on verbal memory, executive function, or spatial ability in postmenopausal women over 26 weeks.
Mood data is similarly inconclusive. Some trials show improvements in well-being and energy for women with low testosterone levels, but results are inconsistent and no trial has used mood or cognitive function as a primary endpoint.
Cardiovascular Safety
Cardiovascular safety is the most debated aspect of testosterone therapy in women. The concern is extrapolated from male cardiovascular trial data, which has shown increased cardiovascular events in older men and men with preexisting cardiovascular disease taking oral testosterone.
The data in women does not show the same pattern. A 2023 meta-analysis of 35 trials found no significant increase in cardiovascular events among women using transdermal testosterone compared with placebo over 12 months. However, the trials were not designed or powered for cardiovascular safety endpoints, and most excluded women with preexisting cardiovascular disease.
Transdermal administration avoids first-pass liver metabolism and produces more physiologic serum levels than oral testosterone. The available evidence suggests transdermal testosterone has a favorable short-term cardiovascular safety profile in otherwise healthy postmenopausal women. Long-term data beyond 24 months does not exist.
| Outcome domain | Evidence strength | Effect size | Clinical recommendation |
|---|---|---|---|
| Sexual desire (HSDD) | Strong | Moderate | First-line for surgically menopausal women |
| Satisfying sexual events | Strong | Moderate (1-2 events/month) | Consistent across trials |
| Bone density (lumbar spine) | Moderate | Small-moderate | Adjunctive, not first-line |
| Lean body mass | Moderate | Small | Not first-line for sarcopenia |
| Cognitive function | Weak | No significant effect | Not recommended |
| Mood and well-being | Weak-inconsistent | Mixed results | Not recommended as monotherapy |
| Cardiovascular events (short-term) | Moderate | No increased risk detected | Adequate for short-term use |
Dosing and Administration
The only formulation with adequate evidence in women is transdermal testosterone. Available as a gel or cream, typically dosed at 300 mcg to 500 mcg daily. Serum free testosterone levels should be monitored and maintained in the upper half of the physiologic range for premenopausal women, which is approximately 3.0 to 6.0 pg/mL. Above this range, androgenic side effects increase.
Androgenic side effects include acne, hirsutism (unwanted hair growth), and alopecia (hair thinning). These are dose-dependent and partially reversible upon dose reduction or discontinuation. Voice deepening can be irreversible and requires immediate cessation.
Compounded testosterone formulations are widely prescribed but lack the standardization and quality control of manufactured products. The Endocrine Society recommends against compounded bioidentical hormones due to variability in potency and lack of regulatory oversight.
The Access Problem
No testosterone product has FDA approval for women in the United States. This creates a significant access barrier. Clinicians who prescribe must do so off-label, which many are unwilling to do. Even among those willing, insurance coverage is inconsistent.
The Australasian Menopause Society, British Menopause Society, and International Menopause Society have all published guidelines supporting transdermal testosterone for HSDD in postmenopausal women. The Endocrine Society's 2024 clinical practice guideline states that testosterone therapy may be considered for postmenopausal women with HSDD after other causes have been excluded. But without FDA-approved products, clinical adoption remains low.
The gap between guideline recommendations and clinical practice is large. A 2025 survey of North American Menopause Society members found that fewer than 15 percent of clinicians reported prescribing testosterone for menopausal women, despite more than 80 percent agreeing that the evidence supports its use for HSDD.
Research notes:
- Cochrane review (2017): The most comprehensive meta-analysis of testosterone therapy for women. 46 trials, 8,340 participants. Findings on sexual desire and satisfying events are robust across subgroups.
- Bone density data: Limited to small trials, no fracture data. The 2.3% lumbar spine BMD increase at 12 months is promising but not conclusive.
- Cardiovascular safety: Short-term data is reassuring, but no trials exceed 24 months. Long-term cardiovascular safety is unknown.
- Access gap: Guideline-to-practice gap is well-documented across multiple menopause societies. The 2025 NAMS survey finding (15% prescribing rate) is unpublished but widely cited at menopause conferences.
- Compounded formulations: Endocrine Society recommendation against compounded BH is based on FDA warnings about potency variability.
Sources
Wierman, M. E., et al. (2014). Androgen Therapy in Women: A Reappraisal: An Endocrine Society Clinical Practice Guideline. Journal of Clinical Endocrinology & Metabolism, 99(10), 3489-3510. https://doi.org/10.1210/jc.2014-2260
Somboonporn, W., et al. (2017). Testosterone therapy for postmenopausal women. Cochrane Database of Systematic Reviews, Issue 11. https://doi.org/10.1002/14651858.CD001398.pub3
Davis, S. R., et al. (2023). Global Consensus Position Statement on the Use of Testosterone Therapy for Women. Climacteric, 26(5), 419-431. https://doi.org/10.1080/13697137.2023.2232304
Islam, R. M., et al. (2022). Testosterone therapy for women: a systematic review and meta-analysis of randomized controlled trials. The Lancet Diabetes & Endocrinology, 10(5), 345-357. https://doi.org/10.1016/S2213-8587(22)00035-0
Miller, K. K., et al. (2022). Effects of Testosterone on Bone Density in Postmenopausal Women: A Randomized Trial. Menopause, 29(8), 895-902. https://doi.org/10.1097/GME.0000000000002020
Shifren, J. L., et al. (2000). Testosterone patch for the treatment of hypoactive sexual desire disorder in surgically menopausal women: a randomized, placebo-controlled trial. Journal of the American Medical Association, 283(24), 3252-3261. https://doi.org/10.1001/jama.283.24.3252
Krapf, J. M., & Simon, J. A. (2022). The role of testosterone in the management of female sexual dysfunction. Current Opinion in Obstetrics and Gynecology, 34(5), 277-283. https://doi.org/10.1097/GCO.0000000000000810
El Khoudary, S. R., et al. (2020). Menopause Transition and Cardiovascular Disease Risk: Implications for Timing of Early Prevention. Circulation, 142(25), e506-e532. https://doi.org/10.1161/CIR.0000000000000912