Testosterone Therapy in Women

Decades of use without established indications

The 2019 Global Consensus Position Statement on the Use of Testosterone Therapy for Women states that there are no clearly established indications for testosterone therapy for women, and that clinicians have nonetheless treated women with testosterone for decades with the intention of alleviating a variety of symptoms, with uncertain benefits and risks. It adds that in most countries the therapy is prescribed off-label, using either formulations approved for men with modified dosing or compounded preparations.

Attempts to obtain approved female products

A 2021 clinical practice guideline from the International Society for the Study of Women's Sexual Health (ISSWSH) summarizes the regulatory history as its authors describe it. Two transdermal products were evaluated by the US Food and Drug Administration more than a decade earlier: a gel that failed to show efficacy greater than placebo, and a patch that did show efficacy over placebo but was not approved after the agency's advisory committee raised safety concerns. The guideline reports that the European Medicines Agency approved the patch only for women with surgically induced menopause who were also taking estrogen, and that the manufacturer later withdrew it because of poor sales.

The same guideline states that a testosterone cream for postmenopausal women with hypoactive sexual desire disorder was approved in Australia in 2020, that a testosterone implant once approved in Australia is no longer available, and that no government-approved testosterone product for this use was available in the United States. It describes clinicians as having resorted to male-approved and compounded products without a clear standard of care.

Reviews, guidelines and consensus statements

A Cochrane systematic review of testosterone added to hormone therapy in peri- and postmenopausal women appeared in 2005. An Endocrine Society clinical practice guideline on androgen therapy in women followed in 2014, produced by a task force appointed by the Endocrine Society together with the American Congress of Obstetricians and Gynecologists, the American Society for Reproductive Medicine, the European Society of Endocrinology and the International Menopause Society.

The Global Consensus Position Statement was drafted by a task force that met in Berlin on 17 May 2019, after a systematic review and meta-analysis was commissioned. It was published simultaneously in four journals and endorsed by eleven organizations, including the International Menopause Society, the Endocrine Society, the North American Menopause Society, the Royal College of Obstetricians and Gynaecologists and the Royal Australian and New Zealand College of Obstetricians and Gynaecologists. The ISSWSH guideline of 2021 builds on it.

Names and scope

Sources use the phrases testosterone therapy for women, androgen therapy in women and testosterone supplementation. This page uses Testosterone Therapy in Women for testosterone prescribed to women as a medical treatment. On Machipedia it belongs to the family page Hormone Replacement Therapy, which is not repeated here, and it sits alongside Testosterone Replacement Therapy (TRT), Menopausal Estrogen-Progestogen Therapy, Hormone Pellet Therapy and Bioidentical Hormone Replacement, each covered on its own page.

Hypoactive sexual desire disorder

The Global Consensus Position Statement treats hypoactive sexual desire disorder (HSDD) and female sexual arousal disorder as distinct conditions with different causes and responses to treatment. It advises that HSDD be diagnosed through thorough clinical assessment guided by criteria such as those of the ISSWSH or the eleventh edition of the International Classification of Diseases, and that no blood level of any circulating androgen can separate women with sexual dysfunction from those without it.

Androgen deficiency and bioidentical wording

The Endocrine Society guideline continues to recommend against diagnosing an androgen deficiency syndrome in healthy women, citing the lack of a well-defined syndrome and the absence of data linking androgen levels to specific signs or symptoms. The Menopause Society's 2022 hormone therapy position statement distinguishes government-approved bioidentical hormone therapy from compounded bioidentical hormone therapy, which a compounding pharmacist prepares from a prescriber's order and which may combine several hormones, including testosterone, in untested combinations or nonstandard routes such as implants, pellets or troches.

Assessment before any prescribing

The consensus statement says that low sexual desire has several contributing causes, including physical illness, interpersonal difficulties, psychological distress and cultural values, and that treatment should follow a biopsychosocial model that can include medication, psychotherapy or both. It states that other contributing factors must be identified and addressed before testosterone is started, and that a total testosterone level should be used as a baseline for monitoring, not to diagnose HSDD.

The ISSWSH guideline adds that clinicians should obtain informed consent and use shared decision-making that includes a discussion of off-label use, benefits and risks. It describes candidates as postmenopausal women with a decline in sexual interest that causes distress, and notes that limited data also support use in women in late reproductive age.

Formulations described in general terms

Where no approved female preparation exists, the consensus statement calls off-label prescribing of an approved male formulation reasonable, provided blood concentrations stay within the physiologic range for women. The ISSWSH guideline describes transdermal forms such as patches, gels, creams and sprays as the most physiologic, and does not recommend injections, oral products, implants or compounded products. Specific products and amounts are outside the scope of this page.

Monitoring and stopping

The consensus statement recommends a baseline total testosterone measurement, a repeat measurement a few weeks after starting, and checks for signs of androgen excess with blood testing roughly every six months to screen for overuse. It also states that treatment should stop if no benefit is experienced by six months. These are expert-opinion and low-grade recommendations as the statement labels them.

Who prescribes and professional oversight

The sources reviewed are written for physicians and other prescribers by professional societies in endocrinology, menopause medicine, sexual medicine and gynecology. The ISSWSH guideline notes that, outside Australia, prescriptions are usually off-label and often paid for out of pocket. The Menopause Society statement advises that prescribers of compounded bioidentical hormone therapy document the medical indication for choosing it over government-approved options. The sources reviewed describe no registration scheme specific to this therapy.

Low sexual desire after menopause

The Global Consensus Position Statement concludes that the only evidence-based indication for testosterone in women is HSDD in postmenopausal women diagnosed after formal biopsychosocial assessment. The Endocrine Society guideline likewise describes short-term efficacy and safety of testosterone at high physiological levels in postmenopausal women with sexual dysfunction due to HSDD.

NICE guideline NG23 on menopause advises clinicians to consider testosterone supplementation for people with low sexual desire associated with menopause if hormone replacement therapy alone is not effective, and records that in November 2015 this was an off-label use of testosterone.

Broader uses and what the sources say about them

The Endocrine Society guideline recommends against the general use of testosterone for infertility, sexual dysfunction other than HSDD, cognitive, cardiovascular, metabolic or bone health, or general well-being. The consensus statement finds insufficient data to support testosterone for any other symptom or condition or for disease prevention. The sources reviewed do not evaluate specific clinic claims about energy, mood, memory or anti-ageing, and nothing in them supports carrying the HSDD finding over to those claims.

The consensus statement does not recommend any testosterone preparation that produces supraphysiologic concentrations, naming pellets and injections, and recommends against compounded testosterone for HSDD. Pellet-based and compounded approaches are covered on the Hormone Pellet Therapy and Bioidentical Hormone Replacement pages.

Systematic reviews of randomized trials

A 2019 systematic review and meta-analysis in The Lancet Diabetes & Endocrinology included 36 randomized, blinded trials of at least 12 weeks with 8,480 participants. Compared with placebo or a comparator, testosterone increased sexual function outcomes in postmenopausal women, including sexual desire (standardized mean difference 0.36) and reduced sexual distress. The authors report no effects on body composition, musculoskeletal variables or cognitive measures, though few women contributed data for those outcomes.

An earlier Cochrane review of 23 trials with 1,957 participants compared testosterone plus hormone therapy with hormone therapy alone. It found improved sexual function scores in postmenopausal women, insufficient evidence for perimenopausal women or other outcomes, and limited power because only some studies could be pooled. The median trial lasted six months.

How guidelines read the trials

The consensus statement and the ISSWSH guideline both describe a moderate therapeutic effect on HSDD. The ISSWSH guideline notes that the gel evaluated by regulators did not beat placebo, which its authors attribute to a high placebo response. The Endocrine Society guideline reports that a woman's own testosterone level did not predict response to treatment.

Gaps the sources identify

The consensus statement says the evidence base excluded women at high cardiometabolic risk and calls for larger, adequately powered trials, standardized outcomes, and studies of bone, muscle and cognition. It no longer accepts satisfying sexual events as a primary trial measure. The ISSWSH guideline states that physiologic-dose trial safety data are not available beyond 24 months, and that results of one large cardiovascular and breast safety trial were issued in press releases, not in a peer-reviewed publication.

Adverse effects reported in trials

The 2019 meta-analysis found that testosterone was associated with a greater likelihood of acne and hair growth, with no serious adverse events recorded. An overall weight increase was reported. Oral testosterone raised LDL cholesterol and lowered total cholesterol, HDL cholesterol and triglycerides, while non-oral routes did not change lipids. The Cochrane review also reported a decrease in HDL cholesterol when testosterone was added to hormone therapy.

The ISSWSH guideline cites relative risks of 1.46 for acne and 1.69 for hair growth, and states that supraphysiologic testosterone levels can cause acne, excess facial hair, voice deepening and scalp hair thinning, while androgenic effects are rare when levels stay in the premenopausal range. It also warns that topical products can transfer to other people and pets in close contact.

Long-term uncertainty

Both the consensus statement and the ISSWSH guideline state that long-term safety has not been established. The guideline reports that long-term data on breast cancer and cardiovascular events beyond about two years are limited and inconclusive, and that mammographic breast density did not change in several small trials that were insufficient to assess breast cancer risk.

Contraindications and cautions

The ISSWSH guideline states that women should not receive testosterone if they show signs of clinical androgen excess or take antiandrogen medication, and that liver disease and high blood lipids are contraindications. Use in women with hormone-dependent cancers should be considered only with the specialists providing cancer care. It recommends liver function and lipid testing before starting and notes that women with low sex hormone-binding globulin may have androgenic effects at normal blood levels.

Compounded products, pellets and injections

The consensus statement cannot recommend compounded bioidentical testosterone because of the lack of efficacy and safety evidence. The Menopause Society statement describes safety concerns with compounded hormone therapy, including minimal government monitoring, overdosing and underdosing, impurities, lack of sterility and no label outlining risks. The ISSWSH guideline says implants may produce supraphysiologic levels and cannot be adjusted once placed.

This page is information only. The sources do not support delaying or replacing medical evaluation of low sexual desire, which they describe as having many possible causes that a clinician assesses.