Testosterone therapy
In men with low testosterone, trials found small gains in libido and erectile function, about 1.6 kg more fat-free mass and 1.6 kg less fat. Pooled trials found heart attack and stroke rates matched placebo, but arrhythmias rose about 50%. Erythrocytosis rose about eightfold, and fractures were more frequent.
- Status
- Prescription drug in the US, FDA-approved for testosterone replacement in men with hypogonadism. A Schedule III controlled substance. No testosterone product is FDA-approved for women in the US.
- Also called
- TRT, testosterone replacement therapy, testosterone cypionate, testosterone enanthate, testosterone gel, AndroGel, testosterone undecanoate, test cyp, test e
- Taken for
- low testosterone, libido, erectile function, muscle gain, strength, fat loss, bone density, energy, mood, aging, women's libido
Strong several reviews agree · Moderate one review or consistent trials · Limited one or a few small studies · Untested no study in people, listed with what it rests on
Shown to help5
- StrongShown to add about 1.6 kg of fat-free mass and cut about 1.6 kg of body fat in middle-aged and older men, with no change in weight.
- StrongShown to raise satisfying sexual events, desire, arousal and orgasm, and lower sexual distress, in postmenopausal women. Long-term data are limited.
- ModerateShown to raise sexual desire, erectile function and satisfaction slightly in men with low testosterone, with effects small by usual standards.
- ModerateShown to raise spine bone density about 3.7% in middle-aged and older men, with no change at the hip. Density is not fracture.
- LimitedOne small 1996 trial at high doses found more muscle size and strength in young men with normal testosterone, most with training.
Reported risks7
- ModerateShown to stop sperm production in 65% of healthy men at contraceptive doses. Sperm recovered in 90% within 12 months and all within 24 months of stopping.Very common
- ModerateShown to raise clinical fractures, 3.5% against 2.5% on placebo, in men with low testosterone. Major osteoporotic, spine and hip fractures did not differ.Common
- StrongShown to raise heart rhythm problems about 53% over placebo in men aged 40 and older. One large trial found more atrial fibrillation.How often is not known
- ModerateShown to raise the risk of a high red cell count about eightfold in men with low testosterone, based on few events.How often is not known
- ModerateShown to raise acne, hair growth and weight in women. Oral testosterone raised LDL cholesterol, while other routes did not change lipids.How often is not known
- LimitedOne trial found more acute kidney injury and blood clots in the lungs on testosterone in men at high heart risk. Event counts were not given.How often is not known
- LimitedLinked to more kidney injury, implant infection, revision surgery and fracture after knee replacement in people using testosterone.How often is not known
What people take it for, and what was found
Shown to help5
Sexual function in men with low testosterone
Shown to raise sexual desire, erectile function and satisfaction slightly in men with low testosterone, with effects small by usual standards.
The numbers and sources
- Effect
- Compared with placebo, testosterone raised sexual desire by an SMD of 0.17 (95% CI 0.01 to 0.34, 1,383 men), erectile function by 0.16 (95% CI 0.06 to 0.27, 1,344 men) and sexual satisfaction by 0.16 (95% CI 0.01 to 0.31, 676 men) [1].
- Population
- Adult men with morning testosterone of 300 ng/dL or less and at least one symptom, in 4 trials (1,779 men) lasting at least 12 weeks [1].
- Sources
- [1]
- Caveats
- Effect sizes under 0.2 are small by conventional thresholds. Four trials, all judged at low risk of bias.
Fat-free mass and body fat in middle-aged and older men
Shown to add about 1.6 kg of fat-free mass and cut about 1.6 kg of body fat in middle-aged and older men, with no change in weight.
The numbers and sources
- Effect
- Testosterone raised fat-free mass by 1.6 kg (95% CI 0.6 to 2.6), a 2.7% rise over baseline, and cut total body fat by 1.6 kg (95% CI 0.6 to 2.5), a 6.2% drop. Body weight did not change [2]. A 2026 systematic review of 8 double-blind placebo-controlled trials in men with obesity and type 2 diabetes or metabolic syndrome found the most consistent effect was more lean mass and less fat mass [3].
- Population
- 1,083 men in 29 RCTs, weighted mean age 64.5, mean baseline testosterone 10.9 nmol/L [2]; men with functional secondary hypogonadism, obesity and type 2 diabetes or metabolic syndrome in 8 RCTs [3].
- Sources
- [2], [3]
- Caveats
- The meta-analysis is from 2005, and dose and preparation explained some of the heterogeneity between trials [2]. The 2026 review was not pooled and rated certainty for lean and fat mass as low [3]. Fat-free mass counts water and organs as well as muscle.
Bone density in men
Shown to raise spine bone density about 3.7% in middle-aged and older men, with no change at the hip. Density is not fracture.
The numbers and sources
- Effect
- Lumbar spine bone mineral density rose 3.7% (95% CI 1.0 to 6.4) over placebo. Femoral neck density did not differ. Bone resorption markers fell by an SMD of -0.6 (95% CI -1.0 to -0.2) [2].
- Population
- Middle-aged and older men, 29 RCTs [2].
- Sources
- [2]
- Caveats
- Density is not fracture. The one large trial that counted fractures found more of them on testosterone (see Risks) [4].
Muscle size and strength at high doses in young men
One small 1996 trial at high doses found more muscle size and strength in young men with normal testosterone, most with training.
The numbers and sources
- Effect
- Over 10 weeks without exercise, men on testosterone gained more triceps area (424 vs -81 mm²), quadriceps area (607 vs -131 mm²), bench press (9 vs -1 kg) and squat (16 vs 3 kg) than men on placebo. With training, the testosterone group gained 6.1 kg of fat-free mass, 22 kg on bench press and 38 kg on squat, more than either non-exercise group. Mood and behavior did not change in any group [5].
- Population
- 43 healthy men with normal testosterone, in 4 groups, for 10 weeks [5].
- Sources
- [5]
- Caveats
- One small trial from 1996 at a dose the authors describe as supraphysiologic. It does not address men with low testosterone or use over years.
Sexual function in postmenopausal women
Shown to raise satisfying sexual events, desire, arousal and orgasm, and lower sexual distress, in postmenopausal women. Long-term data are limited.
The numbers and sources
- Effect
- Compared with placebo or a comparator, testosterone raised satisfying sexual event frequency by a mean of 0.85 (95% CI 0.52 to 1.18), desire by an SMD of 0.36 (95% CI 0.22 to 0.50), arousal by 0.28 (95% CI 0.21 to 0.35) and orgasm by 0.25 (95% CI 0.18 to 0.32), and lowered sexual distress by an SMD of -0.27 (95% CI -0.36 to -0.17) [6]. A 2026 systematic review reported improved desire with transdermal testosterone in postmenopausal trials, including one of more than 800 women. In two premenopausal trials of 31 to 261 women, libido, satisfying sexual events and satisfaction improved [7].
- Population
- 36 blinded RCTs with 8,480 participants, at least 12 weeks long, analyzed in postmenopausal women [6]; 33 studies, including 7 RCTs in postmenopausal and 2 in premenopausal women [7].
- Sources
- [6], [7]
- Caveats
- No effects were found on body composition, musculoskeletal measures or cognition, but few women contributed data to those outcomes [6]. The 2026 review was not pooled, and androgen levels and long-term safety were inconsistently reported [7]. Long-term data are limited.
Mixed results1
Muscle strength in middle-aged and older men
Limited evidence: strength gains in middle-aged and older men were small and varied widely across trials.
The numbers and sources
Doses studied
TRAVERSE used a daily 1.62% transdermal testosterone gel, with the dose adjusted to keep testosterone between 350 and 750 ng/dL [8]. The 1996 trial in young men used 600 mg of testosterone enanthate by injection weekly for 10 weeks [5]. The 2022 pooled analysis included any formulation, dose or route given for at least 3 months [9].
Risks
Reported risks7
Lower sperm production and fertility
Shown to stop sperm production in 65% of healthy men at contraceptive doses. Sperm recovered in 90% within 12 months and all within 24 months of stopping.
The numbers and sources
- How common
- Very common: more than 1 in 10 people.
- Effect
- In 271 healthy fertile men given 200 mg testosterone enanthate weekly, 65% had no sperm in three consecutive samples by 6 months, after a mean of 120 days. After injections stopped, the median time to a sperm concentration of at least 20 million per mL was 3.7 months [19]. Across 30 studies of 1,549 men on testosterone alone or with a progestogen, the probability of sperm recovering to 20 million per mL was 67% within 6 months, 90% within 12 months, 96% within 16 months and 100% within 24 months of stopping. Recovery was slower after longer treatment and longer-acting testosterone preparations [20].
- Population
- Healthy men aged 18 to 51 with normal testosterone, studied as male contraception [19][20].
- Sources
- [19], [20]
- Caveats
- These are contraception studies in men with normal testosterone, at doses chosen to stop sperm production. They do not report rates for men treated for low testosterone. The pooled analysis includes regimens that added a progestogen [20].
Fractures
Shown to raise clinical fractures, 3.5% against 2.5% on placebo, in men with low testosterone. Major osteoporotic, spine and hip fractures did not differ.
The numbers and sources
- How common
- Common: between 1 in 100 and 1 in 10 people.
- Effect
- After a median of 3.19 years, a clinical fracture occurred in 91 men (3.50%) on testosterone and 64 (2.46%) on placebo (HR 1.43, 95% CI 1.04 to 1.97). Fracture incidence also appeared higher on testosterone for every other fracture end point [4]. A meta-analysis of 2 RCTs found more clinical fractures on testosterone (RR 1.55, 95% CI 1.21 to 1.97), with no difference in major osteoporotic fractures (RR 0.62, 95% CI 0.12 to 3.35), vertebral fractures (RR 0.87, 95% CI 0.29 to 2.58) or hip fractures (RR 1.02, 95% CI 0.33 to 3.09) [13].
- Population
- 5,204 men aged 45 to 80 with low testosterone in the TRAVERSE fracture subtrial [4]; 2,711 hypogonadal men in 2 RCTs [13].
- Sources
- [4], [13]
- Caveats
- The meta-analysis pooled only 2 trials, and the added fractures were mainly non-major ones [13]. The TRAVERSE subtrial was not designed around men with osteoporosis.
Cardiac arrhythmias
Shown to raise heart rhythm problems about 53% over placebo in men aged 40 and older. One large trial found more atrial fibrillation.
The numbers and sources
- How common
- How often is not known: the sources give no rate.
- Effect
- Pooled RCTs with at least 12 months of follow-up found more cardiac arrhythmias on testosterone than placebo (RR 1.53, 95% CI 1.20 to 1.97) [10]. A second meta-analysis found an arrhythmia signal among nonfatal cardiovascular events (OR 1.58, 95% CI 1.21 to 2.05) [12]. TRAVERSE reported a higher incidence of atrial fibrillation on testosterone [8].
- Population
- 9,280 men aged 40 and older in 23 RCTs [10]; 6,598 participants in the arrhythmia analysis of a 31-trial review [12]; 5,246 men aged 45 to 80 at high cardiovascular risk [8].
- Sources
- [10], [12], [8]
- Caveats
- The reviews share trials. The second review's authors call the clinical significance of the signal uncertain, and the same review found lower total cholesterol, LDL and triglycerides on testosterone [12].
Acute kidney injury and pulmonary embolism
One trial found more acute kidney injury and blood clots in the lungs on testosterone in men at high heart risk. Event counts were not given.
The numbers and sources
- How common
- How often is not known: the sources give no rate.
- Effect
- TRAVERSE reported a higher incidence of acute kidney injury and pulmonary embolism in the testosterone group than the placebo group [8].
- Population
- 5,246 men aged 45 to 80 at high cardiovascular risk [8].
- Sources
- [8]
- Caveats
- One trial. The abstract reports these as observed differences without event counts.
- Why limited
- This rests on one trial, of 5,246 people. Strength counts independent studies that agree, so one trial is limited at any size.
Erythrocytosis
Shown to raise the risk of a high red cell count about eightfold in men with low testosterone, based on few events.
The numbers and sources
- How common
- How often is not known: the sources give no rate.
- Effect
- Testosterone raised the risk of erythrocytosis (high red cell count) by a relative risk of 8.14 (95% CI 1.87 to 35.40) compared with placebo [1].
- Population
- 1,579 men with low testosterone in placebo-controlled trials of at least 12 weeks [1].
- Sources
- [1]
- Caveats
- The wide interval reflects few events. Lower urinary tract symptoms did not differ from placebo [1].
Complications after knee replacement
Linked to more kidney injury, implant infection, revision surgery and fracture after knee replacement in people using testosterone.
The numbers and sources
- How common
- How often is not known: the sources give no rate.
- Effect
- In people having a total knee replacement, testosterone use was linked to more acute kidney injury within 3 months (OR 1.3, 95% CI 1.1 to 1.6), joint infection around the implant (OR 1.8, 95% CI 1.3 to 2.7), revision surgery (OR 1.3, 95% CI 1.2 to 1.5) and fracture around the implant (OR 2.0, 95% CI 1.1 to 3.7). Pulmonary embolism (OR 1.2, 95% CI 0.9 to 1.6) and deep vein thrombosis (OR 1.1, 95% CI 0.8 to 1.4) did not differ [18].
- Population
- 4 retrospective matched cohort studies [18].
- Sources
- [18]
- Caveats
- Observational studies only. They show association, not cause [18].
Acne, hair growth and weight gain in women
Shown to raise acne, hair growth and weight in women. Oral testosterone raised LDL cholesterol, while other routes did not change lipids.
The numbers and sources
- How common
- How often is not known: the sources give no rate.
- Effect
- Women on testosterone were more likely to report acne and hair growth, and gained weight overall. Oral testosterone raised LDL cholesterol and lowered total cholesterol, HDL and triglycerides; non-oral routes did not change lipids. No serious adverse events were recorded [6].
- Population
- 36 RCTs, 8,480 participants [6].
- Sources
- [6]
- Caveats
- Trials lasted from 12 weeks, and long-term safety in women was not established [6].
Checked, no increase found3
Heart attack, stroke and cardiovascular death
Heart attack, stroke and cardiovascular death were about as common as on placebo in men with low testosterone, including men at high heart risk.
The numbers and sources
- How common
- Common: between 1 in 100 and 1 in 10 people.
- Effect
- In TRAVERSE, a major cardiac event occurred in 182 men (7.0%) on testosterone and 190 (7.3%) on placebo (HR 0.96, 95% CI 0.78 to 1.17), which met the trial's noninferiority margin [8]. In a pooled analysis of 35 trials, cardiovascular events occurred in 7.5% on testosterone and 7.2% on placebo (OR 1.07, 95% CI 0.81 to 1.42). Deaths were 0.4% versus 0.8% (OR 0.46, 95% CI 0.17 to 1.24) [9]. Across RCTs with at least 12 months of follow-up, all-cause mortality (RR 0.85, 95% CI 0.60 to 1.19), cardiovascular mortality (RR 0.85, 95% CI 0.65 to 1.12), stroke (RR 1.00, 95% CI 0.67 to 1.50) and myocardial infarction (RR 0.94, 95% CI 0.69 to 1.28) did not differ from placebo [10]. A meta-analysis of 41 RCTs found no rise in major cardiac events (OR 0.83, 95% CI 0.52 to 1.32) [11].
- Population
- 5,246 men aged 45 to 80 with low testosterone and existing or high risk of cardiovascular disease, mean follow-up 33 months [8]; 5,601 men, mean age 65, with individual data from 3,431 men followed for a mean of 9.5 months [9]; 9,280 men aged 40 and older, mean age 64.6, in 23 RCTs [10]; 11,161 men in 41 RCTs [11].
- Sources
- [8], [9], [10], [11]
- Caveats
- Mean treatment in TRAVERSE was 21.7 months, and the trial was funded by AbbVie and others [8]. The pooled analysis authors note a lack of long-term data [9]. Comorbidities contributed to heterogeneity in the 41-trial analysis (I² 53.2%) [11].
Prostate cancer
Prostate cancer was about as common as on placebo in short to mid-term trials of men. After prostate cancer treatment, recurrence was low in observational data.
The numbers and sources
- How common
- How often is not known: the sources give no rate.
- Effect
- In a meta-analysis of 41 RCTs, testosterone did not raise prostate cancer events (OR 0.88, 95% CI 0.52 to 1.51) or clinically significant prostate cancer (OR 1.13, 95% CI 0.39 to 3.26) [11]. In men treated with testosterone after prostatectomy for prostate cancer, the pooled biochemical recurrence rate was 3.5% (95% CI 1.5 to 8.5) [14]. Across observational studies, recurrence ranged from 0% to 7% after prostatectomy and 0% to 6% after radiotherapy, and progression on active surveillance did not differ from untreated men [15]. Among 295 treated men on active surveillance, no prostate cancer deaths or metastases were reported [16].
- Population
- 11,161 men in 41 RCTs [11]; 398 men in 7 retrospective studies, mean follow-up 29.6 months [14]; 19 observational studies [15]; 295 treated men and 6,826 untreated comparators on active surveillance in 7 observational studies, followed 2.3 to 6.1 years [16].
- Sources
- [11], [14], [15], [16]
- Caveats
- The RCT data are short to mid term [11]. Data in men with prostate cancer are retrospective, mostly in low-risk disease, with no randomized trials [14][15][16].
Cardiovascular deaths in women
No cardiovascular deaths occurred in 13 trials of testosterone in women lasting up to a year, too short to show long-term effects.
The numbers and sources
- How common
- How often is not known: the sources give no rate.
- Effect
- Thirteen RCTs of transdermal testosterone in women, lasting 8 to 52 weeks, reported no cardiovascular deaths [17].
- Population
- 2,628 women in 13 RCTs [17].
- Sources
- [17]
- Caveats
- Trials this short cannot show long-term cardiovascular safety, and the review did not pool data [17].
Claims tested and not found
- That testosterone raises energy or mood in men with low testosterone. Pooled placebo-controlled trials found no effect on energy or mood [1]. In young men on a high dose, mood did not change [5]. A 2026 systematic review of 11 small RCTs reported fewer depressive symptoms in men with treatment-resistant depression, with inconsistent results for anxiety [21].
- That testosterone lowers fracture risk. In 5,204 men, fractures were more frequent on testosterone than placebo [4]. A meta-analysis of 2 RCTs found more clinical fractures and no difference in hip or vertebral fractures [13].
- That testosterone changes body composition, muscle or physical function in women. No effects were found on body composition or musculoskeletal measures, in a small number of women with data [6]. In 129 women aged 65 and older after hip fracture, adding testosterone gel to 24 weeks of supervised exercise did not change 6-minute walk distance against placebo gel (42.7 vs 40.5 m) [22].
- That testosterone improves thinking and memory after menopause. A meta-analysis of 3 studies in 244 postmenopausal women found no significant effect on executive function, verbal memory or visuospatial memory. The authors judge the data too few to establish an effect either way [23].
Sources
- Ponce OJ, Spencer-Bonilla G, Alvarez-Villalobos N, et al. The Efficacy and Adverse Events of Testosterone Replacement Therapy in Hypogonadal Men: A Systematic Review and Meta-Analysis of Randomized, Placebo-Controlled Trials. The Journal of Clinical Endocrinology & Metabolism. 2018. https://doi.org/10.1210/jc.2018-00404
- Isidori AM, Giannetta E, Greco EA, et al. Effects of testosterone on body composition, bone metabolism and serum lipid profile in middle-aged men: a meta-analysis. Clinical Endocrinology. 2005. https://doi.org/10.1111/j.1365-2265.2005.02339.x
- Ntais C, Vantarakis A, Chatziprodromidou IP. Metabolic Effects of Testosterone Replacement Therapy in Men with Functional Secondary Hypogonadism, Obesity and Type 2 Diabetes or Metabolic Syndrome: A Systematic Review. Medical Sciences. 2026. https://doi.org/10.3390/medsci14030418
- Snyder PJ, Bauer DC, Ellenberg SS, et al. Testosterone Treatment and Fractures in Men with Hypogonadism. New England Journal of Medicine. 2024. https://doi.org/10.1056/NEJMoa2308836
- Bhasin S, Storer TW, Berman N, et al. The Effects of Supraphysiologic Doses of Testosterone on Muscle Size and Strength in Normal Men. New England Journal of Medicine. 1996. https://doi.org/10.1056/NEJM199607043350101
- Islam RM, Bell RJ, Green S, et al. Safety and efficacy of testosterone for women: a systematic review and meta-analysis of randomised controlled trial data. The Lancet Diabetes & Endocrinology. 2019. https://doi.org/10.1016/S2213-8587(19)30189-5
- Furlan VA, Hammad MAM, Quesada S, et al. Testosterone therapy for female sexual dysfunction: a systematic review of the literature demonstrating outcomes in premenopausal and postmenopausal women. The Journal of Sexual Medicine. 2026. https://doi.org/10.1093/jsxmed/qdag206
- Lincoff AM, Bhasin S, Flevaris P, et al. Cardiovascular Safety of Testosterone-Replacement Therapy. New England Journal of Medicine. 2023. https://doi.org/10.1056/NEJMoa2215025
- Hudson J, Cruickshank M, Quinton R, et al. Adverse cardiovascular events and mortality in men during testosterone treatment: an individual patient and aggregate data meta-analysis. The Lancet Healthy Longevity. 2022. https://doi.org/10.1016/S2666-7568(22)00096-4
- Braga MAP, Rivera A, Marinheiro G, et al. Long-Term Cardiovascular Safety of Testosterone-Replacement Therapy in Middle-Aged and Older Men: A Meta-analysis of Randomized Controlled Trials. American Journal of Cardiovascular Drugs. 2025. https://doi.org/10.1007/s40256-025-00737-w
- García-Becerra CA, Arias-Gallardo MI, Juárez-García JE, et al. Cardiovascular and prostate cancer risk associated to testosterone replacement therapy - a systematic review and meta-analysis of 41 randomized controlled trials. International Journal of Impotence Research. 2026. https://doi.org/10.1038/s41443-026-01237-4
- Qin H, Zuo D, Wang Z, et al. Cardiovascular safety in middle-aged and older men under testosterone replacement therapy: a systematic review and meta-analysis. Endocrine. 2026. https://doi.org/10.1007/s12020-026-04773-7
- Anagnostis P, Divaris E, Zidrou M, et al. Effect of testosterone replacement therapy on fracture risk in hypogonadal men: A systematic review and meta-analysis of randomized controlled trials. Maturitas. 2026. https://doi.org/10.1016/j.maturitas.2026.108961
- Corona G, Morgado LA, Capogrosso P, et al. Testosterone Therapy After Radical Prostatectomy: Insights From a Systematic Review and Meta-Analysis. Andrology. 2026. https://doi.org/10.1111/andr.70285
- Santucci J, Stapleton P, Perera M, et al. Oncological safety of testosterone replacement therapy in men with localised prostate cancer: a systematic review of observational studies. BJU International. 2025. https://doi.org/10.1111/bju.16870
- Aly M, Alshunaigat N, Habana Y, et al. Testosterone Replacement Therapy in Men With Prostate Cancer on Active Surveillance: A Systematic Review of Oncological Safety. Andrology. 2026. https://doi.org/10.1111/andr.70313
- Viana DPDC, Câmara LC, Alto LSM. Cardiovascular mortality associated with testosterone therapy in cisgender women and transgender men: a systematic review. Frontiers in Endocrinology. 2026. https://doi.org/10.3389/fendo.2026.1789504
- Regmi A, Sami A, Baral S, et al. Association of testosterone replacement therapy on medical and implant-related complications after total knee arthroplasty: a systematic review and meta-analysis. The Knee. 2026. https://doi.org/10.1016/j.knee.2026.104637
- World Health Organization Task Force on methods for the regulation of male fertility. Contraceptive efficacy of testosterone-induced azoospermia in normal men. Lancet. 1990. https://pubmed.ncbi.nlm.nih.gov/1977002/
- Liu PY, Swerdloff RS, Christenson PD, et al. Rate, extent, and modifiers of spermatogenic recovery after hormonal male contraception: an integrated analysis. The Lancet. 2006. https://doi.org/10.1016/s0140-6736(06)68614-5
- Canal de Velasco LM, González Flores JE, Vargas L, et al. Psychiatric and Cognitive Effects of Testosterone Therapy in Adult Men: A Systematic Review of Clinical Evidence and Mechanistic Insights. Cureus. 2026. https://doi.org/10.7759/cureus.102894
- Binder EF, Bartley JM, Berry SD, et al. Combining Exercise Training and Testosterone Therapy in Older Women After Hip Fracture: The STEP-HI Randomized Clinical Trial. JAMA Network Open. 2025. https://doi.org/10.1001/jamanetworkopen.2025.10512
- Faulkner A, Desai R, Keay N, et al. Testosterone therapy for cognition in menopause: A systematic review and meta-analysis. Reproduction and Fertility. 2026. https://doi.org/10.1530/raf-26-0080