Effect of Testosterone Supplementation With and Without a Dual 5α-Reductase Inhibitor on Fat-Free Mass in Men With Suppressed Testosterone Production: A Randomized Controlled Trial
Open accessAbstract
CONTEXT: Steroid 5α-reductase inhibitors are used to treat benign prostatic hyperplasia and androgenic alopecia, but the role of 5α-dihydrotestosterone (DHT) in mediating testosterone's effects on muscle, sexual function, erythropoiesis, and other androgen-dependent processes remains poorly understood. OBJECTIVE: To determine whether testosterone's effects on muscle mass, strength, sexual function, hematocrit level, prostate volume, sebum production, and lipid levels are attenuated when its conversion to DHT is blocked by dutasteride (an inhibitor of 5α-reductase type 1 and 2). DESIGN, SETTING, AND PATIENTS: The 5α-Reductase Trial was a randomized controlled trial of healthy men aged 18 to 50 years comparing placebo plus testosterone enthanate with dutasteride plus testosterone enanthate from May 2005 through June 2010. INTERVENTIONS: Eight treatment groups received 50, 125, 300, or 600 mg/wk of testosterone enanthate for 20 weeks plus placebo (4 groups) or 2.5 mg/d of dutasteride (4 groups). MAIN OUTCOME MEASURES: The primary outcome was change in fat-free mass; secondary outcomes: changes in fat mass, muscle strength, sexual function, prostate volume, sebum production, and hematocrit and lipid levels. RESULTS: A total of 139 men were randomized; 102 completed the 20-week intervention. Men assigned to dutasteride were similar at baseline to those assigned to placebo. The mean fat-free mass gained by the dutasteride groups was 0.6 kg (95% CI, -0.1 to 1.2 kg) when receiving 50 mg/wk of testosterone enanthate, 2.6 kg (95% CI, 0.9 to 4.3 kg) for 125 mg/wk, 5.8 kg (95% CI, 4.8 to 6.9 kg) for 300 mg/wk, and 7.1 kg (95% CI, 6.0 to 8.2 kg) for 600 mg/wk. The mean fat-free mass gained by the placebo groups was 0.8 kg (95% CI, -0.1 to 1.7 kg) when receiving 50 mg/wk of testosterone enanthate, 3.5 kg (95% CI, 2.1 to 4.8 kg) for 125 mg/wk, 5.7 kg (95% CI, 4.8 to 6.5 kg) for 300 mg/wk, and 8.1 kg (95% CI, 6.7 to 9.5 kg) for 600 mg/wk. The dose-adjusted differences between the dutasteride and placebo groups for fat-free mass were not significant (P = .18). Changes in fat mass, muscle strength, sexual function, prostate volume, sebum production, and hematocrit and lipid levels did not differ between groups. CONCLUSION: Changes in fat-free mass in response to graded testosterone doses did not differ in men in whom DHT was suppressed by dutasteride from those treated with placebo, indicating that conversion of testosterone to DHT is not essential for mediating its anabolic effects on muscle. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00493987.
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Inhibition of aromatase abrogated the fat-reducing effects of testosterone, but 5αR inhibition did not alter the effects of testosterone.
“Inhibition of aromatase abrogated these effects but consistent with the previous findings of Bhasin et al., 170 5αR inhibition did not alter the effects of testosterone.”
From The role of the androgen receptor in the pathogenesis of obesity and its utility as a target for obesity treatments (2022) · cites this paper as [170]
In a mechanistic RCT in healthy men, the fat-reducing effects of testosterone treatment were not altered by co-administration of the 5αR inhibitor dutasteride.
“in a mechanistic RCT in healthy men, the fat‐reducing effects of testosterone treatment were not altered by co‐administration of the 5αR inhibitor dutasteride”
From The role of the androgen receptor in the pathogenesis of obesity and its utility as a target for obesity treatments (2022) · cites this paper as [170]
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- Authors
- Bhasin, S., Travison, T. G., Storer, T. W., Lakshman, K., Kaushik, M., Mazer, N. A., Ngyuen, A.-H., Davda, M. N., Jara, H., Aakil, A., Anderson, S., Knapp, P. E., Hanka, S., Mohammed, N., Daou, P., Miciek, R., Ulloor, J., Zhang, A., Brooks, B., Orwoll, K., Hede-Brierley, L., Eder, R., Elmi, A., Bhasin, G., Collins, L., Singh, R., & Basaria, S.
- Affiliations
- Boston University (US)
- ORCID
- Venue
- JAMA
- Publisher
- American Medical Association (AMA)
- Published
- 2012-03-07
- Volume
- 307
- Issue
- 9
- Pages
- 931-9
- ISSN
- 0002-9955 (ISSN-L)
- 0098-7484
- PMC
- PMC6035750
- OpenAlex
- W2002514892
- Cited by
- 152
- References
- 58
- Citations by year
- 2026: 5 · 2025: 7 · 2024: 6 · 2023: 8 · 2022: 11 · 2021: 3 · 2020: 9 · 2019: 11 · 2018: 15 · 2017: 16 · 2016: 11 · 2015: 12 · 2014: 17 · 2013: 14 · 2012: 6
- FWCI
- 12.58
- Type
- journal article
- Language
- en
- Open access
- green
- europepmc.org
- Locations
- JAMA (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- Funders
- Eli Lilly and Company
- GlaxoSmithKline
- National Institutes of Health (5p30ag031679-15)
- Clinical and Translational Science Institute, Boston University
- National Institute on Aging (5 P30 AG031679, P30-AG031679)
- National Institute of Child Health and Human Development (1RO1HD043348)
- National Center for Research Resources (UL1RR025771)
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (R01HD043348)
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Hormonal and reproductive studies
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Adrenal Hormones and Disorders
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Prostate Cancer Treatment and Research
- Keywords
- testosterone supplementation, dutasteride, 5-alpha reductase inhibitors, dihydrotestosterone, fat-free mass, testosterone enanthate, muscle mass, muscle strength, sexual function, hematocrit, prostate volume, sebum production, serum lipids, androgen metabolism, healthy men, dose-response relationship
- MeSH terms
- Dutasteride, Adult, Azasteroids, Double-Blind Method, Hematocrit, Humans, Lipids, Male, Middle Aged, Prostate, Reproduction, Sebum, Testosterone, 3-Oxo-5-alpha-Steroid 4-Dehydrogenase, Body Mass Index, Treatment Outcome, Adiposity, Muscle Strength, 5-alpha Reductase Inhibitors
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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