Efficacy of Testosterone Replacement Therapy in Correcting Anemia in Men With Hypogonadism: A Randomized Clinical Trial
An erratum to this article was published (JAMA Netw Open, 2 Jan 2024 ↗)
Authors' conclusion
In middle-aged and older men with hypogonadism and anemia, TRT was more efficacious than placebo in correcting anemia. Among men who were not anemic, a smaller proportion of testosterone-treated men developed anemia than placebo-treated men.
Study context
- Population
- Men aged 45 to 80 years with hypogonadism (2 testosterone <300 ng/dL, hypogonadal symptoms) and cardiovascular disease (CVD) or increased CVD risk, 316 US sites; 815 with anemia, 4379 without815 with anemia
- Participants
- 5,204 men
- Comparison
- 1.62% testosterone gel vs placebo gel daily
- Primary endpoint
- Proportion of participants with anemia (hemoglobin <12.7 g/dL) whose anemia remitted (hemoglobin ≥12.7 g/dL)
- Follow-up
- Over the study duration
Methodological detailsplacebo-controlled, multicentre, stratified for preexisting CVD, Enrolled May 2018 to February 2022; last visit January 2023
- Placebo-controlled
- Multicentre
- Stratified for preexisting CVD
- Enrolled May 2018 to February 2022; last visit January 2023
Primary result
As reported in the abstract
Anemia corrected · 6, 12, 24, 36 and 48 months
- 6 months: Testosterone vs Placebo
- 143 of 349 [41.0%] vs 103 of 375 [27.5%]
- 12 months: Testosterone vs Placebo
- 152 of 338 [45.0%] vs 122 of 360 [33.9%]
- 24 months: Testosterone vs Placebo
- 124 of 290 [42.8%] vs 95 of 307 [30.9%]
- 36 months: Testosterone vs Placebo
- 94 of 216 [43.5%] vs 76 of 229 [33.2%]
- 48 months: Testosterone vs Placebo
- 41 of 92 [44.6%] vs 38 of 97 [39.2%]
Secondary outcomes
Incidence of anemia among men without anemia
- Significantly smaller proportion of testosterone-treated men developed anemia than placebo-treated men
Hemoglobin and energy level
- Changes in hemoglobin were associated with changes in energy level
Original publication
Efficacy of Testosterone Replacement Therapy in Correcting Anemia in Men With Hypogonadism: A Randomized Clinical Trial. JAMA Netw Open. Published 2 October 2023. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →