drugset / Trial / NCT00475501
5-Alpha Reductase and Anabolic Effects of Testosterone
Phase 2
Completed
60 enrolled
VA Office of Research and Development
Endo USA Inc., a Keenova Therapeutics Company · collabMerck Sharp & Dohme LLC · collab
RandomizedFactorialTriple-blindTreatment
Summary
The purpose of this study is to determine whether a higher-than-replacement dose of testosterone and finasteride can be combined to safely increase muscle strength in older men who have a low blood concentration of testosterone.
Timeline
- Start
- 2007-01
- Primary completion
- 2012-03
- Completion
- 2014-10
Outcome
Met primary endpoint
registry analysis (superiority or other test); Arm 1 vs Arm 2 vs Arm 3 vs Arm 4; p <0.001; Mean Difference (Net) 12.9 (95% CI 7.86 to 18.0) NCT00475501 ↗
paper Over the course of 12 mo, TE increased upper and lower body muscle strength by 8-14% (P = 0.015 to <0.001) PMID 24326421 ↗
Publications
- Results Yarrow JF, Beck DT, Conover CF, Beggs LA, Goldberger BA, Borst SE. Invalidation of a commercially available human 5alpha-dihydrotestosterone immunoassay. Steroids. 2013 Dec 11;78(12-13):1220-5. doi: 10.1016/j.steroids.2013.08.013. Epub 2013 Sep 6.
- Results Borst SE, Yarrow JF, Conover CF, Nseyo U, Meuleman JR, Lipinska JA, Braith RW, Beck DT, Martin JS, Morrow M, Roessner S, Beggs LA, McCoy SC, Cannady DF 2nd, Shuster JJ. Musculoskeletal and prostate effects of combined testosterone and finasteride administration in older hypogonadal men: a randomized, controlled trial. Am J Physiol Endocrinol Metab. 2014 Feb 15;306(4):E433-42. doi: 10.1152/ajpendo.00592.2013. Epub 2013 Dec 10.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Finasteride | Small molecule | 5 mg | Oral |
| Subject | Testosterone Enanthate | Small molecule | 125 mg | Intramuscular |