drugset / Trial / NCT00114114
Dose-Response of Gonadal Steroids and Bone Turnover in Older Men
Completed
177 enrolled
Massachusetts General Hospital
AbbVie · collabAstraZeneca · collabNational Institute on Aging (NIA) · collabSolvay Pharmaceuticals · collab
RandomizedParallel-groupSingle-blindDiagnostic
Summary
The purpose of this study is to determine the levels of testosterone and/or estradiol at which changes in bone turnover, body composition, strength, sexual function etc. begin to occur in older men. This information may help determine when to intervene with hormone replacement therapy in aging men.
Timeline
- Start
- 2004-09
- Primary completion
- 2017-11-01
- Completion
- 2017-11-01
Publications
- Finkelstein JS, Lee H, Burnett-Bowie SM, Darakananda K, Gentile EC, Goldstein DW, Prizand SH, Krivicich LM, Taylor AP, Wulczyn KE, Leder BZ, Yu EW. Dose-Response Relationships Between Gonadal Steroids and Bone, Body Composition, and Sexual Function in Aging Men. J Clin Endocrinol Metab. 2020 Aug 1;105(8):2779-88. doi: 10.1210/clinem/dgaa318.
- Bachmann KN, Huang S, Lee H, Dichtel LE, Gupta DK, Burnett JC Jr, Miller KK, Wang TJ, Finkelstein JS. Effect of Testosterone on Natriuretic Peptide Levels. J Am Coll Cardiol. 2019 Mar 26;73(11):1288-1296. doi: 10.1016/j.jacc.2018.12.062.
- Finkelstein JS, Lee H, Leder BZ, Burnett-Bowie SA, Goldstein DW, Hahn CW, Hirsch SC, Linker A, Perros N, Servais AB, Taylor AP, Webb ML, Youngner JM, Yu EW. Gonadal steroid-dependent effects on bone turnover and bone mineral density in men. J Clin Invest. 2016 Mar 1;126(3):1114-25. doi: 10.1172/JCI84137. Epub 2016 Feb 22.
- Finkelstein JS, Lee H, Burnett-Bowie SA, Pallais JC, Yu EW, Borges LF, Jones BF, Barry CV, Wulczyn KE, Thomas BJ, Leder BZ. Gonadal steroids and body composition, strength, and sexual function in men. N Engl J Med. 2013 Sep 12;369(11):1011-22. doi: 10.1056/NEJMoa1206168.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Goserelin | Other / unclassified | 3.6 g | Subcutaneous |
| Subject | Testosterone | Small molecule | 1.25 g | Topical |
| Subject | Testosterone | Small molecule | 2.5 g | Topical |
| Subject | Testosterone | Small molecule | 5 g | Topical |
| Subject | Testosterone | Small molecule | 7.5 g | Topical |
Indications
No indication recorded.