Study to Determine the Effects of Testosterone Replacement Therapy in Aging Men With Androgen Deficiency

Phase 2/3 Completed 44 enrolled Leonard S. Marks, M.D. Solvay Pharmaceuticals · collab Watson Pharmaceuticals · collab

RandomizedParallel-groupSingle-blindTreatment

Summary

The T-001 study is a placebo-controlled investigation of the effects of injectable testosterone replacement therapy on prostate tissues of aging men with low testosterone levels.

Timeline

Start: 2003-04
Primary completion: 2004-08
Completion: 2004-11

Publications

Marks LS, Mazer NA, Mostaghel E, Hess DL, Dorey FJ, Epstein JI, Veltri RW, Makarov DV, Partin AW, Bostwick DG, Macairan ML, Nelson PS. Effect of testosterone replacement therapy on prostate tissue in men with late-onset hypogonadism: a randomized controlled trial. JAMA. 2006 Nov 15;296(19):2351-61. doi: 10.1001/jama.296.19.2351.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Testosterone Enanthate	Small molecule	150 mg	Intramuscular

Indications

No indication recorded.