drugset / Trial / NCT01092858

NEBIDO in Symptomatic Late Onset Hypogonadism (SLOH)

NCT01092858

Phase 4 Terminated 4 enrolled Bayer
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The design of the study is a standard double-blind design, which is needed in this study to allow for unbiased evaluation of efficacy and safety. The effect of the additional impact of testosterone replacement therapy in hypogonadal men on muscle strength and quality of life in comparison to physical exercise alone will be assessed. Treatment duration will be 54 weeks, to monitor the increase as well as the "steady state" of the parameters assessed.

Timeline

Start
2010-09
Primary completion
2011-07
Completion
2011-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Testosterone Undecanoate Small molecule 1000 mg Intramuscular

Indications