NCT01092858

NEBIDO in Symptomatic Late Onset Hypogonadism (SLOH)

Effect of Exercise Alone or in Combination With Testosterone Replacement on Muscle Strength and Quality of Life in Older Men With Low Testosterone Concentrations: a Randomized Double-blind, Placebo Controlled Study

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Bayer · Industry
• Sex: Male
• Age: 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypogonadism

Interventions

Type	Name	Description
DRUG	Testosterone Undeconate (Nebido, BAY86-5037)	Testosterone undecanoate 1000 mg (4 ml) i.m. injection at baseline, at week 6, at week 18, at week 30 and at week 42, respectively
DRUG	Placebo	Matching placebo i.m. injections at baseline, at week 6, at week 18 at week 30 and at week 42, respectively

Timeline

• Start date: 2010-09-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2010-03-25
• Last updated: 2014-11-05

Locations

1 site across 1 country: Germany