NCT00696748

The Effect of IM Testosterone Undecanoate on Biochemical and Anthropometric Characteristics of Metabolic Syndrome in Hypogonadal Men

A Randomized, Placebo-Controlled, Double-Blind, Parallel Group Study With Open-Label Follow-up to Investigate the Effect of IM Testosterone Undecanoate on Biochemical and Anthropometric Characteristics of Metabolic Syndrome in Hypogonadal Men

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Russian Academy of Medical Sciences · Academic / Other
• Sex: Male
• Age: 35 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The objective of the study is to assess the effect of the testosterone therapy on the body composition, lipid and glucose metabolism, inflammatory markers in patients with metabolic syndrome and hypogonadism.

Conditions

• Metabolic Syndrome
• Hypogonadism

Interventions

Type	Name	Description
DRUG	Nebido (testosterone undecanoate)	Nebido (testosterone undecanoate) intramuscular 4 ml by scheme
DRUG	Placebo	Placebo 4 mL intramuscular

Timeline

• Start date: 2005-10-01
• Primary completion: 2009-01-01
• Completion: 2010-12-01
• First posted: 2008-06-13
• Last updated: 2008-06-13

Locations

1 site across 1 country: Russia