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

NCT00696748 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2008-06-13

No results posted yet for this study

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

DRUG

Nebido (testosterone undecanoate)

Nebido (testosterone undecanoate) intramuscular 4 ml by scheme

DRUG

Placebo

Placebo 4 mL intramuscular

Sponsors & Collaborators

  • Russian Academy of Medical Sciences

    lead OTHER

Principal Investigators

  • Svetlana Kalinchenko, PhD · Scientific Center for Endocrinology, Russia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
70 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-10-31
Primary Completion
2009-01-31
Completion
2010-12-31

Countries

  • Russia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00696748 on ClinicalTrials.gov