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

Russian Academy of Medical Sciences1 site in 1 country250 target enrollmentOctober 2005

ConditionsMetabolic Syndrome Hypogonadism

InterventionsNebido (testosterone undecanoate)Placebo

DrugsNebido (testosterone undecanoate)Placebo

Overview

Phase: Phase 3
Intervention: Nebido (testosterone undecanoate)
Conditions: Metabolic Syndrome
Sponsor: Russian Academy of Medical Sciences
Enrollment: 250
Locations: 1
Primary Endpoint: waist-to-hip ratio
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

October 2005

End Date

December 2010

Last Updated

17 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Russian Academy of Medical Sciences

Eligibility Criteria

Inclusion Criteria

•A signed informed consent to participate in the study
•Men aged 35 to 70 with testosterone levels below 12 nmol/L or free testosterone below 225 pmol/L
•Presence of the metabolic syndrome according to the IDF definition

Exclusion Criteria

•Patients under 35 or above 70 years.
•Participation in any clinical study within 30 days before the first injection of the drug
•Simultaneous participation in another clinical study
•Incapable subjects as well as prisoners
•Suspicion of a serious organic or mental disease according to medical history and/or clinical examination
•Prostate cancer, breast cancer or suspicion thereof
•Presence or history of hepatic tumors
•Acute or chronic hepatic disease
•Presence of renal diseases with renal failure
•Changes in biochemical or hematological laboratory values in spite of lack of clinical manifestations, in the investigator's opinion