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

Phase 3

• Conditions: Metabolic Syndrome; Hypogonadism
• Interventions: Drug: Nebido (testosterone undecanoate); Drug: Placebo

• Registration Number: NCT00696748
• Lead Sponsor: Russian Academy of Medical Sciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10
• Status Verified: 2008-06
• Study First Submitted: 2008-06-11
• Study First Submitted QC: 2008-06-11
• Last Update Submitted: 2008-06-11
• Study First Posted: 2008-06-13
• Last Update Posted: 2008-06-13
• Primary Completion: 2009-01
• Study Completion: 2010-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 250

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
• Suspected lack of the patient's compliance
• Hypersensitivity to the active substance

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Nebido (testosterone undecanoate)	Men receiving Nebido
2	Placebo	Men receiving Placebo

Primary Outcome Measures

Name	Time	Method
waist-to-hip ratio	3 years

Trial Locations

Locations (1)

Scientific Centre for Endocrinology RAMS; 🇷🇺 Moscow, Russian Federation