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

Metabolic Syndrome Clinical Trial

— NePlaM3  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00696748
• Other study ID #: U00006KO
• Status: Recruiting
• Phase: Phase 3
• First received: June 11, 2008
• Last updated: June 11, 2008
• Start date: October 2005
• Est. completion date: December 2010

Study information

• Verified date: June 2008
• Source: Russian Academy of Medical Sciences
• Contact: Svetlana Kalinchenko, PhD
• Phone: +70951244301
• Email: kalinchenko[@]list.ru
• Is FDA regulated: No
• Health authority: Russia: Pharmacological Committee, Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 2010
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 35 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypogonadism
• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

Drug:
• Nebido (testosterone undecanoate)
Nebido (testosterone undecanoate) intramuscular 4 ml by scheme
• Placebo
Placebo 4 mL intramuscular

Locations

Country	Name	City	State
Russian Federation	Scientific Centre for Endocrinology RAMS	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Russian Academy of Medical Sciences

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	waist-to-hip ratio		3 years	No