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”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: January 2009

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Men receiving Nebido
• Placebo Comparator: 2
  • Men receiving Placebo

Primary Measures

• waist-to-hip ratio
  • Time Frame: 3 years
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 35 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Russian Academy of Medical Sciences

Overall Clinical Trial Officials and Contacts

Svetlana Kalinchenko, PhD Principal Investigator Scientific Center for Endocrinology, Russia  

Overall Contact: Svetlana Kalinchenko, PhD +70951244301 kalinchenko@list.ru

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00696748

Study ID Number: U00006KO

ClinicalTrials.gov Identifier: NCT00696748

Health Authority: Russia: Pharmacological Committee, Ministry of Health