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...
Brief Summary
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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
- 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
Outcome Measures for this Clinical Trial
Primary Measures
- waist-to-hip ratio
- Time Frame: 3 years
Safety Issue?: No
- Time Frame: 3 years
Criteria for Participation in this Clinical Trial
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
Clinical Trial Investigator Information
Lead Investigator: Russian Academy of Medical Sciences Other
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
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
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
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00696748
