Status:
UNKNOWN
The Effect of IM Testosterone Undecanoate on Biochemical and Anthropometric Characteristics of Metabolic Syndrome in Hypogonadal Men
Lead Sponsor:
Russian Academy of Medical Sciences
Conditions:
Metabolic Syndrome
Hypogonadism
Eligibility:
MALE
35-70 years
Phase:
PHASE3
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 hypog...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2010
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT00696748
Start Date
October 1 2005
End Date
December 1 2010
Last Update
June 13 2008
Active Locations (1)
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1
Scientific Centre for Endocrinology RAMS
Moscow, Russia, 117136