The Effect of IM Testosterone Undecanoate on Biochemical and Anthropometric Characteristics of Metabolic Syndrome in Hypogonadal Men (NePlaM3)
Tracking Information
Start Date ICMJE | October 2005 |
---|---|
Estimated Primary Completion Date | January 2009 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: June 11, 2008) | waist-to-hip ratio [ Time Frame: 3 years ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures ICMJE | Same as current |
Change History | No Changes Posted |
Descriptive Information
Brief Title ICMJE | The Effect of IM Testosterone Undecanoate on Biochemical and Anthropometric Characteristics of Metabolic Syndrome in Hypogonadal Men |
---|---|
Official Title ICMJE | 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 |
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 | |
Study Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Condition ICMJE |
|
Intervention ICMJE |
|
Study Arms / Comparison Groups |
|
Recruitment Information
Estimated Enrollment ICMJE | 250 | ||||||||
---|---|---|---|---|---|---|---|---|---|
Estimated Completion Date | December 2010 | ||||||||
Estimated Primary Completion Date | January 2009 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| ||||||||
Gender | Male | ||||||||
Ages | 35 Years to 70 Years | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts ICMJE |
| ||||||||
Location Countries ICMJE | Russian Federation |
Administrative Information
Source: http://clinicaltrials.gov/