| Trial ID: | L3563 |
| Source ID: | NCT00350701
|
| Associated Drug: |
Androgel
|
| Title: |
Effect of Androgel on Type 2 Diabetic Males With Hypogonadism
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00350701/results
|
| Conditions: |
Diabetes Mellitus Type 2
|
| Interventions: |
DRUG: androgel|DRUG: androgel 10g|DRUG: placebo
|
| Outcome Measures: |
Primary: Effect of Androgel Treatment on Relative Nuclear Factor kB Activity Compared to Placebo, To measure the percent change from baseline at 8 weeks in Nuclear Factor kB DNA binding activity (in arbitrary units normalized to 100% at baseline) between AndroGel and Placebo using electrophoretic mobility shift assay (EMSA). Values at 8 weeks are converted to percent change and compared between the groups, 8 weeks | Secondary: Effect of Androgel Treatment on Reactive Oxygen Species Generation Compared to Placebo, Comparison of relative percent change from baseline at 8 weeks in reactive oxygen species generation (measured as arbitrary units normalized to 100% at baseline) in mononuclear cells after either AndroGel or placebo using chemiluminescence PMSF activation assay. Values at 8 weeks are converted to percentage of the baseline and compared between the groups, 8 weeks|Change in Inflammatory Mediator C-Reactive Protein (CRP) Following Treatment With Testosterone, To measure the relative percent change from baseline in the inflammatory mediator (CRP) at 8 weeks (values in ng/ml normalized to100% at baseline) following treatment with androgel compared to placebo. Values (in ng/ml) are converted to percentage of baseline at 8 weeks., 8 week
|
| Sponsor/Collaborators: |
Sponsor: University at Buffalo | Collaborators: Solvay Pharmaceuticals
|
| Gender: |
MALE
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
49
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: DIAGNOSTIC
|
| Start Date: |
2006-07
|
| Completion Date: |
2013-07
|
| Results First Posted: |
2022-02-10
|
| Last Update Posted: |
2022-02-10
|
| Locations: |
Diabetes-Endocrinology Center of Western NY, 115 flint road, Buffalo, New York, 14221, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00350701
|
