The Effect of Testosterone Replacement on Endothelial Dysfunction, Inflammation and Insulin Resistance in Male Hypogonadotrophic Hypogonadism
|ClinicalTrials.gov Identifier: NCT01533129|
Recruitment Status : Completed
First Posted : February 15, 2012
Last Update Posted : February 15, 2012
The study searched for answers to two questions
- What is the effect of testosterone replacement therapy on endothelial dysfunction, inflammation and insulin resistance?
- Regarding the above parameters, is there any difference between daily transdermal testosterone implementation and intramuscular injection performed in three weeks.
|Condition or disease||Intervention/treatment||Phase|
|Hypogonadotrophic Hypogonadism||Drug: Testogel 50 mg transdermal gel Drug: Testosterone 250mg injection||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||106 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 4 Study That Evaluates the Effects of Two Different Testosterone Replacement Regiments on Endothelial Dysfunction, Inflammation and Insulin Resistance in Male Subjects With Hypogonadotrophic Hypogonadism.|
|Study Start Date :||August 2008|
|Primary Completion Date :||April 2011|
|Active Comparator: Daily testosterone transdermal gel||
Drug: Testogel 50 mg transdermal gel
50mg testosterone gel implementation on every night
Other Name: Testogel 50mg transdermal gel
Active Comparator: Injectable Testosterone esters
Testosteron 250mg injection per 3-4 weeks for 6 months
Drug: Testosterone 250mg injection
The testosterone 250mg ester IM injections performed in three weeks.
Other Name: Sustanon 250 mg amp.
- The alterations in the measures for endothelial functions [ Time Frame: 6 months ]The alterations in Endothelial functions are determined by measuring plazma ADMA levels, as a surrogate. ADMA measurement is pereformed by ELISA kit (Immundiagnotik, Bensheim, Germany)(Catalog Number 7828) with a minimal detection limit of 0.05µmol/L.
- The alterations in the measures of insulin resistance [ Time Frame: 6 months ]The alterations in insulin sensitivity are estimated by using the HOMA index by the formula, HOMA-IR = (insulin x glucose)/405.
- The alterations in the measures of inflammation [ Time Frame: 6 months ]The alterations in the measures of inflammation are determined by measuring Human Pentraxin-3 levels. ELISA kiti /R&D Systems, Inc. Minneapolis, MN, ABD) (Catalog number DPTX30) with a minimal detection limit of 0.025ng/ml, intraassay CV of 3.8-4.4%, and interassay CV of 4.1-6.1% was used.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01533129
|Gulhane School of Medicine Department of Endocrinology and Metabolism|
|Ankara, Non US, Turkey, 06018|