The Effect of Testosterone Replacement on Endothelial Dysfunction, Inflammation and Insulin Resistance in Male Hypogonadotrophic Hypogonadism
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|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|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|