The Effect of Testosterone Replacement on Endothelial Dysfunction, Inflammation and Insulin Resistance in Male Hypogonadotrophic Hypogonadism

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Hypogonadotrophic Hypogonadism

Intervention / Treatment
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* Drug: Testogel 50 mg transdermal gel
* Drug: Testosterone 250mg injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men Treatment naive Hypogonadotrophic hypogonadism Exclusion Criteria: Previous history of androgen replacement Chronic metabolic disorders

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 26 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Daily testosterone transdermal gel<br> | Drug: Testogel 50 mg transdermal gel<br>* 50mg testosterone gel implementation on every night<br>* Other names: Testogel 50mg transdermal gel;|
| Active Comparator: Injectable Testosterone esters<br>Testosteron 250mg injection per 3-4 weeks for 6 months | Drug: Testosterone 250mg injection<br>* The testosterone 250mg ester IM injections performed in three weeks.<br>* Other names: Sustanon 250 mg amp.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The alterations in the measures for endothelial functions | 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. | 6 months | 
| The alterations in the measures of insulin resistance | The alterations in insulin sensitivity are estimated by using the HOMA index by the formula, HOMA-IR = (insulin x glucose)/405. | 6 months | 
| The alterations in the measures of inflammation | 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. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypogonadism, Endothelial dysfunction, Inflammation, Insulin resistance, Testosterone replacement therapy