The Effect of Testosterone Replacement on the High Density Lipoprotein Cholesterol Subgroups

Study Overview
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Brief Summary
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The study is designed to answer the following questions: Is there any difference between the compositions of the HDL cholesterol subpopulations of patients with hypogonadism and the healthy controls. What is the effect of testosterone replacement therapy on the distributions of HDL subgroups. Is there any difference between the effects of the two different testosteron replacement regiments

Detailed Description
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This study has two designs: The case control design to search for the difference between the HDL subgroups and the other metabolic parameters between the healthy subjects and the patients with hypogonadism The follow-up study to search for the effects of two different testosterone replacement regiments.

Official Title
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Phase 4 Study That Compares the High Density Lipoprotein Cholesterol (HDL) Cholesterol Subgroups of the Patients With Congenital Hypogonadotrophic Hypogonadism With That of the Healthy Control Subjects, and Investigates the Effect of Testosterone Treatment on HDL Subgroups.

Conditions
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Secondary Hypogonadism

Intervention / Treatment
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* Drug: Testosteron 250mg injection
* Drug: Testosterone 50mg transdermal application


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Congenital hypogonadotrophic hypogonadism, Male sex Exclusion Criteria: Previous history of androgen replacement, any chronic disorder
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Testosterone 250mg injection,<br> | Drug: Testosteron 250mg injection<br>* The combination of 4 different testosterone esthers (30 mg testosterone propionate, 60 mg testosterone phenylpropionate, 60 mg testosterone isocaproate and 100 mg testosterone decanoate) injected in 3 weeks intervals.<br>* Other names: Sustanon 250 mg ampule;|
| Active Comparator: Testosterone transdermal application<br> | Drug: Testosterone 50mg transdermal application<br>* Application of testosterone 50mg transdermal gel in every night<br>* Other names: Testogel 50mg transdermal gel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the HDL cholesterol levels and the HDL subgroups | The HDL subfractions were measured by polyethylene glycol (PEG) precipitation technique. Two different reagents were prepared in different PEG concentrations and pH values. The supernatant of the solution precipitated with reagent A contained total HDL cholesterol while the supernatant of the solution precipitated with reagent B, contained only the HDL3 subclass. The cholesterol was then quantified by enzymatic with CHOD-PAP reagent (Olympus Diagnostics GmbH, Hamburg, Germany). HDL2 cholesterol was measured by calculating the difference between total HDL and the HDL3 subclass. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypogonadism, testosterone, HDL cholesterol subgroups, hsCRP, HOMA-IR