The Effect of Testosterone Replacement on the High Density Lipoprotein Cholesterol Subgroups
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|ClinicalTrials.gov Identifier: NCT01454011|
Recruitment Status : Completed
First Posted : October 18, 2011
Last Update Posted : October 18, 2011
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
|Condition or disease||Intervention/treatment||Phase|
|Secondary Hypogonadism||Drug: Testosteron 250mg injection Drug: Testosterone 50mg transdermal application||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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.|
|Study Start Date :||September 2008|
|Actual Primary Completion Date :||February 2011|
|Actual Study Completion Date :||February 2011|
|Active Comparator: Testosterone 250mg injection,||
Drug: Testosteron 250mg injection
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.
Other Name: Sustanon 250 mg ampule
|Active Comparator: Testosterone transdermal application||
Drug: Testosterone 50mg transdermal application
Application of testosterone 50mg transdermal gel in every night
Other Name: Testogel 50mg transdermal gel
- Changes in the HDL cholesterol levels and the HDL subgroups [ Time Frame: 6 months ]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.
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): NCT01454011
|Gulhane School of Medicine|
|Ankara, Turkey, 06018|