Back to resultsThe Effect of Testosterone Replacement on the High Density Lipoprotein Cholesterol Subgroups
Primary Purpose
Secondary Hypogonadism
Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Testosteron 250mg injection
Testosterone 50mg transdermal application
Sponsored by
About this trial
This is an interventional treatment trial for Secondary Hypogonadism focused on measuring hypogonadism, testosterone, HDL cholesterol subgroups, hsCRP, HOMA-IR
Eligibility Criteria
Inclusion Criteria:
- Congenital hypogonadotrophic hypogonadism,
- Male sex
Exclusion Criteria:
- Previous history of androgen replacement,
- any chronic disorder
Sites / Locations
- Gulhane School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Testosterone 250mg injection,
Testosterone transdermal application
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01454011
First Posted
October 12, 2011
Last Updated
October 14, 2011
Sponsor
Gulhane School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT01454011
Brief Title
The Effect of Testosterone Replacement on the High Density Lipoprotein Cholesterol Subgroups
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 Type
Interventional
2. Study Status
Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gulhane School of Medicine
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Secondary Hypogonadism
Keywords
hypogonadism, testosterone, HDL cholesterol subgroups, hsCRP, HOMA-IR
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Testosterone 250mg injection,
Arm Type
Active Comparator
Arm Title
Testosterone transdermal application
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Testosteron 250mg injection
Other Intervention Name(s)
Sustanon 250 mg ampule
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Testosterone 50mg transdermal application
Other Intervention Name(s)
Testogel 50mg transdermal gel
Intervention Description
Application of testosterone 50mg transdermal gel in every night
Primary Outcome Measure Information:
Title
Changes in the HDL cholesterol levels and the HDL subgroups
Description
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.
Time Frame
6 months
10. Eligibility
Sex
Male
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Congenital hypogonadotrophic hypogonadism,
Male sex
Exclusion Criteria:
Previous history of androgen replacement,
any chronic disorder
Facility Information:
Facility Name
Gulhane School of Medicine
City
Ankara
ZIP/Postal Code
06018
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
The Effect of Testosterone Replacement on the High Density Lipoprotein Cholesterol Subgroups
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