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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01454011
Other study ID # GSM-012011
Secondary ID
Status Completed
Phase Phase 4
First received October 12, 2011
Last updated October 14, 2011
Start date September 2008
Est. completion date February 2011

Study information

Verified date October 2011
Source Gulhane School of Medicine
Contact n/a
Is FDA regulated No
Health authority Turkey: Ethics Committee
Study type Interventional

Clinical Trial Summary

The study is designed to answer the following questions:

1. Is there any difference between the compositions of the HDL cholesterol subpopulations of patients with hypogonadism and the healthy controls.

2. What is the effect of testosterone replacement therapy on the distributions of HDL subgroups.

3. Is there any difference between the effects of the two different testosteron replacement regiments


Description:

This study has two designs:

1. 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

2. The follow-up study to search for the effects of two different testosterone replacement regiments.


Recruitment information / eligibility

Status Completed
Enrollment 140
Est. completion date February 2011
Est. primary completion date February 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group N/A and older
Eligibility Inclusion Criteria:

- Congenital hypogonadotrophic hypogonadism,

- Male sex

Exclusion Criteria:

- Previous history of androgen replacement,

- any chronic disorder

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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.
Testosterone 50mg transdermal application
Application of testosterone 50mg transdermal gel in every night

Locations

Country Name City State
Turkey Gulhane School of Medicine Ankara

Sponsors (1)

Lead Sponsor Collaborator
Gulhane School of Medicine

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
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