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

Phase 4

Completed

• Conditions: Secondary Hypogonadism
• Interventions: Drug: Testosterone 50mg transdermal application; Drug: Testosteron 250mg injection

• Registration Number: NCT01454011
• Lead Sponsor: Gulhane School of Medicine

Brief 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

Detailed 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.

Study Timeline

• Study Start: 2008-09
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Status Verified: 2011-10
• Study First Submitted: 2011-10-12
• Study First Submitted QC: 2011-10-14
• Last Update Submitted: 2011-10-14
• Study First Posted: 2011-10-18
• Last Update Posted: 2011-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 140

Inclusion Criteria

• Congenital hypogonadotrophic hypogonadism,
• Male sex

Exclusion Criteria

• Previous history of androgen replacement,
• any chronic disorder

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Testosterone transdermal application	Testosterone 50mg transdermal application	-
Testosterone 250mg injection,	Testosteron 250mg injection	-

Primary Outcome Measures

Name	Time	Method
Changes in the HDL cholesterol levels and the HDL subgroups	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.

Trial Locations

Locations (1)

Gulhane School of Medicine; 🇹🇷 Ankara, Turkey