NCT01454011

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

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.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Gulhane School of Medicine · Academic / Other
• Sex: Male
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

• Secondary Hypogonadism

Interventions

Type	Name	Description
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.
DRUG	Testosterone 50mg transdermal application	Application of testosterone 50mg transdermal gel in every night

Timeline

• Start date: 2008-09-01
• Primary completion: 2011-02-01
• Completion: 2011-02-01
• First posted: 2011-10-18
• Last updated: 2011-10-18

Locations

1 site across 1 country: Turkey (Türkiye)