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

Secondary Hypogonadism Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01454011
• Other study ID #: GSM-012011
• 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

• Hypogonadism
• Secondary Hypogonadism

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