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

Condition(s) targeted: Secondary Hypogonadism

Intervention: Testosteron 250mg injection (Drug); Testosterone 50mg transdermal application (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Gulhane School of Medicine

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

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

Primary outcome: Changes in the HDL cholesterol levels and the HDL subgroups

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.

Minimum age: N/A. Maximum age: N/A. Gender(s): Male.

Criteria:

Inclusion Criteria:

- Congenital hypogonadotrophic hypogonadism,

- Male sex

Exclusion Criteria:

- Previous history of androgen replacement,

- any chronic disorder

Gulhane School of Medicine, Ankara 06018, Turkey

Starting date: September 2008
Last updated: October 14, 2011