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

Gulhane School of Medicine

Status and phase: Completed; Phase 4

Conditions: Secondary Hypogonadism

Treatments: Drug: Testosteron 250mg injection; Drug: Testosterone 50mg transdermal application

Study type: Interventional

Funder types: Other

Identifiers

NCT01454011

GSM-012011

Details and patient eligibility

About

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

Full 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.

Enrollment: 140 patients

Sex: Male

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Congenital hypogonadotrophic hypogonadism,
• Male sex

Exclusion criteria

• Previous history of androgen replacement,
• any chronic disorder

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

Testosterone 250mg injection,

Active Comparator group

Treatment:

Drug: Testosteron 250mg injection

Testosterone transdermal application

Active Comparator group

Treatment:

Drug: Testosterone 50mg transdermal application