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Completed

NCT Number: NCT01454011

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

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

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Key information

Conditions

Secondary Hypogonadism Endocrine System Diseases Gonadal Disorders Hypogonadism

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Gulhane School of Medicine

Ankara, 06018, Turkey (Türkiye)

About this study

This study has two designs:

  • 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
  • The follow-up study to search for the effects of two different testosterone replacement regiments.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Congenital hypogonadotrophic hypogonadism,
  • Male sex

Exclusion criteria

  • Previous history of androgen replacement,
  • any chronic disorder

Treatment and study plan

Testosteron 250mg injection

Drug

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.

Other names: Sustanon 250 mg ampule

Testosterone 50mg transdermal application

Drug

Application of testosterone 50mg transdermal gel in every night

Other names: Testogel 50mg transdermal gel

Primary outcomes

  1. Changes in the HDL cholesterol levels and the HDL subgroups

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Gulhane School of Medicine

Other

Registry information

Official study 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.

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Oct 18, 2011
Registry last updated
Oct 18, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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