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

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ClinicalTrials.gov Identifier: NCT01454011
Recruitment Status : Completed
First Posted : October 18, 2011
Last Update Posted : October 18, 2011
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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

Condition or disease Intervention/treatment Phase
Secondary Hypogonadism Drug: Testosteron 250mg injection Drug: Testosterone 50mg transdermal application Phase 4

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : September 2008
Primary Completion Date : February 2011
Study Completion Date : February 2011


Arms and Interventions

Arm Intervention/treatment
Active Comparator: Testosterone 250mg injection, 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.
Other Name: Sustanon 250 mg ampule
Active Comparator: Testosterone transdermal application Drug: Testosterone 50mg transdermal application
Application of testosterone 50mg transdermal gel in every night
Other Name: Testogel 50mg transdermal gel


Outcome Measures

Primary Outcome Measures :
  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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Congenital hypogonadotrophic hypogonadism,
  • Male sex

Exclusion Criteria:

  • Previous history of androgen replacement,
  • any chronic disorder
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01454011


Locations
Turkey
Gulhane School of Medicine
Ankara, Turkey, 06018
Sponsors and Collaborators
Gulhane School of Medicine
More Information

Responsible Party: Alper Sonmez, Associate Professor, Gulhane School of Medicine
ClinicalTrials.gov Identifier: NCT01454011     History of Changes
Other Study ID Numbers: GSM-012011
First Posted: October 18, 2011    Key Record Dates
Last Update Posted: October 18, 2011
Last Verified: October 2011

Keywords provided by Alper Sonmez, Gulhane School of Medicine:
hypogonadism
testosterone
HDL cholesterol subgroups
hsCRP
HOMA-IR

Additional relevant MeSH terms:
Hypogonadism
Gonadal Disorders
Endocrine System Diseases
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents