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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alper Sonmez, Gulhane School of Medicine
ClinicalTrials.gov Identifier:
NCT01454011
First received: October 12, 2011
Last updated: October 14, 2011
Last verified: October 2011
  Purpose

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 Intervention Phase
Secondary Hypogonadism
Drug: Testosteron 250mg injection
Drug: Testosterone 50mg transdermal application
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Gulhane School of Medicine:

Primary Outcome Measures:
  • Changes in the HDL cholesterol levels and the HDL subgroups [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 140
Study Start Date: September 2008
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01454011

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

No publications provided

Responsible Party: Alper Sonmez, Associate Professor, Gulhane School of Medicine
ClinicalTrials.gov Identifier: NCT01454011     History of Changes
Other Study ID Numbers: GSM-012011
Study First Received: October 12, 2011
Last Updated: October 14, 2011
Health Authority: Turkey: Ethics Committee

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

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

ClinicalTrials.gov processed this record on November 20, 2014