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Visceral Adiposity Index and Triglyceride/High-density Lipoprotein Cholesterol Ratio in the Congenital Hypogonadotropic Hypogonadism and Effect of Testosteron Treatment

Primary Purpose

Hypogonadism

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Testosterone
Sponsored by
Gulhane School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Hypogonadism focused on measuring visceral adiposity index, triglycerides / hdl cholesterol ratio, testosterone

Eligibility Criteria

18 Years - 26 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Men
  • Congenital hypogonadism
  • Treatment Naive

Exclusion Criteria:

  • Previous history of androgen replacement
  • Hypertension
  • Diabetes mellitus

Sites / Locations

  • Gulhane School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

testosterone

Arm Description

testosterone gel per day for 6 months testosterone 250 mg injection per 3-4 weeks for 6 months

Outcomes

Primary Outcome Measures

time to change of visceral adiposity index with testosteron replacement
time to change of TG/HDL cholesterol ratio with testosteron replacement

Secondary Outcome Measures

Full Information

First Posted
April 5, 2014
Last Updated
April 10, 2014
Sponsor
Gulhane School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02111434
Brief Title
Visceral Adiposity Index and Triglyceride/High-density Lipoprotein Cholesterol Ratio in the Congenital Hypogonadotropic Hypogonadism and Effect of Testosteron Treatment
Official Title
Phase 4 Study of Effect of Testosteron Treatment on the Visceral Adiposity Index and Triglyceride/High-density Lipoprotein Cholesterol Ratio in the Congenital Hypogonadotropic Hypogonadism
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gulhane School of Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The study is designed to answer the following questions: What is the levels of visceral adiposity index and Triglycerides/HDL cholesterol ratio in hypogonadism? What is the effect of testosterone replacement on the visceral adiposity index and Triglycerides/HDL cholesterol ratio?
Detailed Description
This is a retrospective design, which is performed by investigating the registrations of patients with hypogonadotrophic hypogonadism between the years 2007-2010.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypogonadism
Keywords
visceral adiposity index, triglycerides / hdl cholesterol ratio, testosterone

7. Study Design

Primary Purpose
Screening
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
testosterone
Arm Type
Experimental
Arm Description
testosterone gel per day for 6 months testosterone 250 mg injection per 3-4 weeks for 6 months
Intervention Type
Drug
Intervention Name(s)
Testosterone
Other Intervention Name(s)
sustanon 250 mg
Intervention Description
Testosterone 250 mg injection per 3-4 weeks for 6 months
Primary Outcome Measure Information:
Title
time to change of visceral adiposity index with testosteron replacement
Time Frame
baseline and 6 months
Title
time to change of TG/HDL cholesterol ratio with testosteron replacement
Time Frame
baseline and 6 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
26 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Men Congenital hypogonadism Treatment Naive Exclusion Criteria: Previous history of androgen replacement Hypertension Diabetes mellitus
Facility Information:
Facility Name
Gulhane School of Medicine
City
Ankara
ZIP/Postal Code
06018
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

Visceral Adiposity Index and Triglyceride/High-density Lipoprotein Cholesterol Ratio in the Congenital Hypogonadotropic Hypogonadism and Effect of Testosteron Treatment

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