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NCT02111434 Clinical Trial

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

Hypogonadism Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02111434
Other study ID # GSM-022014
Secondary ID
Status Completed
Phase Phase 4
First received April 5, 2014
Last updated April 10, 2014
Start date July 2013
Est. completion date April 2014

Study information
Verified date April 2014
Source Gulhane School of Medicine
Contact n/a
Is FDA regulated No
Health authority Turkey: Ethics Committee
Study type Interventional

Clinical Trial Summary

The study is designed to answer the following questions:

1. What is the levels of visceral adiposity index and Triglycerides/HDL cholesterol ratio in hypogonadism?

2. What is the effect of testosterone replacement on the visceral adiposity index and Triglycerides/HDL cholesterol ratio?

Description:

This is a retrospective design, which is performed by investigating the registrations of patients with hypogonadotrophic hypogonadism between the years 2007-2010.

Recruitment information / eligibility
Status Completed
Enrollment 150
Est. completion date April 2014
Est. primary completion date April 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 26 Years
Eligibility Inclusion Criteria:

- Men

- Congenital hypogonadism

- Treatment Naive

Exclusion Criteria:

- Previous history of androgen replacement

- Hypertension

- Diabetes mellitus

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

Intervention

Drug:
• Testosterone
Testosterone 250 mg injection per 3-4 weeks for 6 months

Locations
Country Name City State
Turkey Gulhane School of Medicine Ankara

Sponsors (1)
Lead Sponsor Collaborator
Gulhane School of Medicine

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary time to change of visceral adiposity index with testosteron replacement baseline and 6 months No
Primary time to change of TG/HDL cholesterol ratio with testosteron replacement baseline and 6 months No
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