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The Effect of Testosterone Replacement on Endothelial Dysfunction, Inflammation and Insulin Resistance in Male Hypogonadotrophic Hypogonadism

Information source: Gulhane School of Medicine
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypogonadotrophic Hypogonadism

Intervention: Testogel 50 mg transdermal gel (Drug); Testosterone 250mg injection (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Gulhane School of Medicine

Summary

The study searched for answers to two questions 1. What is the effect of testosterone replacement therapy on endothelial dysfunction, inflammation and insulin resistance? 2. Regarding the above parameters, is there any difference between daily transdermal testosterone implementation and intramuscular injection performed in three weeks.

Clinical Details

Official title: Phase 4 Study That Evaluates the Effects of Two Different Testosterone Replacement Regiments on Endothelial Dysfunction, Inflammation and Insulin Resistance in Male Subjects With Hypogonadotrophic Hypogonadism.

Study design: Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

The alterations in the measures for endothelial functions

The alterations in the measures of insulin resistance

The alterations in the measures of inflammation

Eligibility

Minimum age: 18 Years. Maximum age: 26 Years. Gender(s): Male.

Criteria:

Inclusion Criteria:

- Men

- Treatment naive

- Hypogonadotrophic hypogonadism

Exclusion Criteria:

- Previous history of androgen replacement

- Chronic metabolic disorders

Locations and Contacts

Gulhane School of Medicine Department of Endocrinology and Metabolism, Ankara, Non US 06018, Turkey
Additional Information

Starting date: August 2008
Last updated: February 14, 2012

Page last updated: August 23, 2015

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