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

Phase 4

Completed

• Conditions: Hypogonadotrophic Hypogonadism
• Interventions: Drug: Testogel 50 mg transdermal gel; Drug: Testosterone 250mg injection

• Registration Number: NCT01533129
• Lead Sponsor: Gulhane School of Medicine

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Primary Completion: 2011-04
• Study First Submitted: 2011-12-13
• Study First Submitted QC: 2012-02-14
• Study First Posted: 2012-02-15
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-21
• Last Update Posted: 2020-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 106

Inclusion Criteria

• Men
• Treatment naive
• Hypogonadotrophic hypogonadism

Exclusion Criteria

• Previous history of androgen replacement
• Chronic metabolic disorders

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Daily testosterone transdermal gel	Testogel 50 mg transdermal gel	-
Injectable Testosterone esters	Testosterone 250mg injection	Testosteron 250mg injection per 3-4 weeks for 6 months

Primary Outcome Measures

Name	Time	Method
The alterations in the measures for endothelial functions	6 months	The alterations in Endothelial functions are determined by measuring plazma ADMA levels, as a surrogate. ADMA measurement is pereformed by ELISA kit (Immundiagnotik, Bensheim, Germany)(Catalog Number 7828) with a minimal detection limit of 0.05µmol/L.
The alterations in the measures of insulin resistance	6 months	The alterations in insulin sensitivity are estimated by using the HOMA index by the formula, HOMA-IR = (insulin x glucose)/405.
The alterations in the measures of inflammation	6 months	The alterations in the measures of inflammation are determined by measuring Human Pentraxin-3 levels. ELISA kiti /R\&D Systems, Inc. Minneapolis, MN, ABD) (Catalog number DPTX30) with a minimal detection limit of 0.025ng/ml, intraassay CV of 3.8-4.4%, and interassay CV of 4.1-6.1% was used.

Trial Locations

Locations (1)

Gulhane School of Medicine Department of Endocrinology and Metabolism; 🇹🇷 Ankara, Non US, Turkey