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

Hypogonadotrophic Hypogonadism Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01533129
• Other study ID #: GSM-022011
• Status: Completed
• Phase: Phase 4
• Start date: August 2008

Study information

• Verified date: July 2020
• Source: Gulhane School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 26 Years

Eligibility

Inclusion Criteria:

• Men

• Treatment naive

• Hypogonadotrophic hypogonadism

Exclusion Criteria:

• Previous history of androgen replacement

• Chronic metabolic disorders

Related Conditions & MeSH terms

• Hypogonadism
• Hypogonadotrophic Hypogonadism
• Inflammation
• Insulin Resistance

Intervention

Drug:
• Testogel 50 mg transdermal gel
50mg testosterone gel implementation on every night
• Testosterone 250mg injection
The testosterone 250mg ester IM injections performed in three weeks.

Locations

Country	Name	City	State
Turkey	Gulhane School of Medicine Department of Endocrinology and Metabolism	Ankara	Non US

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	The alterations in the measures for endothelial functions	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.	6 months
Primary	The alterations in the measures of insulin resistance	The alterations in insulin sensitivity are estimated by using the HOMA index by the formula, HOMA-IR = (insulin x glucose)/405.	6 months
Primary	The alterations in the measures of inflammation	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.	6 months