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

July 21, 2020 updated by: Alper Sonmez, Gulhane School of Medicine

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

106

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 26 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Men
  • Treatment naive
  • Hypogonadotrophic hypogonadism

Exclusion Criteria:

  • Previous history of androgen replacement
  • Chronic metabolic disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Daily testosterone transdermal gel
Drug: Testogel 50 mg transdermal gel
50mg testosterone gel implementation on every night
Other Names:
  • Testogel 50mg transdermal gel
ACTIVE_COMPARATOR: Injectable Testosterone esters
Testosteron 250mg injection per 3-4 weeks for 6 months
Drug: Testosterone 250mg injection
The testosterone 250mg ester IM injections performed in three weeks.
Other Names:
  • Sustanon 250 mg amp.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gulhane School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (ACTUAL)

April 1, 2011

Study Registration Dates

First Submitted

December 13, 2011

First Submitted That Met QC Criteria

February 14, 2012

First Posted (ESTIMATE)

February 15, 2012

Study Record Updates

Last Update Posted (ACTUAL)

July 22, 2020

Last Update Submitted That Met QC Criteria

July 21, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GSM-022011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypogonadotrophic Hypogonadism

Clinical Trials on Testogel 50 mg transdermal gel

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Georgia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe