Endothelial Dysfunction, Inflammation and Insulin Resistance in Congenital Hypogonadism and Effect of Testosteron Replacement Therapy

June 20, 2014 updated by: Alper Sonmez, Gulhane School of Medicine

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

The study searched for answers to two questions

  1. Is there endothelial dysfunction, inflammation and insulin resistance in patients with congenital hypogonadotropic hypogonadism?
  2. What is the effect of testosterone replacement therapy on endothelial dysfunction, inflammation and insulin resistance?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

130

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
    • NonUS
      • Ankara, NonUS, 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

Yes

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Daily testosterone transdermal gel
Drug: Testosteron 50 mg transdermal gel
50mg testosterone gel implemented 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 intramuscular 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 plasma asymmetric dimethylarginine (ADMA) levels, as a surrogate. ADMA measurement is performed by ELISA kit (Immunodiagnostic, Bernheim, Germany)(Catalog Number 7828) with a minimal detection limit of 0.05µmol/L.
6 months
The alterations in the measures of inflammation
Time Frame: 6 months
The alterations in the measures of inflammation are determined by measuring plasma TWEAK levels. ELISA kit (Bender MedSystems, Lot Nr.BMS2006INST, Vienna, Austria) was used.
6 months
The alterations in the measures of insulin resistance
Time Frame: 6 months.
The alterations in insulin sensitivity are estimated by using the homeostasis model assessment (HOMA) index by the formula, HOMA = (insulin x glucose)/405.
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)

June 1, 2012

Study Registration Dates

First Submitted

June 20, 2014

First Submitted That Met QC Criteria

June 20, 2014

First Posted (Estimate)

June 24, 2014

Study Record Updates

Last Update Posted (Estimate)

June 24, 2014

Last Update Submitted That Met QC Criteria

June 20, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GSM-042014

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.

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