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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alper Sonmez, Gulhane School of Medicine
ClinicalTrials.gov Identifier:
NCT01533129
First received: December 13, 2011
Last updated: February 14, 2012
Last verified: February 2012
History of Changes
  Purpose

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.

Condition Intervention Phase
Hypogonadotrophic Hypogonadism
 Drug: Testogel 50 mg transdermal gel
Drug: Testosterone 250mg injection
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Gulhane School of Medicine:

Primary Outcome Measures:
  • The alterations in the measures for endothelial functions [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 106
Study Start Date: August 2008
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Daily testosterone transdermal gel Drug: Testogel 50 mg transdermal gel
50mg testosterone gel implementation on every night
Other Name: 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 Name: Sustanon 250 mg amp.

  Eligibility

Ages Eligible for Study:   18 Years to 26 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men
  • Treatment naive
  • Hypogonadotrophic hypogonadism

Exclusion Criteria:

  • Previous history of androgen replacement
  • Chronic metabolic disorders
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01533129

Locations
Turkey
Gulhane School of Medicine Department of Endocrinology and Metabolism
Ankara, Non US, Turkey, 06018
Sponsors and Collaborators
Gulhane School of Medicine
  More Information

No publications provided

Responsible Party: Alper Sonmez, Associate Professor in Medicine, Gulhane School of Medicine
ClinicalTrials.gov Identifier: NCT01533129     History of Changes
Other Study ID Numbers: GSM-022011
Study First Received: December 13, 2011
Last Updated: February 14, 2012
Health Authority: Turkey: Central Ethical Committee

Keywords provided by Gulhane School of Medicine:
Hypogonadism
Endothelial dysfunction
Inflammation
Insulin resistance
Testosterone replacement therapy

Additional relevant MeSH terms:
Hypogonadism
Inflammation
Insulin Resistance
Gonadal Disorders
Endocrine System Diseases
Pathologic Processes
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
 Methyltestosterone
Insulin
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents
Hypoglycemic Agents

ClinicalTrials.gov processed this record on May 19, 2013