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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.
Information provided by (Responsible Party):
Alper Sonmez, Gulhane School of Medicine Identifier:
First received: December 13, 2011
Last updated: February 14, 2012
Last verified: February 2012

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:

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 ]
    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 ]
    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 ]
    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.


Ages Eligible for Study:   18 Years to 26 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Men
  • Treatment naive
  • Hypogonadotrophic hypogonadism

Exclusion Criteria:

  • Previous history of androgen replacement
  • Chronic metabolic disorders
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Please refer to this study by its identifier: NCT01533129

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

Responsible Party: Alper Sonmez, Associate Professor in Medicine, Gulhane School of Medicine Identifier: NCT01533129     History of Changes
Other Study ID Numbers: GSM-022011
Study First Received: December 13, 2011
Last Updated: February 14, 2012

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

Additional relevant MeSH terms:
Insulin Resistance
Pathologic Processes
Glucose Metabolism Disorders
Metabolic Diseases
Gonadal Disorders
Endocrine System Diseases
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents processed this record on April 26, 2017