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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01533129
Recruitment Status : Completed
First Posted : February 15, 2012
Last Update Posted : February 15, 2012
Information provided by (Responsible Party):

Study Description
Brief 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.

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : August 2008
Primary Completion Date : April 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

Eligibility Criteria

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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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
ClinicalTrials.gov Identifier: NCT01533129     History of Changes
Other Study ID Numbers: GSM-022011
First Posted: February 15, 2012    Key Record Dates
Last Update Posted: February 15, 2012
Last Verified: February 2012

Keywords provided by Alper Sonmez, 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