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

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ClinicalTrials.gov Identifier: NCT01533129
Recruitment Status : Completed
First Posted : February 15, 2012
Last Update Posted : February 15, 2012
Sponsor:
Information provided by (Responsible Party):
Alper Sonmez, Gulhane School of Medicine

Tracking Information
First Submitted Date  ICMJE December 13, 2011
First Posted Date  ICMJE February 15, 2012
Last Update Posted Date February 15, 2012
Study Start Date  ICMJE August 2008
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 14, 2012)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Testosterone Replacement on Endothelial Dysfunction, Inflammation and Insulin Resistance in Male Hypogonadotrophic Hypogonadism
Official Title  ICMJE 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.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hypogonadotrophic Hypogonadism
Intervention  ICMJE
  • Drug: Testogel 50 mg transdermal gel
    50mg testosterone gel implementation on every night
    Other Name: Testogel 50mg transdermal gel
  • Drug: Testosterone 250mg injection
    The testosterone 250mg ester IM injections performed in three weeks.
    Other Name: Sustanon 250 mg amp.
Study Arms  ICMJE
  • Active Comparator: Daily testosterone transdermal gel
    Intervention: Drug: Testogel 50 mg transdermal gel
  • Active Comparator: Injectable Testosterone esters
    Testosteron 250mg injection per 3-4 weeks for 6 months
    Intervention: Drug: Testosterone 250mg injection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 14, 2012)
106
Original Actual Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Men
  • Treatment naive
  • Hypogonadotrophic hypogonadism

Exclusion Criteria:

  • Previous history of androgen replacement
  • Chronic metabolic disorders
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 26 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01533129
Other Study ID Numbers  ICMJE GSM-022011
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alper Sonmez, Gulhane School of Medicine
Study Sponsor  ICMJE Gulhane School of Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Gulhane School of Medicine
Verification Date February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP