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

Tracking Information
First Received Date ^ICMJE	December 13, 2011
Last Updated Date	February 14, 2012
Start Date ^ICMJE	August 2008
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 ] [ 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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01533129 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	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 What is the effect of testosterone replacement therapy on endothelial dysfunction, inflammation and insulin resistance? 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	Phase 4
Study Design ^ICMJE	Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: 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 Arm (s)	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
Enrollment ^ICMJE	106
Completion Date	Not Provided
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
Gender	Male
Ages	18 Years to 26 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Turkey

Administrative Information
NCT Number ^ICMJE	NCT01533129
Other Study ID Numbers ^ICMJE	GSM-022011
Has Data Monitoring Committee	No
Responsible Party	Alper Sonmez, Gulhane School of Medicine
Study Sponsor ^ICMJE	Gulhane School of Medicine
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	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

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