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Metabolic Syndrome Criteria and the Effect of Testosterone Treatment in Young Men With 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: NCT01160341
Recruitment Status : Completed
First Posted : July 12, 2010
Last Update Posted : July 12, 2010
Sponsor:
Information provided by:
Gulhane School of Medicine

Tracking Information
First Submitted Date  ICMJE July 9, 2010
First Posted Date  ICMJE July 12, 2010
Last Update Posted Date July 12, 2010
Study Start Date  ICMJE August 2009
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
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 Metabolic Syndrome Criteria and the Effect of Testosterone Treatment in Young Men With Hypogonadism
Official Title  ICMJE Phase 4 Study of About the Effect of Testosterone Treatment on the Components of Metabolic Syndrome
Brief Summary

The study is designed to answer the following questions:

  1. Is hypogonadism a cause for the metabolic syndrome ?
  2. What is the effect of testosterone replacement on the metabolic parameters ?
Detailed Description This is a retrospective design, which is performed by investigating the registrations of patients with hypogonadotrophic hypogonadism between the years 2002-2009.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE Hypogonadism
Intervention  ICMJE Drug: Testosteron
Testosteron 250mg injection per 3-4 weeks for 6 months
Other Name: Sustanon 250mg
Study Arms  ICMJE Experimental: Testosteron, secondary hypogonadism
Intervention: Drug: Testosteron
Publications *

*   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: July¬†9,¬†2010)
312
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2010
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Men
  • Congenital hypogonadism
  • Treatment Naive

Exclusion Criteria:

  • Previous history of androgen replacement
  • Hypertension
  • Diabetes mellitus
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 26 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
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 NCT01160341
Other Study ID Numbers  ICMJE GSM-072010
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Alper Sonmez, Gulhane School of Medicine Department of Endocrinology and Metabolism
Study Sponsor  ICMJE Gulhane School of Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Gulhane School of Medicine
Verification Date January 2010

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