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Trial record 41 of 213 for:    "Hypogonadism" | "Androgens"

Visceral Adiposity Index and Triglyceride/High-density Lipoprotein Cholesterol Ratio in the Congenital Hypogonadotropic Hypogonadism and Effect of Testosteron Treatment

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: NCT02111434
Recruitment Status : Completed
First Posted : April 11, 2014
Last Update Posted : April 14, 2014
Sponsor:
Information provided by (Responsible Party):
cem haymana, Gulhane School of Medicine

Tracking Information
First Submitted Date  ICMJE April 5, 2014
First Posted Date  ICMJE April 11, 2014
Last Update Posted Date April 14, 2014
Study Start Date  ICMJE July 2013
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2014)
  • time to change of visceral adiposity index with testosteron replacement [ Time Frame: baseline and 6 months ]
  • time to change of TG/HDL cholesterol ratio with testosteron replacement [ Time Frame: baseline and 6 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 9, 2014)
  • time to change of visceral adiposity index with testosteron replacement [ Time Frame: 6 months ]
  • time to change of TG/HDL cholesterol ratio with testosteron replacement [ Time Frame: 6 months ]
Change History Complete list of historical versions of study NCT02111434 on ClinicalTrials.gov Archive Site
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 Visceral Adiposity Index and Triglyceride/High-density Lipoprotein Cholesterol Ratio in the Congenital Hypogonadotropic Hypogonadism and Effect of Testosteron Treatment
Official Title  ICMJE Phase 4 Study of Effect of Testosteron Treatment on the Visceral Adiposity Index and Triglyceride/High-density Lipoprotein Cholesterol Ratio in the Congenital Hypogonadotropic Hypogonadism
Brief Summary

The study is designed to answer the following questions:

  1. What is the levels of visceral adiposity index and Triglycerides/HDL cholesterol ratio in hypogonadism?
  2. What is the effect of testosterone replacement on the visceral adiposity index and Triglycerides/HDL cholesterol ratio?
Detailed Description This is a retrospective design, which is performed by investigating the registrations of patients with hypogonadotrophic hypogonadism between the years 2007-2010.
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: Testosterone
Testosterone 250 mg injection per 3-4 weeks for 6 months
Other Name: sustanon 250 mg
Study Arms  ICMJE Experimental: testosterone
testosterone gel per day for 6 months testosterone 250 mg injection per 3-4 weeks for 6 months
Intervention: Drug: Testosterone
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: April 9, 2014)
150
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2014
Actual Primary Completion Date April 2014   (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 NCT02111434
Other Study ID Numbers  ICMJE GSM-022014
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party cem haymana, 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 April 2014

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