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Metabolic Syndrome Criteria and the Effect of Testosterone Treatment in Young Men With Hypogonadism

Primary Purpose

Hypogonadism

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Testosteron
Sponsored by
Gulhane School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Hypogonadism focused on measuring Metabolic syndrome, Hypogonadism, Testosterone

Eligibility Criteria

18 Years - 26 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Men
  • Congenital hypogonadism
  • Treatment Naive

Exclusion Criteria:

  • Previous history of androgen replacement
  • Hypertension
  • Diabetes mellitus

Sites / Locations

  • Gulhane School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Testosteron, secondary hypogonadism

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 9, 2010
Last Updated
July 9, 2010
Sponsor
Gulhane School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01160341
Brief Title
Metabolic Syndrome Criteria and the Effect of Testosterone Treatment in Young Men With Hypogonadism
Official Title
Phase 4 Study of About the Effect of Testosterone Treatment on the Components of Metabolic Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Gulhane School of Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The study is designed to answer the following questions: Is hypogonadism a cause for the metabolic syndrome ? 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypogonadism
Keywords
Metabolic syndrome, Hypogonadism, Testosterone

7. Study Design

Primary Purpose
Screening
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
312 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Testosteron, secondary hypogonadism
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Testosteron
Other Intervention Name(s)
Sustanon 250mg
Intervention Description
Testosteron 250mg injection per 3-4 weeks for 6 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
26 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Men Congenital hypogonadism Treatment Naive Exclusion Criteria: Previous history of androgen replacement Hypertension Diabetes mellitus
Facility Information:
Facility Name
Gulhane School of Medicine
City
Ankara
ZIP/Postal Code
06018
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
16846397
Citation
Mulligan T, Frick MF, Zuraw QC, Stemhagen A, McWhirter C. Prevalence of hypogonadism in males aged at least 45 years: the HIM study. Int J Clin Pract. 2006 Jul;60(7):762-9. doi: 10.1111/j.1742-1241.2006.00992.x.
Results Reference
background
PubMed Identifier
15579737
Citation
Araujo AB, O'Donnell AB, Brambilla DJ, Simpson WB, Longcope C, Matsumoto AM, McKinlay JB. Prevalence and incidence of androgen deficiency in middle-aged and older men: estimates from the Massachusetts Male Aging Study. J Clin Endocrinol Metab. 2004 Dec;89(12):5920-6. doi: 10.1210/jc.2003-031719.
Results Reference
background
PubMed Identifier
17916569
Citation
Saad F, Gooren LJ, Haider A, Yassin A. A dose-response study of testosterone on sexual dysfunction and features of the metabolic syndrome using testosterone gel and parenteral testosterone undecanoate. J Androl. 2008 Jan-Feb;29(1):102-5. doi: 10.2164/jandrol.107.002774. Epub 2007 Oct 3.
Results Reference
background
PubMed Identifier
1672855
Citation
Koesling D, Schultz G, Bohme E. Sequence homologies between guanylyl cyclases and structural analogies to other signal-transducing proteins. FEBS Lett. 1991 Mar 25;280(2):301-6. doi: 10.1016/0014-5793(91)80317-v.
Results Reference
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Metabolic Syndrome Criteria and the Effect of Testosterone Treatment in Young Men With Hypogonadism

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