Back to resultsThe Effect of Testosteron Replacement Treatment on the Fibroblast Growth Factor-23, Asymmetric Dimethylarginine and Vitamin D Levels in the Congenital Hypogonadotropic Hypogonadism
Primary Purpose
Hypogonadism
Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Testosterone
Sponsored by
About this trial
This is an interventional treatment trial for Hypogonadism focused on measuring endothelial dysfunction, bone mineral metabolism, testosteron replacement treatment
Eligibility Criteria
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
Other
Arm Label
testosterone
Arm Description
testosterone 250 mg injection per 3-4 weeks for 6 months
Outcomes
Primary Outcome Measures
the effect of testosteron replacement treatment on the Fibroblast Growth Factor-23.
Plasma FGF-23 levels were determined by ELISA, (Human Intact FGF-23 ELISA Kit, Inc., San Clement, CA, USA).
the effect of testosteron replacement treatment on the asymmetric dimethylarginine.
Plasma ADMA levels were determined by ELISA (Immunodiagnostic, Bernheim, Germany)
the effect of testosteron replacement treatment on the vitamin D levels.
Plasma 25-OH vitamin D3 levels were measured by Immuchrom kits (Hessen, Germany) using isocratic HPLC method with UV detector in Prominence HPLC system.
Secondary Outcome Measures
Full Information
NCT ID
NCT02111473
First Posted
April 7, 2014
Last Updated
April 9, 2014
Sponsor
Gulhane School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02111473
Brief Title
The Effect of Testosteron Replacement Treatment on the Fibroblast Growth Factor-23, Asymmetric Dimethylarginine and Vitamin D Levels in the Congenital Hypogonadotropic Hypogonadism
Official Title
Phase 4 Study of Effect of Testosteron Replacement Treatment on the Fibroblast Growth Factor-23, Asymmetric Dimethylarginine and Vitamin D Levels in the Congenital Hypogonadotropic Hypogonadism
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
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:
1) What is the effect of testosteron replacement treatment on the endothelial dysfunction.
2/ What is the effect of testosteron replacement on the bone mineral metabolism.
Detailed Description
this is an interventional study which is examine the effect of testosteron replacement treatment on the endothelial dysfunction and bone mineral metabolism in hypogonadotropic hypogonadal patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypogonadism
Keywords
endothelial dysfunction, bone mineral metabolism, testosteron replacement treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
testosterone
Arm Type
Other
Arm Description
testosterone 250 mg injection per 3-4 weeks for 6 months
Intervention Type
Drug
Intervention Name(s)
Testosterone
Other Intervention Name(s)
sustanon 250 mg
Intervention Description
Testosterone 250 mg injection per 3-4 weeks for 6 months
Primary Outcome Measure Information:
Title
the effect of testosteron replacement treatment on the Fibroblast Growth Factor-23.
Description
Plasma FGF-23 levels were determined by ELISA, (Human Intact FGF-23 ELISA Kit, Inc., San Clement, CA, USA).
Time Frame
6 months
Title
the effect of testosteron replacement treatment on the asymmetric dimethylarginine.
Description
Plasma ADMA levels were determined by ELISA (Immunodiagnostic, Bernheim, Germany)
Time Frame
6 months
Title
the effect of testosteron replacement treatment on the vitamin D levels.
Description
Plasma 25-OH vitamin D3 levels were measured by Immuchrom kits (Hessen, Germany) using isocratic HPLC method with UV detector in Prominence HPLC system.
Time Frame
6 months.
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
28 Years
Accepts Healthy Volunteers
No
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
Learn more about this trial
The Effect of Testosteron Replacement Treatment on the Fibroblast Growth Factor-23, Asymmetric Dimethylarginine and Vitamin D Levels in the Congenital Hypogonadotropic Hypogonadism
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