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Testosterone Replacement Therapy Decreases Plasma Paraoxonase 1 Enzyme Activity In Male Patients With Hypogonadism

Primary Purpose

Hypogonadism

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Sustanon
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 hypogonadism, paraoxonase, Hipogonadism

Eligibility Criteria

20 Years - 25 Years (Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Volunteers patients with hypogonadism

Exclusion Criteria:

  • Coronary heart disease
  • Other pituitary/hypothalamic disorders or other non-hypogonadism diseases
  • None was receiving vitamins, lipid-lowering drugs, or other medications known to interfere with PON1 activity, lipid profile, or gonadal function

Sites / Locations

  • Aydoğan AYDOĞDU

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

testosterone replacement therapy

Arm Description

Outcomes

Primary Outcome Measures

paraoxonase level after testosterone treatment

Secondary Outcome Measures

Full Information

First Posted
April 19, 2010
Last Updated
April 19, 2010
Sponsor
Gulhane School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01107067
Brief Title
Testosterone Replacement Therapy Decreases Plasma Paraoxonase 1 Enzyme Activity In Male Patients With Hypogonadism
Official Title
Phase IV Study to Investigate the Effect of Testosterone Treatment on Paraoxonase Level in Male Patients With Hypogonadotrophic Hypogonadism
Study Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Gulhane School of Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is investigating the effect of testosterone treatment on paraoxonase level in male patients with hypogonadotrophic hypogonadism

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypogonadism
Keywords
hypogonadism, paraoxonase, Hipogonadism

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
testosterone replacement therapy
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Sustanon
Other Intervention Name(s)
no name
Intervention Description
250 mg/21 days
Primary Outcome Measure Information:
Title
paraoxonase level after testosterone treatment

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Volunteers patients with hypogonadism Exclusion Criteria: Coronary heart disease Other pituitary/hypothalamic disorders or other non-hypogonadism diseases None was receiving vitamins, lipid-lowering drugs, or other medications known to interfere with PON1 activity, lipid profile, or gonadal function
Facility Information:
Facility Name
Aydoğan AYDOĞDU
City
Ankara
ZIP/Postal Code
06600
Country
Turkey

12. IPD Sharing Statement

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Testosterone Replacement Therapy Decreases Plasma Paraoxonase 1 Enzyme Activity In Male Patients With Hypogonadism

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