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NCT01107067 Clinical Trial

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

Hypogonadism Clinical Trial

Official title:
Phase IV Study to Investigate the Effect of Testosterone Treatment on Paraoxonase Level in Male Patients With Hypogonadotrophic Hypogonadism

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01107067
Other study ID # aa001
Secondary ID
Status Completed
Phase Phase 4
First received April 19, 2010
Last updated April 19, 2010
Start date June 2008
Est. completion date December 2009

Study information
Verified date May 2008
Source Gulhane School of Medicine
Contact n/a
Is FDA regulated No
Health authority Turkey: Ministry of Health
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 32
Est. completion date December 2009
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender Male
Age group 20 Years to 25 Years
Eligibility 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

Intervention

Drug:
• Sustanon
250 mg/21 days

Locations
Country Name City State
Turkey Aydogan AYDOGDU Ankara

Sponsors (1)
Lead Sponsor Collaborator
Gulhane School of Medicine

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary paraoxonase level after testosterone treatment
See also
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Withdrawn NCT00710827 - Nebido Versus Placebo in Elderly Men With Typical Symptoms of Late Onset Hypogonadism Over a Period of 54 Weeks Phase 4