Testosterone Replacement Therapy Decreases Plasma Paraoxo... | NCT01107067

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

NCT01107067

Sponsor

Gulhane School of Medicine

Status

Completed

Last Update Posted

Apr 20, 2010Estimated

Enrollment

32Actual

Phase

Phase 4

Conditions

Hypogonadism

Interventions

Sustanon

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2008

Primary Completion Date

Dec 2009Actual

Completion Date

Dec 2009Actual

First Submitted Date

Apr 19, 2010

First Submission Date that Met QC Criteria

Apr 19, 2010

First Posted Date

Apr 20, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 19, 2010

Last Update Posted Date

Apr 20, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

32Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
testosterone replacement therapy	Experimental		Drug: Sustanon

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sustanon	Drug	250 mg/21 days	testosterone replacement therapy	no name

Measure	Description	Time Frame
paraoxonase level after testosterone treatment

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

25 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aydoğan AYDOĞDU		Ankara		06600	Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D007006	Hypogonadism

Ancestor Terms

ID	Term
D006058	Gonadal Disorders
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013739	Testosterone

Ancestor Terms

ID	Term
D000737	Androstenols
D000736	Androstenes
D000731	Androstanes
D013256	Steroids
D000072473

Browse Leaves

Not provided

Browse Branches

Not provided