NCT01107067

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 19, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 20, 2010

Completed
Last Updated

April 20, 2010

Status Verified

May 1, 2008

Enrollment Period

1.5 years

First QC Date

April 19, 2010

Last Update Submit

April 19, 2010

Conditions

Hypogonadism

Keywords

hypogonadismparaoxonaseHipogonadism

Outcome Measures

Primary Outcomes (1)

  • paraoxonase level after testosterone treatment

Study Arms (1)

testosterone replacement therapy

EXPERIMENTAL
Drug: Sustanon

Interventions

SustanonDRUG

250 mg/21 days

Also known as: no name
testosterone replacement therapy

Eligibility Criteria

Age20 Years - 25 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Volunteers patients with hypogonadism

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aydoğan AYDOĞDU

Ankara, 06600, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hypogonadism

Interventions

Testosterone

Condition Hierarchy (Ancestors)

Gonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

AndrostenolsAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsTestosterone CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 19, 2010

First Posted

April 20, 2010

Study Start

June 1, 2008

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

April 20, 2010

Record last verified: 2008-05

Locations

TU(1)