NCT02111473

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
49

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2009

Longer than P75 for phase_4

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

May 1, 2009

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

April 7, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 11, 2014

Completed
Last Updated

April 11, 2014

Status Verified

April 1, 2014

Enrollment Period

3 years

First QC Date

April 7, 2014

Last Update Submit

April 9, 2014

Conditions

Hypogonadism

Keywords

endothelial dysfunctionbone mineral metabolismtestosteron replacement treatment

Outcome Measures

Primary Outcomes (3)

  • 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).

    6 months

  • the effect of testosteron replacement treatment on the asymmetric dimethylarginine.

    Plasma ADMA levels were determined by ELISA (Immunodiagnostic, Bernheim, Germany)

    6 months

  • 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.

    6 months.

Study Arms (1)

testosterone

OTHER

testosterone 250 mg injection per 3-4 weeks for 6 months

Drug: Testosterone

Interventions

TestosteroneDRUG

Testosterone 250 mg injection per 3-4 weeks for 6 months

Also known as: sustanon 250 mg
testosterone

Eligibility Criteria

Age18 Years - 28 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Men
  • Congenital hypogonadism
  • Treatment Naive

You may not qualify if:

  • Previous history of androgen replacement
  • Hypertension
  • Diabetes mellitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gulhane School of Medicine

Ankara, 06018, 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
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 7, 2014

First Posted

April 11, 2014

Study Start

May 1, 2009

Primary Completion

May 1, 2012

Study Completion

April 1, 2014

Last Updated

April 11, 2014

Record last verified: 2014-04

Locations

TU(1)