NCT02111434

Brief Summary

The study is designed to answer the following questions:

  1. 1.What is the levels of visceral adiposity index and Triglycerides/HDL cholesterol ratio in hypogonadism?
  2. 2.What is the effect of testosterone replacement on the visceral adiposity index and Triglycerides/HDL cholesterol ratio?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2013

Shorter than P25 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

July 1, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

April 5, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 11, 2014

Completed
Last Updated

April 14, 2014

Status Verified

April 1, 2014

Enrollment Period

9 months

First QC Date

April 5, 2014

Last Update Submit

April 10, 2014

Conditions

Hypogonadism

Keywords

visceral adiposity indextriglycerides / hdl cholesterol ratiotestosterone

Outcome Measures

Primary Outcomes (2)

  • time to change of visceral adiposity index with testosteron replacement

    baseline and 6 months

  • time to change of TG/HDL cholesterol ratio with testosteron replacement

    baseline and 6 months

Study Arms (1)

testosterone

EXPERIMENTAL

testosterone gel per day for 6 months 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 - 26 Years
Sexmale
Healthy VolunteersYes
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
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 5, 2014

First Posted

April 11, 2014

Study Start

July 1, 2013

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

April 14, 2014

Record last verified: 2014-04

Locations

TU(1)