NCT01533129

Brief Summary

The study searched for answers to two questions

  1. 1.What is the effect of testosterone replacement therapy on endothelial dysfunction, inflammation and insulin resistance?
  2. 2.Regarding the above parameters, is there any difference between daily transdermal testosterone implementation and intramuscular injection performed in three weeks.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
106

participants targeted

Target at P50-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

August 1, 2008

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 13, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 15, 2012

Completed
Last Updated

July 22, 2020

Status Verified

July 1, 2020

Enrollment Period

2.7 years

First QC Date

December 13, 2011

Last Update Submit

July 21, 2020

Conditions

Hypogonadotrophic Hypogonadism

Keywords

HypogonadismEndothelial dysfunctionInflammationInsulin resistanceTestosterone replacement therapy

Outcome Measures

Primary Outcomes (3)

  • The alterations in the measures for endothelial functions

    The alterations in Endothelial functions are determined by measuring plazma ADMA levels, as a surrogate. ADMA measurement is pereformed by ELISA kit (Immundiagnotik, Bensheim, Germany)(Catalog Number 7828) with a minimal detection limit of 0.05µmol/L.

    6 months

  • The alterations in the measures of insulin resistance

    The alterations in insulin sensitivity are estimated by using the HOMA index by the formula, HOMA-IR = (insulin x glucose)/405.

    6 months

  • The alterations in the measures of inflammation

    The alterations in the measures of inflammation are determined by measuring Human Pentraxin-3 levels. ELISA kiti /R\&D Systems, Inc. Minneapolis, MN, ABD) (Catalog number DPTX30) with a minimal detection limit of 0.025ng/ml, intraassay CV of 3.8-4.4%, and interassay CV of 4.1-6.1% was used.

    6 months

Study Arms (2)

Daily testosterone transdermal gel

ACTIVE COMPARATOR
Drug: Testogel 50 mg transdermal gel

Injectable Testosterone esters

ACTIVE COMPARATOR

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

Drug: Testosterone 250mg injection

Interventions

Testogel 50 mg transdermal gelDRUG

50mg testosterone gel implementation on every night

Also known as: Testogel 50mg transdermal gel
Daily testosterone transdermal gel
Testosterone 250mg injectionDRUG

The testosterone 250mg ester IM injections performed in three weeks.

Also known as: Sustanon 250 mg amp.
Injectable Testosterone esters

Eligibility Criteria

Age18 Years - 26 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Men
  • Treatment naive
  • Hypogonadotrophic hypogonadism

You may not qualify if:

  • Previous history of androgen replacement
  • Chronic metabolic disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gulhane School of Medicine Department of Endocrinology and Metabolism

Ankara, Non US, 06018, Turkey (Türkiye)

Location

MeSH Terms

Conditions

HypogonadismInflammationInsulin Resistance

Interventions

TestosteroneInjectionsAdenosine Monophosphate

Condition Hierarchy (Ancestors)

Gonadal DisordersEndocrine System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

AndrostenolsAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsTestosterone CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsDrug Administration RoutesDrug TherapyTherapeuticsAdenine NucleotidesPurine NucleotidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleotidesNucleic Acids, Nucleotides, and NucleosidesRibonucleotides

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor in Medicine

Study Record Dates

First Submitted

December 13, 2011

First Posted

February 15, 2012

Study Start

August 1, 2008

Primary Completion

April 1, 2011

Last Updated

July 22, 2020

Record last verified: 2020-07

Locations

TU(1)