NCT02171390

Brief Summary

The study searched for answers to two questions

  1. 1.Is there endothelial dysfunction, inflammation and insulin resistance in patients with congenital hypogonadotropic hypogonadism?
  2. 2.What is the effect of testosterone replacement therapy on endothelial dysfunction, inflammation and insulin resistance?

Trial Health

80
On Track

Trial Health Score

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

Enrollment
130

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
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

June 20, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 24, 2014

Completed
Last Updated

June 24, 2014

Status Verified

March 1, 2014

Enrollment Period

3.8 years

First QC Date

June 20, 2014

Last Update Submit

June 20, 2014

Conditions

Hypogonadotrophic Hypogonadism

Keywords

HypogonadismEndothelial dysfunctionInsulin resistanceInflammationTestosterone replacement therapy

Outcome Measures

Primary Outcomes (3)

  • The alterations in the measures for endothelial functions

    The alterations in Endothelial functions are determined by measuring plasma asymmetric dimethylarginine (ADMA) levels, as a surrogate. ADMA measurement is performed by ELISA kit (Immunodiagnostic, Bernheim, Germany)(Catalog Number 7828) with a minimal detection limit of 0.05µmol/L.

    6 months

  • The alterations in the measures of inflammation

    The alterations in the measures of inflammation are determined by measuring plasma TWEAK levels. ELISA kit (Bender MedSystems, Lot Nr.BMS2006INST, Vienna, Austria) was used.

    6 months

  • The alterations in the measures of insulin resistance

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

    6 months.

Study Arms (2)

Daily testosterone transdermal gel

ACTIVE COMPARATOR
Drug: Testosteron 50 mg transdermal gel

Injectable Testosterone esters

ACTIVE COMPARATOR

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

Drug: Testosterone 250mg injection

Interventions

Testosterone 250mg injectionDRUG

The testosterone 250mg ester intramuscular injections performed in three weeks

Also known as: Sustanon 250 mg amp.
Injectable Testosterone esters
Testosteron 50 mg transdermal gelDRUG

50mg testosterone gel implemented on every night

Also known as: Testogel 50mg transdermal gel
Daily testosterone transdermal gel

Eligibility Criteria

Age18 Years - 26 Years
Sexmale
Healthy VolunteersYes
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, NonUS, 06018, Turkey (Türkiye)

Location

MeSH Terms

Conditions

HypogonadismInsulin ResistanceInflammation

Interventions

TestosteroneInjectionsAdenosine MonophosphateTestosterone Propionate

Condition Hierarchy (Ancestors)

Gonadal DisordersEndocrine System DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

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

June 20, 2014

First Posted

June 24, 2014

Study Start

August 1, 2008

Primary Completion

June 1, 2012

Last Updated

June 24, 2014

Record last verified: 2014-03

Locations

TU(1)