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CompletedNCT02111473Updated Apr 11, 2014

The Effect of Testosteron Replacement Treatment on the Fibroblast Growth Factor-23, Asymmetric Dimethylarginine and Vitamin D Levels in the Congenital Hypogonadotropic Hypogonadism

A Phase 4 interventional study of Testosterone in Hypogonadism, sponsored by Gulhane School of Medicine. Completed at 1 site in Turkey. Open to male participants aged 18 Years to 28 Years. Per ClinicalTrials.gov, last updated 2014-04-11.

Sponsored by Gulhane School of Medicine · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
49
Allocation
Not applicable
Ages
18 Years to 28 Years
Sex
Male
01

Study 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.

Read the detailed description

this is an interventional study which is examine the effect of testosteron replacement treatment on the endothelial dysfunction and bone mineral metabolism in hypogonadotropic hypogonadal patients.

02

Conditions studied

  • Hypogonadism

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Keywords

  • endothelial dysfunction
  • bone mineral metabolism
  • testosteron replacement treatment
03

In context

Hypogonadism

345 studies on the registry are indexed under Hypogonadism; 43 are open to participants now.

This study's enrollment of 49 is below the median of 56 across 260 interventional studies indexed under Hypogonadism.

Browse Hypogonadism studies →

Lead sponsor

Gulhane School of Medicine is the lead sponsor of 66 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 28 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  • Men
  • Congenital hypogonadism
  • Treatment Naive

Exclusion criteria

Exclusion Criteria:

  • Previous history of androgen replacement
  • Hypertension
  • Diabetes mellitus
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
49 participants (actual)

Study arms

  • Other
    testosterone

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

    Drug: Testosterone

Interventions

  • DrugTestosterone

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

    Also known as: sustanon 250 mg

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 6 months

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

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

    Time frame: 6 months

  3. 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.

    Time frame: 6 months.

07

Study locations

1 site
  • Gulhane School of Medicine
    Ankara, 06018, Turkey
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 11, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02111473
Lead sponsor
Gulhane School of Medicine
Responsible party
cem haymana (MD, Gulhane School of Medicine) — Principal investigator
First posted
Apr 11, 2014
Start date
May 2009
Primary completion
May 2012
Completion
Apr 2014
Last update
Apr 11, 2014

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.

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