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

Phase 4 Study of Effect of Testosteron Replacement Treatment on the Fibroblast Growth Factor-23, Asymmetric Dimethylarginine and Vitamin D Levels in the Congenital Hypogonadotropic Hypogonadism

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02111473
Enrollment
49
Registered
2014-04-11
Start date
2009-05-31
Completion date
2014-04-30
Last updated
2014-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypogonadism

Keywords

endothelial dysfunction, bone mineral metabolism, testosteron replacement treatment

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.

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.

Interventions

DRUGTestosterone

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

Sponsors

Gulhane School of Medicine
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 28 Years
Healthy volunteers
No

Inclusion criteria

* Men * Congenital hypogonadism * Treatment Naive

Exclusion criteria

* Previous history of androgen replacement * Hypertension * Diabetes mellitus

Design outcomes

Primary

MeasureTime frameDescription
the effect of testosteron replacement treatment on the Fibroblast Growth Factor-23.6 monthsPlasma FGF-23 levels were determined by ELISA, (Human Intact FGF-23 ELISA Kit, Inc., San Clement, CA, USA).
the effect of testosteron replacement treatment on the asymmetric dimethylarginine.6 monthsPlasma ADMA levels were determined by ELISA (Immunodiagnostic, Bernheim, Germany)
the effect of testosteron replacement treatment on the vitamin D levels.6 months.Plasma 25-OH vitamin D3 levels were measured by Immuchrom kits (Hessen, Germany) using isocratic HPLC method with UV detector in Prominence HPLC system.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026