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Completed

NCT Number: NCT02111473

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

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.

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Key information

Conditions

Hypogonadism Endocrine System Diseases Gonadal Disorders

Age range

18 year–28 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Gulhane School of Medicine

Ankara, 06018, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men
  • Congenital hypogonadism
  • Treatment Naive

Exclusion criteria

  • Previous history of androgen replacement
  • Hypertension
  • Diabetes mellitus

Treatment and study plan

Testosterone

Drug

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

Other names: sustanon 250 mg

Primary outcomes

  1. the effect of testosteron replacement treatment on the Fibroblast Growth Factor-23.

    Time frame: 6 months

    Plasma FGF-23 levels were determined by ELISA, (Human Intact FGF-23 ELISA Kit, Inc., San Clement, CA, USA).

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

    Time frame: 6 months

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

  3. the effect of testosteron replacement treatment on the vitamin D levels.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Gulhane School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2014
First posted
Apr 11, 2014
Registry last updated
Apr 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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