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

Hypogonadism Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02111473
• Other study ID #: GSM-032014
• Status: Completed
• Phase: Phase 4
• First received: April 7, 2014
• Last updated: April 9, 2014
• Start date: May 2009
• Est. completion date: April 2014

Study information

• Verified date: April 2014
• Source: Gulhane School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: April 2014
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 28 Years

Eligibility

Inclusion Criteria:

• Men

• Congenital hypogonadism

• Treatment Naive

Exclusion Criteria:

• Previous history of androgen replacement

• Hypertension

• Diabetes mellitus

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypogonadism

Intervention

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

Locations

Country	Name	City	State
Turkey	Gulhane School of Medicine	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Gulhane School of Medicine

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	6 months	No
Primary	the effect of testosteron replacement treatment on the asymmetric dimethylarginine.	Plasma ADMA levels were determined by ELISA (Immunodiagnostic, Bernheim, Germany)	6 months	No
Primary	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.	6 months.	No