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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

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ClinicalTrials.gov Identifier: NCT02111473
Recruitment Status : Completed
First Posted : April 11, 2014
Last Update Posted : April 11, 2014
Sponsor:
Information provided by (Responsible Party):
cem haymana, Gulhane School of Medicine

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.


Condition or disease Intervention/treatment Phase
Hypogonadism Drug: Testosterone Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : May 2009
Actual Primary Completion Date : May 2012
Actual Study Completion Date : April 2014


Arm Intervention/treatment
testosterone
testosterone 250 mg injection per 3-4 weeks for 6 months
Drug: Testosterone
Testosterone 250 mg injection per 3-4 weeks for 6 months
Other Name: sustanon 250 mg




Primary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 28 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men
  • Congenital hypogonadism
  • Treatment Naive

Exclusion Criteria:

  • Previous history of androgen replacement
  • Hypertension
  • Diabetes mellitus

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02111473


Locations
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Turkey
Gulhane School of Medicine
Ankara, Turkey, 06018
Sponsors and Collaborators
Gulhane School of Medicine

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Responsible Party: cem haymana, MD, Gulhane School of Medicine
ClinicalTrials.gov Identifier: NCT02111473     History of Changes
Other Study ID Numbers: GSM-032014
First Posted: April 11, 2014    Key Record Dates
Last Update Posted: April 11, 2014
Last Verified: April 2014
Keywords provided by cem haymana, Gulhane School of Medicine:
endothelial dysfunction
bone mineral metabolism
testosteron replacement treatment
Additional relevant MeSH terms:
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Hypogonadism
Gonadal Disorders
Endocrine System Diseases
Vitamin D
Methyltestosterone
Testosterone
Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate
N,N-dimethylarginine
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors