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Plasma RBP Levels in Patients With Idiopathic Hypogonadotrophic Hypogonadism

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Aydogan Aydogdu, Gulhane School of Medicine
ClinicalTrials.gov Identifier:
NCT01758094
First received: December 24, 2012
Last updated: January 1, 2013
Last verified: January 2013
History of Changes
  Purpose

The aim of the present study was to demonstrate the RBP4 levels, association of RBP4 with insulin resistance and influence of testosterone treatment on this cytokine in patients with idiopathic hypogonadotropic hypogonadism.


Condition Intervention
Idiopathic Hypogonadotropic Hypogonadism
 Drug: Sustanon 250 mg ampule (Testosterone esters)

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective

Resource links provided by NLM:

MedlinePlus related topics: Vitamin A
U.S. FDA Resources

Further study details as provided by Gulhane School of Medicine:

Primary Outcome Measures:
  • Retinol binding protein 4, hs-CRP levels in patients with idiopathic hypogonadotrophic hypogonadism [ Time Frame: 2008-2012 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Effect of testosterone treatment on retinol binding globulin 4 and hs-CRP levels in patients with hypogodotrophic hypogonadism [ Time Frame: 2008-2012 ] [ Designated as safety issue: Yes ]

Enrollment: 25
Study Start Date: January 2008
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Hypogonadotropic hypogonadism patients
Treatment naive 25 patients with idiopathic hypogonadotrophic hypogonadism
 Drug: Sustanon 250 mg ampule (Testosterone esters)
Drug used for treatment of hypogonadism
Other Name: No name

  Eligibility

Ages Eligible for Study:   19 Years to 26 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Patients with hypogonadotrophic hypogonadism

Criteria

Inclusion Criteria:

decreased serum testosterone concentration below the normal range (serum T < 300ng/dL), FSH and LH levels within or below the normal range, absence of a pituitary or hypothalamic mass lesions on MRI, presence of gonadotropin response to repetitive doses of GnRH, normal smell test and normal karyotypes

Exclusion Criteria:

previous androgen treatment, history of smoking, presence of bilateral anorchia, intellectual deficiency, diabetes mellitus, arterial hypertension or dyslipoproteinemia, medication of any kind and drug abuse. Because of possible confounding effects, patients with other hormone deficiencies were excluded.

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  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01758094

Locations
Turkey
Gulhane School of Medicine Dep. of Endocrinology and Metabolism
Ankara, Turkey, 06018
Sponsors and Collaborators
Gulhane School of Medicine
Investigators
Study Director: Aydogan Aydogdu, MD Gulhane School of Medicine, Department of Endocrinology and Metabolism
  More Information

No publications provided

Responsible Party: Aydogan Aydogdu, MD, Gulhane School of Medicine
ClinicalTrials.gov Identifier: NCT01758094     History of Changes
Other Study ID Numbers: 24122012
Study First Received: December 24, 2012
Last Updated: January 1, 2013
Health Authority: Turkey: Ethics Committee

Keywords provided by Gulhane School of Medicine:
hypogonadism
Retinol binding globulin 4
Testosterone treatment

Additional relevant MeSH terms:
Hypogonadism
Gonadal Disorders
Endocrine System Diseases
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on May 21, 2013