Plasma RBP Levels in Patients With Idiopathic Hypogonadot... | NCT01758094

Studies
Plasma RBP Levels in Patients With Idiopathic Hypogonadotrophic Hypogonadism

NCT01758094

Sponsor

Gulhane School of Medicine

Status

Completed

Last Update Posted

Jan 3, 2013Estimated

Enrollment

25Actual

Phase

Not provided

Conditions

Idiopathic Hypogonadotropic Hypogonadism

Interventions

Sustanon 250 mg ampule (Testosterone esters)

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Aug 2012Actual

Completion Date

Aug 2012Actual

First Submitted Date

Dec 24, 2012

First Submission Date that Met QC Criteria

Dec 24, 2012

First Posted Date

Jan 1, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 1, 2013

Last Update Posted Date

Jan 3, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hypogonadotropic hypogonadism patients		Treatment naive 25 patients with idiopathic hypogonadotrophic hypogonadism	Drug: Sustanon 250 mg ampule (Testosterone esters)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sustanon 250 mg ampule (Testosterone esters)	Drug	Drug used for treatment of hypogonadism	Hypogonadotropic hypogonadism patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Retinol binding protein 4, hs-CRP levels in patients with idiopathic hypogonadotrophic hypogonadism		2008-2012

Secondary Outcomes

Measure	Description	Time Frame
Effect of testosterone treatment on retinol binding globulin 4 and hs-CRP levels in patients with hypogodotrophic hypogonadism		2008-2012

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

26 Years

Standard Ages

Adult

Study Population

Patients with hypogonadotrophic hypogonadism

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Aydogan Aydogdu, MD	Gulhane School of Medicine, Department of Endocrinology and Metabolism	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gulhane School of Medicine Dep. of Endocrinology and Metabolism		Ankara		06018	Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
C562785	Idiopathic Hypogonadotropic Hypogonadism
D007006	Hypogonadism

Ancestor Terms

ID	Term
D006058	Gonadal Disorders
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013739	Testosterone

Ancestor Terms

ID	Term
D000737	Androstenols
D000736	Androstenes
D000731	Androstanes
D013256	Steroids
D000072473

Browse Leaves

Not provided

Browse Branches

Not provided