Effects of Gonadotropin Replacement Therapy on Metabolic... | NCT02728440

Studies
Effects of Gonadotropin Replacement Therapy on Metabolic Parameters in Patients With Hypogonadism

NCT02728440

Sponsor

Gulhane School of Medicine

Status

Completed

Last Update Posted

Apr 13, 2016Estimated

Enrollment

30Actual

Phase

Not provided

Conditions

Idiopathic Hypogonadotropic Hypogonadism

Interventions

human chorionic gonadotropin, human menopausal gonadotropin

Countries

Not provided

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

Mar 2016

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

May 2010

Primary Completion Date

Dec 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

Mar 27, 2016

First Submission Date that Met QC Criteria

Mar 30, 2016

First Posted Date

Apr 5, 2016Estimated

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

Apr 11, 2016

Last Update Posted Date

Apr 13, 2016Estimated

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

Effects of gonadotrophin replacement therapy Lipid Profile and Oxidative Stress Parameters of Patients with Idiopathic Hypogonadotropic Hypogonadism

Detailed Description

30 male patients diagnosed with IHH and a control group of 20 healthy cases with similar age and BMI were included in the study. The levels of advanced oxidation protein products (AOPP), thiol, malondialdehyde (MDA), nitric oxide (NO) and 8-hydroxydeoxyguanosine (8-OHdG) and the levels of triglyceride (TG), total cholesterol (TC), high density lipoprotein (HDL-K), low density lipoprotein (LDL-K), Apolipoprotein A1 (ApoA1) and Apolipoprotein B100 (ApoB100) were measured before and after gonadotrophin therapy.

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

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hypogonadotropic hypogonadism patients		30 patients with idiopathic hypogonadotrophic hypogonadism	Drug: human chorionic gonadotropin, human menopausal gonadotropin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
human chorionic gonadotropin, human menopausal gonadotropin	Drug	drug for the treatment of male hypogonadism	Hypogonadotropic hypogonadism patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
oxidative stress after hCG and HMG treatment		2010-2012
HDL levels after hCG treatment		2010-2012
total cholesterole levels after hCG treatment		2010-2012

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Serum testosterone concentration < 300ng/dL Absence of a pituitary or hypothalamic mass lesions, Presence of gonadotropin response to GnRH, -

Exclusion Criteria:

diabetes mellitus, arterial hypertension other hormone deficiencies

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

22 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Patients with Idiopathic Hypogonadotropic Hypogonadism and healthy control group

Sampling Method

Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
C562785	Idiopathic Hypogonadotropic Hypogonadism

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D006063	Chorionic Gonadotropin
D008596	Menotropins

Ancestor Terms

ID	Term
D006062	Gonadotropins
D036361	Peptide Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists

Browse Leaves

Not provided

Browse Branches

Not provided