The Effects of Gonadotropin Replacement Therapy in Patien... | NCT02042638

Studies
The Effects of Gonadotropin Replacement Therapy in Patients With Hypogonadism

NCT02042638

Sponsor

Gulhane School of Medicine

Status

Completed

Last Update Posted

Jan 23, 2014Estimated

Enrollment

16Actual

Phase

Not provided

Conditions

Idiopathic Hypogonadotropic Hypogonadism

Interventions

hCG 1500 IU three times a week
Pregnyl (hCG) ampule 1500 IU/three times a week

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

Dec 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 2011

Primary Completion Date

Aug 2013Actual

Completion Date

Aug 2013Actual

First Submitted Date

Dec 28, 2013

First Submission Date that Met QC Criteria

Jan 22, 2014

First Posted Date

Jan 23, 2014Estimated

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 22, 2014

Last Update Posted Date

Jan 23, 2014Estimated

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

6 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
16 treatment naive Hypogonadotropic hypogonadism patients		Treatment naive 16 patients with idiopathic hypogonadotrophic hypogonadism	Drug: hCG 1500 IU three times a week Drug: Pregnyl (hCG) ampule 1500 IU/three times a week

Interventions

Name	Type	Description	Arm Group Labels	Other Names
hCG 1500 IU three times a week	Drug		16 treatment naive Hypogonadotropic hypogonadism patients	Pregnyl (Organon) ampule 1500 IU

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
HDL after hCG treatment	2011-2013	2011-2013
LDL levels after hCG treatment		2011-2013
total cholesterole levels after hCG treatment		2011-2013

Secondary Outcomes

Measure	Description	Time Frame
Body fat ratio after hCG treatment		2011-2013
hsCRP levels after hCG treatment		2011-2013

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: Previous androgen treatment, diabetes mellitus, arterial hypertension other hormone deficiencies

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

45 Years

Standard Ages

ChildAdult

Study Population

Patients with Idiopathic Hypogonadotropic Hypogonadism

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Fahri Bayram, Proffesor	Erciyes University School of Medicine Depatment of Endocrinology and Metabolism Kayseri TURKEY	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

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D006063	Chorionic Gonadotropin

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