Association Between Testosterone Levels and COPD Severity | NCT02824809

Studies
Association Between Testosterone Levels and COPD Severity

NCT02824809

Sponsor

Hospital Italiano de Buenos Aires

Status

Unknown status

Last Update Posted

Jul 7, 2016Estimated

Enrollment

150Estimated

Phase

Not provided

Conditions

Chronic Obstructive Pulmonary Disease
Hypogonadism

Interventions

Not provided

Countries

Argentina

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

Jul 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2016

Primary Completion Date

Dec 2016Estimated

Completion Date

Mar 2017Estimated

First Submitted Date

Jul 2, 2016

First Submission Date that Met QC Criteria

Jul 2, 2016

First Posted Date

Jul 7, 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

Jul 2, 2016

Last Update Posted Date

Jul 7, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Horacio Matias Castro, MD, Hospital Italiano de Buenos AiresPrincipal Investigator

Lead Sponsor

Hospital Italiano de Buenos AiresOTHER

Collaborators

Name	Class
Asociacion Argentina Medicina Respiratoria (AAMR)	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

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 Aims of the study are estimate the association between the severity of COPD and free testosterone level and the prevalence of hypogonadism in adult men with stable COPD

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

150Estimated

Measure	Description	Time Frame
Free testosterone Level		One day

Measure	Description	Time Frame
Prevalence of Hypogonadism		One day

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adults Men ≥ 45 years
COPD defined according to clinical diagnosis and spirometry American thoracic society ( ATS) criteria
Stable COPD without recent acute exacerbation (less than 2 weeks)

Exclusion Criteria:

Refusal to participate or informed consent process
Those who are under treatment with testosterone replacement or anti-androgens
Comorbidities: Cirrhosis, Alcoholism, cryptorchidism, panhypopituitarism, Pituitary adenoma.
Orchiectomy
Systemic glucocorticoids (equivalent dose ≥ 4 mg of prednisone in the last 3 weeks).
Relative and absolute contraindications for spirometry.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Outpatients with stable COPD that consult in a tertiary academic teaching hospital in Buenos Aires, Argentina

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Horacio M Castro, MD	Contact	1567622134	054011	matias.castro@hospitalitaliano.org.ar
Joaquin Maritano Furcada, MD	Contact			joaquin.maritano@hospitalitaliano.org.ar

Overall Officials

Name	Affiliation	Role
Horacio M Castro, MD	HIBA, Buenos Aires Argentina	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Italiano de Buenos Aires	Recruiting	Ciudad Autonoma de Buenos Aires	Buenos Aires		Argentina

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive
D007006	Hypogonadism

Ancestor Terms

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease

Browse Leaves

Not provided

Browse Branches

Not provided