Association Between Testosterone Levels and COPD Severity

NCT ID: NCT02824809

Last Updated: 2016-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-30

Study Completion Date

2017-03-31

Brief Summary

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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

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Conditions

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Chronic Obstructive Pulmonary Disease Hypogonadism

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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.
Minimum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Asociacion Argentina Medicina Respiratoria (AAMR)

UNKNOWN

Sponsor Role collaborator

Hospital Italiano de Buenos Aires

OTHER

Sponsor Role lead

Responsible Party

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Horacio Matias Castro

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Horacio M Castro, MD

Role: PRINCIPAL_INVESTIGATOR

HIBA, Buenos Aires Argentina

Locations

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Hospital Italiano de Buenos Aires

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Site Status RECRUITING

Countries

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Argentina

Central Contacts

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Horacio M Castro, MD

Role: CONTACT

1567622134 ext. 054011

Joaquin Maritano Furcada, MD

Role: CONTACT

Facility Contacts

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Horacio M Castro, MD

Role: primary

54-11-67622134

Other Identifiers

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2413

Identifier Type: -

Identifier Source: org_study_id

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