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Association Between Testosterone Levels and COPD Severity (COPDTESTO)

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ClinicalTrials.gov Identifier: NCT02824809
Recruitment Status : Unknown
Verified July 2016 by Horacio Matias Castro, Hospital Italiano de Buenos Aires.
Recruitment status was:  Recruiting
First Posted : July 7, 2016
Last Update Posted : July 7, 2016
Sponsor:
Collaborator:
Asociacion Argentina Medicina Respiratoria (AAMR)
Information provided by (Responsible Party):
Horacio Matias Castro, Hospital Italiano de Buenos Aires

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

Condition or disease
Chronic Obstructive Pulmonary Disease Hypogonadism

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Association Between Testosterone Levels and COPD Severity Measured by BODE Index in Men
Study Start Date : June 2016
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : March 2017

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Free testosterone Level [ Time Frame: One day ]

Secondary Outcome Measures :
  1. Prevalence of Hypogonadism [ Time Frame: One day ]


Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Outpatients with stable COPD that consult in a tertiary academic teaching hospital in Buenos Aires, Argentina
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02824809


Contacts
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Contact: Horacio M Castro, MD 1567622134 ext 054011 matias.castro@hospitalitaliano.org.ar
Contact: Joaquin Maritano Furcada, MD joaquin.maritano@hospitalitaliano.org.ar

Locations
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Argentina
Hospital Italiano de Buenos Aires Recruiting
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Contact: Horacio M Castro, MD    54-11-67622134    matias.castro@hospitalitaliano.org.ar   
Sponsors and Collaborators
Hospital Italiano de Buenos Aires
Asociacion Argentina Medicina Respiratoria (AAMR)
Investigators
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Principal Investigator: Horacio M Castro, MD HIBA, Buenos Aires Argentina
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Responsible Party: Horacio Matias Castro, MD, Hospital Italiano de Buenos Aires
ClinicalTrials.gov Identifier: NCT02824809    
Other Study ID Numbers: 2413
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: July 7, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Horacio Matias Castro, Hospital Italiano de Buenos Aires:
hypogonadism
Chronic Obstructive Pulmonary Disease
Severity of Illness Index
Testosterone
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Hypogonadism
Respiratory Tract Diseases
Gonadal Disorders
Endocrine System Diseases