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NCT02824809 Clinical Trial

Association Between Testosterone Levels and COPD Severity

Chronic Obstructive Pulmonary Disease Clinical Trial

— COPDTESTO  

Official title:
Association Between Testosterone Levels and COPD Severity Measured by BODE Index in Men

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02824809
Other study ID # 2413
Secondary ID
Status Recruiting
Phase N/A
First received July 2, 2016
Last updated July 2, 2016
Start date June 2016
Est. completion date March 2017

Study information
Verified date July 2016
Source Hospital Italiano de Buenos Aires
Contact Horacio M Castro, MD
Phone 1567622134
Email matias.castro@hospitalitaliano.org.ar
Is FDA regulated No
Health authority Argentina: Human Research Bioethics Committee
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Recruiting
Enrollment 150
Est. completion date March 2017
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender Male
Age group 45 Years and older
Eligibility 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.

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Locations
Country Name City State
Argentina Hospital Italiano de Buenos Aires Ciudad Autonoma de Buenos Aires Buenos Aires

Sponsors (2)
Lead Sponsor Collaborator
Hospital Italiano de Buenos Aires Asociacion Argentina Medicina Respiratoria (AAMR)

Country where clinical trial is conducted

Argentina, 

Outcome
Type Measure Description Time frame Safety issue
Primary Free testosterone Level One day No
Secondary Prevalence of Hypogonadism One day No
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