Association Between Testosterone Levels and COPD Severity

• Conditions: Chronic Obstructive Pulmonary Disease; Hypogonadism

• Registration Number: NCT02824809
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06
• Status Verified: 2016-07
• Study First Submitted: 2016-07-02
• Study First Submitted QC: 2016-07-02
• Last Update Submitted: 2016-07-02
• Study First Posted: 2016-07-07
• Last Update Posted: 2016-07-07
• Primary Completion: 2016-12
• Study Completion: 2017-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 150

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Free testosterone Level	One day

Secondary Outcome Measures

Name	Time	Method
Prevalence of Hypogonadism	One day

Trial Locations

Locations (1)

Hospital Italiano de Buenos Aires; 🇦🇷 Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina