Association Between Testosterone Levels and COPD Severity (COPDTESTO)

July 2, 2016 updated by: Horacio Matias Castro, Hospital Italiano de Buenos Aires

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

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

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
    • Buenos Aires
      • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Free testosterone Level
Time Frame: One day
One day

Secondary Outcome Measures

Outcome Measure
Time Frame
Prevalence of Hypogonadism
Time Frame: One day
One day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Italiano de Buenos Aires

Collaborators

Asociacion Argentina Medicina Respiratoria (AAMR)

Investigators

  • Principal Investigator: Horacio M Castro, MD, HIBA, Buenos Aires Argentina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

March 1, 2017

Study Registration Dates

First Submitted

July 2, 2016

First Submitted That Met QC Criteria

July 2, 2016

First Posted (Estimate)

July 7, 2016

Study Record Updates

Last Update Posted (Estimate)

July 7, 2016

Last Update Submitted That Met QC Criteria

July 2, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2413

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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