drugset / Trial / NCT03674320

Cycled Testosterone Administration During Pulmonary Rehabilitation in Early Stage COPD

NCT03674320

RandomizedParallel-groupQuadruple-blindTreatment

Summary

Chronic obstructive pulmonary disease (COPD) is characterized by chronic inflammation of the airways and/or damage to the lungs which leads to progressive impairment in airflow and the ability to breathe. COPD affects 6 to 20% of the US population and is among the leading causes for mortality in men and women. While COPD is principally a pathology of the airway, skeletal muscle wasting is a widely recognized comorbidity contributing to frequent and expensive hospital visits. Hospital readmission rates among COPD patients are high and the majority of the readmissions are considered preventable. The reasons COPD patients lose muscle are still poorly understood although reduced pulmonary function has been associated with reduced testosterone levels. Muscle building treatments, including testosterone therapy, with and without exercise, have consistently been shown to promote improvements in body composition, exercise capacity, and health related quality of life of COPD patients. The overall goal of this investigation is to provide an effective long-term treatment strategy that prevents the advancement of COPD in men and women through a safe, cycled administration of testosterone during the early stages of disease.

Timeline

Start
2021-12-01
Primary completion
2024-08-01
Completion
2024-12-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Testosterone Enanthate Small molecule 25 mg Intramuscular
Comparator Testosterone Enanthate Small molecule 100 mg Intramuscular