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Testosterone Replacement in Male Cancer Survivors With Fatigue and Low Testosterone
Sponsor: Seattle Institute for Biomedical and Clinical Research
Summary
The overall goal of this study is to evaluate the effect of a testosterone drug called Depo-Testosterone (or 'testosterone cypionate'), an FDA-approved drug for improving fatigue, sexual function, quality of life, body composition, muscle strength, and physical activity in young cancer survivors who report fatigue and have low testosterone. Main hypothesis is that Testosterone administration in young male cancer survivors who are in remission for at least 1 year, report cancer-related fatigue and have symptomatic testosterone deficiency will be associated with greater improvements in fatigue scores compared with placebo.
Official title: Improving Patient-Important Outcomes With Testosterone Replacement in Hypogonadal Men With a Prior History of Cancer
Key Details
Gender
MALE
Age Range
18 Years - 54 Years
Study Type
INTERVENTIONAL
Enrollment
240
Start Date
2021-03-22
Completion Date
2027-01-30
Last Updated
2025-03-11
Healthy Volunteers
No
Interventions
Testosterone Undecanoate 750 MG/3 ML Intramuscular Solution [AVEED]
first two doses four weeks apart; following three more doses every ten weeks.
placebo
first two doses four weeks apart; following three more doses every ten weeks.
Locations (2)
Brigham and Women's Hospital
Boston, Massachusetts, United States
Veterans Affairs Puget Sound Health Care System
Seattle, Washington, United States