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RECRUITING
NCT04049331
PHASE2

Testosterone Replacement in Male Cancer Survivors With Fatigue and Low Testosterone

Sponsor: Seattle Institute for Biomedical and Clinical Research

View on ClinicalTrials.gov

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

DRUG

Testosterone Undecanoate 750 MG/3 ML Intramuscular Solution [AVEED]

first two doses four weeks apart; following three more doses every ten weeks.

OTHER

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