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RecruitingPhase 2NCT04049331

Testosterone Replacement in Male Cancer Survivors With Fatigue and Low Testosterone

Improving Patient-Important Outcomes With Testosterone Replacement in Hypogonadal Men With a Prior History of Cancer

Sponsor

Seattle Institute for Biomedical and Clinical Research

Enrollment

240 participants

Start Date

Mar 22, 2021

Study Type

INTERVENTIONAL

Conditions

Hypogonadism, MaleFatigue Syndrome, Chronic

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.

Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 54 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Testosterone Undecanoate 750 MG/3 ML Intramuscular Solution [AVEED] and placebo for people with fatigue syndrome, chronic and hypogonadism, male. The study is currently recruiting participants at 2 locations. People eligible for this study include men aged 18 Years to 54 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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

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

OTHERplacebo

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

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NCT04049331

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