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Testosterone Replacement in Male Cancer Survivors With Fatigue and Low Testosterone

NCT04049331 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2026-04-22

No results posted yet for this study

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.

Conditions

  • Hypogonadism, Male
  • Fatigue Syndrome, Chronic

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.

Sponsors & Collaborators

  • Seattle Institute for Biomedical and Clinical Research

    lead OTHER

Principal Investigators

  • Jose M Garcia, MD, PhD · VA Puget Sound Health Care System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
54 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-22
Primary Completion
2027-01-30
Completion
2027-01-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04049331 on ClinicalTrials.gov