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Hypogonadism, MaleSexual healthLibidoDrugPhase 2

What this study is

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.

What's being tested

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

    Intervention · DRUG

  • placebo

    Intervention · OTHER

Both interventions

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

Study details

Official title
Improving Patient-Important Outcomes With Testosterone Replacement in Hypogonadal Men With a Prior History of Cancer
Sponsor
Seattle Institute for Biomedical and Clinical Research
Conditions
Hypogonadism, Male · Fatigue Syndrome, Chronic
Enrolling
240 people
Starts
2021-03-22
Est. completion
2027-01-30
Design
Quadruple-blind, randomized, parallel groups, Phase 2
Record
View on ClinicalTrials.gov ↗