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Testosterone Replacement in Male Cancer Survivors With Fatigue and Low Testosterone
NCT04049331 · View on ClinicalTrials.gov ↗
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 Studied
Interventions
- OTHER placebo
- DRUG Testosterone Undecanoate 750 MG/3 ML Intramuscular Solution [AVEED]
Study Locations (2)
Massachusetts
- Brigham and Women's Hospital — Boston
Washington
- Veterans Affairs Puget Sound Health Care System — Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2021-03-22 |
| Est. Completion | 2027-01-30 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04049331
The ClinicalTrials.gov registry entry for NCT04049331 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 240 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Seattle Institute for Biomedical and Clinical Research, which has 17 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Hypogonadism, Male appearing as the primary indexed condition, and to 2 interventions — of which placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04049331 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Massachusetts, Washington. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04049331 about?
NCT04049331 is a clinical study titled "Testosterone Replacement in Male Cancer Survivors With Fatigue and Low Testosterone". 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...
What is the current status of trial NCT04049331?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 240 participants. The study started on 2021-03-22. Estimated completion is 2027-01-30.
What conditions does trial NCT04049331 study?
This clinical trial studies the following conditions: Hypogonadism, Male, Fatigue Syndrome, Chronic. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04049331?
The interventions under investigation include: placebo (OTHER), Testosterone Undecanoate 750 MG/3 ML Intramuscular Solution [AVEED] (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04049331?
This trial is sponsored by Seattle Institute for Biomedical and Clinical Research, which has 17 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04049331 being conducted?
This trial has 2 study locations across Massachusetts, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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