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NCT04049331 · ClinicalTrials.gov registry record · Phase 2
Testosterone Replacement in Male Cancer Survivors With Fatigue and Low Testosterone
A Phase 2 study of Hypogonadism, Male and Fatigue Syndrome, Chronic, sponsored by Seattle Institute for Biomedical and Clinical Research.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 240
- Enrollment target
- 2
- Study locations
NCT04049331: Recruiting Phase 2 study of Hypogonadism, Male and Fatigue Syndrome, Chronic, sponsored by Seattle Institute for Biomedical and Clinical Research.
NCT04049331 is a Phase 2 study of Hypogonadism, Male and Fatigue Syndrome, Chronic that is actively recruiting participants, run by Seattle Institute for Biomedical and Clinical Research. The registered enrollment target is 240 participants, above the 92-participant average among 12 other Hypogonadism, Male trials with a reported enrollment target (161% higher). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04049331, a Phase 2 study of Hypogonadism, Male and Fatigue Syndrome, Chronic, is actively recruiting participants, sponsored by Seattle Institute for Biomedical and Clinical Research.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 240 participants
- Enrollment target
- 2
- Study locations
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.
Primary Outcome
(Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F) questionnaire
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 |
What NCT04049331 shows while recruiting
NCT04049331 is an interventional study that assigns participants to a tested intervention. The registered 240 participants enrollment target is mid-sized for trials with a published cap, above the 92-participant average among 12 other Hypogonadism, Male trials with a reported enrollment target (161% higher).
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.
NCT04049331 reports a single indexed study location in Massachusetts, Washington.
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.
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).
Who is sponsoring clinical trial NCT04049331?
This trial is sponsored by Seattle Institute for Biomedical and Clinical Research, which has 43 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Hypogonadism, Male
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04049331's enrollment target sits among peer trials
240 1st of 12 higher than 12 of 12 other Hypogonadism, Male trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hypogonadism, Male trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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