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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 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.

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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.

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

FieldValue
Enrollment Target 240 participants
Start Date 2021-03-22
Est. Completion 2027-01-30
Phase Phase 2

What the Registry Record Tells You About NCT04049331

The ClinicalTrials.gov registry entry for NCT04049331 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 240 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 92-participant average among 12 other Hypogonadism, Male trials with a reported enrollment target (161% higher). The listed sponsor is Seattle Institute for Biomedical and Clinical Research, which has 43 total studies on file at ClinicalTrials.gov.

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 2 study locations spanning 2 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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