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RECRUITING Phase 2

Improving Cancer-related Fatigue, Sexual Dysfunction and Quality of Life in Older Men With Cancer and Androgen Deficiency

NCT04301765 · View on ClinicalTrials.gov ↗

Study Summary

This is a large randomized, double-blind, placebo-controlled trial to determine the efficacy of testosterone replacement on cancer-related fatigue in older men with solid or hematologic (blood) cancer who report fatigue and have low testosterone levels.

Interventions

  • DRUG testosterone 1.62% gel
  • OTHER placebo gel

Study Locations (3)

Georgia

  • Georgia Cancer Center at Augusta University — Augusta

Massachusetts

  • Brigham and Women's Hospital — Boston

Washington

  • Veterans Affairs Puget Sound Health Care System — Seattle

Trial Details

FieldValue
Enrollment Target 230 participants
Start Date 2021-01-12
Est. Completion 2026-01-31
Phase Phase 2

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04301765

The ClinicalTrials.gov registry entry for NCT04301765 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 230 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 3 conditions, with Cancer appearing as the primary indexed condition, and to 2 interventions — of which testosterone 1.62% gel 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: NCT04301765 reports 3 study locations spanning 3 distinct geographic areas — top geographies include Georgia, 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 NCT04301765 about?

NCT04301765 is a clinical study titled "Improving Cancer-related Fatigue, Sexual Dysfunction and Quality of Life in Older Men With Cancer and Androgen Deficiency". This is a large randomized, double-blind, placebo-controlled trial to determine the efficacy of testosterone replacement on cancer-related fatigue in older men with solid or hematologic (blood) cancer who report fatigue and have low testosterone levels.

What is the current status of trial NCT04301765?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 230 participants. The study started on 2021-01-12. Estimated completion is 2026-01-31.

What conditions does trial NCT04301765 study?

This clinical trial studies the following conditions: Cancer, Fatigue, Hypogonadism, Male. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04301765?

The interventions under investigation include: testosterone 1.62% gel (DRUG), placebo gel (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04301765?

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 NCT04301765 being conducted?

This trial has 3 study locations across Georgia, Massachusetts, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

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