Phase 2 Chronic Fatigue Syndrome Trial, Recruiting NCT04049331 Sponsor: Seattle Institute for Biomedical and Clinical Research Condition: Chronic Fatigue Syndrome
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Phase 2 Chronic Fatigue Syndrome Trial, Recruiting

NCT04049331
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are a cancer survivor who received chemotherapy and/or radiation therapy and have been in remission for at least one year
  • Your cancer was not hormone-dependent — this includes most solid tumors, lymphomas, and leukemias
  • You are a male between 18 and 54 years old
  • Your testosterone levels (measured by a specific blood test) are below a certain threshold, meaning your testosterone may be lower than normal for your age
  • You are experiencing fatigue, measured by a specific questionnaire score that indicates your tiredness is significant enough to affect daily life
  • You are willing and able to give informed consent to participate

Who may not be able to join:

  • Men who had hormone-dependent cancers such as breast cancer, prostate cancer, or an unknown cancer that may be hormone-dependent
  • Men who have had brain cancer, due to concerns about thinking and memory
  • Men who have used testosterone, DHEA, growth hormone, or similar muscle/hormone-boosting substances in the past 6 months
  • Men who have used appetite-stimulating medications (such as megestrol acetate) in the past 6 months
  • Men who have taken steroid medications (such as prednisone at higher doses) for more than two weeks in the past 6 months
  • Men whose red blood cell levels (hematocrit) are above a certain level on a blood test
  • Men with elevated PSA levels on a blood test (a marker related to prostate health), with different thresholds depending on ethnicity
  • Men who have a father, son, or brother with a history of prostate cancer
  • Men with heart failure that is not well controlled
  • Men with severe sleep apnea that has not been treated
  • Men who have had a heart attack, serious heart event, heart surgery, or stroke within the past 3 months — or a previous stroke that left lasting problems with memory or physical function
  • Men with certain abnormal kidney or liver blood test results
  • Men with poorly controlled diabetes or a body mass index (BMI) over 45
  • Men with depression that is currently untreated (those receiving treatment for depression, whether through medication or counselling, may still be eligible)
  • Men diagnosed with bipolar disorder or schizophrenia

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Jose M Garcia, MD, PhD, VA Puget Sound Health Care System

Phone: 206 764 2984

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Seattle Institute for Biomedical and Clinical Research
Registry
ClinicalTrials.gov
Start date
22 March 2021
Est. completion
30 January 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Fatigue change

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov