Testosterone gel trial aims to beat cancer fatigue in older men
NCT ID NCT04301765
First seen Jun 24, 2026 · Last updated Jul 07, 2026 · Updated 3 times
Summary
This study is testing whether a daily testosterone gel can reduce fatigue and improve sexual function in men aged 55 and older who have cancer and low testosterone. The trial involves 230 participants who will apply either the gel or a placebo for six months. Researchers will measure changes in fatigue and sexual activity using standard questionnaires.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- testosterone gel
- What this could lead to
- If it works, this could offer a way to ease fatigue and improve sexual health in older men with cancer who have low testosterone.
- What could go wrong
- This is a phase 2 trial, so results are still uncertain. Testosterone may not help fatigue, and there are risks like worsening prostate cancer or heart problems.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 230 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2021
- Expected to finish
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Nov 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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55 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Men with active solid or hematologic (blood) cancers who have received or are receiving chemo- and/or radiation therapy. Patients who have no evidence of disease (NED) for 60 months or less, which means that they are \<60 months from their last treatment (chemotherapy and/or radiation therapy) will be included. * Age: 55 years and older * Life expectancy of at least 6 months. * Serum testosterone, measured by mass spectrometry (gold standard method), of \<348 ng/dl and/or free testosterone \<70 pg/ml. The lower limits of the normal range for total testosterone in healthy men is 348 ng/dL and the lower limits of free testosterone is \<70 pg/ml in the Framingham Heart Study sample. As sex hormone binding globulin levels may be elevated in some men with cancer (resulting in elevation in total testosterone level), some of these symptomatic men may still be hypogonadal despite having total testosterone above this cut-off limit, but their free testosterone levels may still be below the lower limit of normal. Thus, men with free testosterone \<70 pg/mL will be included. * Fatigue. Fatigue was selected as it is a highly prevalent symptom in cancer patients. Fatigue will be defined as a score on FACIT-Fatigue subscale of \<40, which best divides cancer patients from the general population with accuracy. * Ability and willingness to provide informed consent Exclusion Criteria: * Men with current or prior history of prostate, breast, testicular, or adrenal cancers. * Use of anabolic agents (testosterone, DHEA, growth hormone) within the past 6 months * Hematocrit \>48%, serum creatinine \>2.5 mg/dL * PSA \>4 ng/ml; nodule or induration on digital rectal exam * Severe untreated sleep apnea * Uncontrolled congestive heart failure * Myocardial infarction, acute coronary syndrome, revascularization surgery, stroke or thromboembolism (of any etiology) within 6 months * Known history of thrombophilia due to a genetic mutation (e.g. Factor V Leiden) * Previous stroke with residual cognitive or functional deficits * Inability to provide informed consent; MMSE score \<24 * Poorly controlled diabetes as defined by hemoglobin A1c \>10.0% * Body mass index (BMI) \>40 kg/m2 * Bipolar disorder or schizophrenia
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
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Georgia Cancer Center at Augusta University
Augusta, Georgia, 30912, United States
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Veterans Affairs Puget Sound Health Care System
Seattle, Washington, 98108, United States
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