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Testosterone gel trial aims to beat cancer fatigue in older men

NCT ID NCT04301765

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 230 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2021

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

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

55 years and older

Sex

Male participants only

Healthy volunteers

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

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

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • Georgia Cancer Center at Augusta University

    Augusta, Georgia, 30912, United States

  • Veterans Affairs Puget Sound Health Care System

    Seattle, Washington, 98108, United States

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