A Phase 2 interventional study of Testosterone Undecanoate 750 MG/3 ML Intramuscular Solution [AVEED] and placebo in Hypogonadism, Male and Fatigue Syndrome, Chronic, sponsored by Seattle Institute for Biomedical and Clinical Research. Recruiting at 2 sites in United States. Open to male participants aged 18 Years to 54 Years. Per ClinicalTrials.gov, last updated 2026-06-22.
Sponsored by Seattle Institute for Biomedical and Clinical Research · Phase 2, Interventional, and Treatment
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.
The overall goal of this proposal is to evaluate the efficacy of testosterone replacement therapy in improving fatigue and other outcomes such as sexual function, quality of life, body composition, muscle strength and physical activity in a double-blind, randomized, placebo-controlled trial in young cancer survivors who report fatigue and have testosterone deficiency.
Fatigue is one of the most prevalent and debilitating symptoms in men with cancer affecting 70-100% of patients irrespective of their age. Cancer-related fatigue is experienced by patients not only during active cancer treatment, but is also highly prevalent in cancer survivors who exhibit persistent fatigue months to years after the end of their treatment with the highest prevalence being in recipients of chemotherapy and/or radiation therapy.
In addition to fatigue, sexual dysfunction is also highly prevalent in male cancer survivors. Male cancer survivors also have increased fat mass and decreased lean body mass, a phenotype that predisposes them to reduced muscle strength. This phenotype of fatigue, sexual dysfunction and adverse body composition is commonly encountered in non-cancer patient populations with testosterone deficiency, a condition which is also highly prevalent (50-90%) in cancer survivors. Pivotal trials of testosterone replacement therapy in non-cancer patient populations have shown an improvement in fatigue, sexual function and body composition in men randomized to testosterone compared with placebo. However, the efficacy of testosterone replacement therapy on cancer-related fatigue has not been studied.
Exclusion Criteria:
Myocardial infarction, acute coronary syndrome, revascularization surgery, or stroke within 3 months
o Previous stroke with residual cognitive or functional deficits; Mini-Mental State Examination score \<24
Testosterone undecanoate injection 750 MG/3 ML
Drug: Testosterone Undecanoate 750 MG/3 ML Intramuscular Solution [AVEED]
clinical grade saline 0.9% sodium chloride injection
Other: placebo
first two doses four weeks apart; following three more doses every ten weeks.
Also known as: study drug
first two doses four weeks apart; following three more doses every ten weeks.
Fatigue change
(Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F) questionnaire
Time frame: 9 months
Sexual function change
Harbor-UCLA 7-day Sexual Function Questionnaire
Time frame: 9 months
Sexual function change
International Index of Erective Function (IIEF) questionnaire
Time frame: 9 months
Body composition change
Lean body mass and fat mass (kg) measured by dual energy x-ray absorptiometry (DEXA)
Time frame: 9 months
Changes to mood and well-being
Mood and well-being will be assessed by the Positive and Negative Affect Scale (PANAS) affectivity balance scale, which includes 10 questions each for Positive Affect and Negative Affect. Many behavioral scientists consider affectivity as the cleanest window on an individual's wellbeing. The most sensitive indicator of impaired wellbeing has been shown to be affective dysregulation, which is reflected in affectivity balance. The latter incorporates negative affects (e.g., anxiety, depression) as well as positive affects (e.g., joy).
Time frame: 9 months
Muscle strength change
Maximal voluntary muscle strength in the lower extremities will be assessed by conducting the leg press exercise by the 1-repetition maximum method and assessing loaded stair climb power.
Time frame: 9 months
Sleep quality change
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 9 months
Sleep quality change
Insomnia Severity Index (ISI)
Time frame: 9 months
Sleep quality change
Actigraphy
Time frame: 9 months
Daily physical activity change
Validated triaxial accelerometry (actigraphy)
Time frame: 9 months
Plan to share: No
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Seattle Institute for Biomedical and Clinical Research