Hypogonadism, MalePhase 2NCT04049331
Testosterone Replacement in Male Cancer Survivors With Fatigue and Low Testosterone
A Phase 2 study testing Testosterone Undecanoate 750 MG/3 ML Intramuscular Solution [AVEED] in people with Hypogonadism, Male and Fatigue Syndrome, Chronic, run by Seattle Institute for Biomedical and Clinical Research at 2 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 54 years, men only
- Conditions the study is for
- Hypogonadism, Male, Fatigue Syndrome, Chronic
- What is being tested?
- Testosterone Undecanoate 750 MG/3 ML Intramuscular Solution [AVEED]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Mar 2021to 30 Jan 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 54 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Cancer survivors who have received chemotherapy and/or radiation therapy for their cancer and are now in remission for at least one year
- Non-hormone-dependent cancer, including most solid tumors, lymphomas and leukemias
- Age: 18-54 years
- 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 young men (age 19-40 years), is 348 ng/dL and the lower limits of free testosterone is <70 pg/ml in the Framingham Heart Study sample97. Therefore, young symptomatic men with total testosterone <348 ng/dl could be considered testosterone deficient. 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. However; their free testosterone levels may still be below the lower limit of normal. Thus, we will also include men with free testosterone <70 pg/mL.
- Self-reported fatigue. We have selected these symptoms because they are commonly reported in male cancer survivors. Fatigue will be defined as a score on Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) subscale of <40, which best divides cancer patients from the general population with 84% accuracy, and was used as the cut-off for the NIA-funded 50-million-dollar testosterone trial (The T-Trial).
- Ability and willingness to provide informed consent.
Who cannot join
- Men with hormone-dependent cancers (breast, prostate or adenocarcinoma of unknown origin)
- Men with brain cancer (potential cognitive impairment)
- Use of anabolic agents (testosterone, dehydroepiandrosterone, growth hormone) within the past 6 months
- Appetite stimulating agents e.g. megestrol acetate within the past 6 months
- Systemic glucocorticoids e.g. prednisone 20 mg daily or equivalent doses of other glucocorticoids for more than two weeks in the past 6 months
- Baseline hematocrit >48%
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- PSA >4 ng/ml in Caucasians; >3 ng/ml in African-Americans
- Men with 1st order relatives with a history of prostate cancer
- Uncontrolled congestive heart failure
- Severe untreated sleep apnea
- 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
- Serum creatinine >2.5 mg/dL; ALT 3x upper limit of normal
- Poorly controlled diabetes as defined by hemoglobin A1c >8.5%; Body mass index (BMI) >45 kg/m2
- Untreated unipolar depression (treated depression with medications or counseling will be allowed
- Bipolar disorder or schizophrenia
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Milena Braga, MD, 617-525-9144, mbraga@bwh.harvard.edu
Shehzad Basaria, MD
- Recruiting
Veterans Affairs Puget Sound Health Care System
Seattle, Washington, 98108
Gary Miranda, LPN, 2062776143, Gary.Miranda@va.gov
Lindsey Anderson, PhD, 2062776719, Lindsey.Anderson5@va.gov
About this study
Official title: Improving Patient-Important Outcomes With Testosterone Replacement in Hypogonadal Men With a Prior History of Cancer
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.
Read the detailed description
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.
- Conditions
- Hypogonadism, Male, Fatigue Syndrome, Chronic
- Being tested
- Testosterone Undecanoate 750 MG/3 ML Intramuscular Solution [AVEED], placebo
- Keywords
- testosterone, hypogonadism, cancer related fatigue
- Medical subject headings
- Eunuchism, Fatigue Syndrome, Chronic, Hypogonadism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testosterone Undecanoate 750 MG/3 ML Intramuscular Solution [AVEED]Drug
Also called study drug
first two doses four weeks apart; following three more doses every ten weeks.
placeboOther
first two doses four weeks apart; following three more doses every ten weeks.
| Study group | Role | What they receive |
|---|---|---|
| Testosterone | Experimental | Testosterone undecanoate injection 750 MG/3 ML Receives: Drug: Testosterone Undecanoate 750 MG/3 ML Intramuscular Solution [AVEED] |
| Placebo | Placebo comparator | clinical grade saline 0.9% sodium chloride injection Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue change
(Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F) questionnaire
Measured: 9 months
Secondary outcomes (9)
Sexual function change
Harbor-UCLA 7-day Sexual Function Questionnaire
Measured: 9 months
Sexual function change
International Index of Erective Function (IIEF) questionnaire
Measured: 9 months
Body composition change
Lean body mass and fat mass (kg) measured by dual energy x-ray absorptiometry (DEXA)
Measured: 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).
Measured: 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.
Measured: 9 months
Sleep quality change
Pittsburgh Sleep Quality Index (PSQI)
Measured: 9 months
Sleep quality change
Insomnia Severity Index (ISI)
Measured: 9 months
Sleep quality change
Actigraphy
Measured: 9 months
Daily physical activity change
Validated triaxial accelerometry (actigraphy)
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2019
- Study start22 Mar 2021
- Primary completion30 Jan 2027 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypogonadism, MaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seattle Institute for Biomedical and Clinical Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jose M Garcia, MD, PhD, Principal investigator, VA Puget Sound Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04049331
- Sponsor's protocol ID
- 01751
- Status last verified
- Apr 2026
- First submitted
- 23 Jul 2019
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No