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New treatment option for Hypogonadism, Male
Official title Testosterone Replacement in Male Cancer Survivors With Fatigue and Low Testosterone
ClinicalTrials.gov ID: NCT04049331
What this study is testing
What is Testosterone Undecanoate 750 MG/3 ML Intramuscular Solution [AVEED]?
Testosterone Undecanoate 750 MG/3 ML Intramuscular Solution [AVEED] is an investigational medicine, being studied as a potential treatment for hypogonadism, male.
Also referred to as study drug.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 54, men only
You may be able to join if
- 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...
- Self-reported fatigue. We have selected these symptoms because they are commonly reported in male cancer survivors. Fatigue will be defined as a...
You likely can't join if
- 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%
See the full eligibility criteria
- 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...
- 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...
- Ability and willingness to provide informed consent.
- 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%
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years to 54 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States; Seattle, Washington, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.