Hypogonadism, Male study: Testosterone Undecanoate
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)?
An investigational injectable medicine being studied as a potential treatment for fatigue, sexual function, quality of life, body composition, muscle strength, and physical activity in young male cancer survivors with hypogonadism. It is designed to replace low testosterone and raise testosterone levels in the body.
Also referred to as testosterone undecanoate, Depo-Testosterone.
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 study wants to find out whether giving testosterone improves fatigue, sexual function, quality of life, body composition, muscle strength, and activity levels compared with a placebo.
- Who it's for
- Young men who have finished cancer treatment at least a year ago, feel fatigued, and have low testosterone levels.
- What's involved
- Participants will receive either a testosterone injection (Depo‑Testosterone) or a placebo and will have regular visits for fatigue questionnaires, physical tests, and safety checks.
- 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.
- Self-reported fatigue. We have selected these symptoms because they are commonly reported in male cancer survivors.
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.
- Self-reported fatigue. We have selected these symptoms because they are commonly reported in male cancer survivors.
- 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 is enrolling
- 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, but 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?
This study is enrolling now at Boston, Massachusetts, United States; Seattle, Washington, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.