Study of Testosterone vs Placebo in Testicular Cancer Survivors (NCT02991209) | Clinical Trial Compass
CompletedPhase 2/3
Study of Testosterone vs Placebo in Testicular Cancer Survivors
Denmark69 participantsStarted 2016-11
Plain-language summary
The overall purpose of the study is to evaluate the effect of 12 months testosterone replacement therapy in testicular cancer survivors with mild Leydig Cell Insufficiency in order to reduce the risk of cardiovascular disease.
The primary study objective is to evaluate changes in insulin sensitivity. The secondary study objective is to evaluate changes in the prevalence of metabolic syndrome, body composition, systemic inflammation and symptoms of testosterone deficiency.
Who can participate
Age range
18 Years – 65 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Signed informed consent.
* Previous treatment for testicular cancer.
* No signs of relapse 1 year after last treatment (orchiectomy, radiotherapy, chemotherapy).
* Free testosterone \< the age-adjusted median and \> -2 standard deviations (SD) from the age-adjusted median and LH \> 2 SD from the age-adjusted median.
Exclusion Criteria:
* Treatment with testosterone within the last 6 months.
* Contraindications to testosterone treatment (prostate cancer, prostate specific antigen (PSA)\> 4 ng/mL), malignancy suspect prostate by digital rectal examination, Alanine aminotransferase (ALT)\> 1.5 upper reference level, Erythrocyte Volume Fraction (EVF) \> 50%.
* Breast cancer.
* Symptomatic obstructive sleep apnoea syndrome
* Heart failure \> NYHA II.
* Uncontrolled hypertension: (Systolic blood pressure \> 160 mm Hg despite antihypertensive treatment, measured at two separate occasions)
* Inability to understand information about the trial
* Participation in any other clinical trial
* Allergy for the active substance or additives in Tostran or placebo.
* Known diabetes mellitus, or diabetes mellitus detected at screening or baseline tests.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.