A Phase 2 interventional study of Androgel (Testosterone gel) and Placebo gel in Testicular Cancer, sponsored by University Medical Center Groningen. Completed at 1 site in Netherlands. Open to male participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2024-07-30.
Sponsored by University Medical Center Groningen · Phase 2, Interventional, and Prevention
To assess the effects of testosterone replacement therapy on fat mass and other components of the metabolic syndrome. A randomized double-blind placebo controlled intervention study, followed by an open-label treatment phase. Results of this pilot study will be used to design a multicenter randomized controlled study in a large group of TC survivors
Rationale: Testicular cancer (TC) survivors have an increased risk of hypogonadism (decreased testosterone and/or increased luteinizing hormone levels) and cardiovascular disease (CVD). Metabolic syndrome develops early after chemotherapy in 20-30% of long-term TC survivors and is associated with an increased risk of atherosclerotic disease in the general population. TC survivors who develop the metabolic syndrome have a higher body mass index (BMI) pretreatment, a larger BMI increase during follow-up, and lower total testosterone levels than patients without the metabolic syndrome. Testosterone replacement therapy as a short-term intervention during a limited time period may be an important strategy to reduce body weight and fat mass, restore cardiometabolic balance, and decrease the prevalence of the metabolic syndrome in TC survivors.
Objective: to assess the effects of testosterone replacement therapy on fat mass and other components of the metabolic syndrome.
Study design: randomized double-blind placebo controlled intervention study, followed by an open-label treatment phase. Results of this pilot study will be used to design a multicenter randomized controlled study in a large group of TC survivors
Study population: 40 TC patients, aged 18-55 years, at least 12 months after completion of curative treatment with unilateral orchidectomy and platinum-based chemotherapy, and having a fasting total testosterone level ≤12 nmol/l and a BMI ≥25 kg/m2.
Intervention: Patients will be randomized to treatment with transdermal testosterone gel (Androgel) or placebo gel once daily during 20 weeks, followed by 20 weeks of active Androgel treatment in all participants. The treatment dose will be 50 mg daily, adjusted to 25 mg in case of increased testosterone concentrations (average of 2 measurements >25 nmol/L) or signs of overdosing. Patients will be stratified according to testosterone level (8-12 nmol/L versus \<8 nmol/L) and BMI (25-30 kg/m2 versus 30-35 kg/m2).
Main study parameters/endpoints: Primary endpoint is the change in fat mass as measured by Dual-Energy X-ray Absorption (DEXA) scan after 20 weeks of Androgel compared to placebo. Secondary endpoints are changes in fat mass between 20 and 40 weeks, and changes in abdominal visceral fat, BMI, adipocytokines, metabolic syndrome parameters, bone mass density, semen quality, sexual function, and quality of life between Androgel and placebo-treated patients.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The study will provide an answer to the question whether testosterone replacement therapy as a short-term intervention has significant effects on obesity and fat metabolism and may, thus, reduce the prevalence of the metabolic syndrome in this population of young men with excellent long-term cancer-related prognosis, but an increased CVD risk. At various time points during the intervention, patients will be subjected to history taking and physical examination. Furthermore, blood will be drawn to: measure hormone levels, adipocytokines, lipids, glucose, insulin, and bone markers; to extract DNA for determination of gene polymorphisms; and to measure hematocrit and PSA as safety parameters. Semen analysis and a full body DEXA scan will be performed at 0, 20 and 40 weeks only. Patients will be asked to fill out questionnaires regarding quality of life, sexual health, and androgen deficiency symptoms at various time points during the intervention.
295 studies on the registry are indexed under Testicular Neoplasms; 51 are open to participants now.
This study's enrollment of 32 is below the median of 50 across 190 interventional studies indexed under Testicular Neoplasms.
Browse Testicular Neoplasms studies →University Medical Center Groningen is the lead sponsor of 627 studies on the registry; 176 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Eligible for actual study participation and randomization between Androgel and placebo will be:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will be randomized to treatment with transdermal testosterone gel (Androgel) once daily during 20 weeks, followed by 20 weeks of active Androgel treatment in all participants.
Drug: Androgel (Testosterone gel)
Patients will be randomized to treatment with placebo gel once daily during 20 weeks, followed by 20 weeks of active Androgel treatment in all participants.
Drug: Androgel (Testosterone gel) · Drug: Placebo gel
Patients will be randomized to treatment with transdermal testosterone gel (Androgel) once daily during 20 weeks, followed by 20 weeks of active Androgel treatment in all participants.
Also known as: Androgel
Patients will be randomized to treatment with transdermal placebo gel once daily during 20 weeks, followed by 20 weeks of active Androgel treatment in all participants.
Also known as: Placebo
percent change in fat mass as measured using using full body dual X-ray absorptiometry
To assess the effects of 20 weeks of treatment with testosterone gel on fat mass as measured using full body dual X-ray absorptiometry (DEXA scan).
Time frame: 20 weeks of treatment
Effect of treatment with testosterone gel
To assess the effects of 20 and 40 weeks of treatment with testosterone gel on obesity
Time frame: 20 and 40 weeks of treatment
Effect of treatment with testosterone gel
To assess the effects of 20 and 40 weeks of treatment with testosterone gel on signs and symptoms of hypogonadism
Time frame: 20 and 40 weeks of treatment
Plan to share: No
No publications or documents are linked to this record.
Ran from Dec 2018 to primary completion in Jun 2024, 66 months.
Of 17 phase 2 interventional studies under Testicular Neoplasms, half reached primary completion within 51 months of starting (the median), counting those still running; a quarter within 38 and three quarters within 83. This study's 66 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Testosterone
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