E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Borderline low levels of testosterone in male cancer survivors who have previously had leukaemia, lymphoma or testicular cancer. |
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E.1.1.1 | Medical condition in easily understood language |
Borderline low levels of testosterone in male cancer survivors who have previously had leukaemia, lymphoma or testicular cancer. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Hormonal diseases [C19] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10047900 |
E.1.2 | Term | Weight loss |
E.1.2 | System Organ Class | 10022891 - Investigations |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The principal research question is to find out whether testosterone replacement therapy can reduce body fat and improve quality of life in young male cancer survivors who have a borderline low level of testosterone. This question is split in to two principal research objectives which are: • To assess the effect of 26 weeks of testosterone treatment on levels of fat within the body • To assess the effect of 26 weeks of testosterone treatment on the participants' physical functioning. This information is collected using questionnaires that are completed by the participant. |
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E.2.2 | Secondary objectives of the trial |
• To assess the effect of 26 weeks of treatment with testosterone gel on lean body mass, whole body fat mass, BMI, waist circumference, blood insulin, glucose, lipid and LH levels and bone density in hypogonadal cancer survivors • To assess the effect of 26 weeks of treatment with testosterone gel on participant self-reported quality of life, fatigue, self-esteem and sexual function scores in hypogonadal cancer survivors |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Able and willing to provide written informed consent • Able and willing to comply with all study procedures • Male • Aged between 25 and 50 years • Post-pubertal • Previous testicular cancer, lymphoma or leukaemia • At least 12 months from completion of curative treatment for testicular cancer, lymphoma or leukaemia • A serum testosterone level ≥7nmol/l and ≤12nmol/l • If taking any hormone replacement, on stable doses for the last 6 months |
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E.4 | Principal exclusion criteria |
• Body Mass Index (BMI) of more than 35 kg/m2 • Currently receiving corticosteroid therapy or likely to receive corticosteroids during the trial • Previous testosterone treatment within 12 months of entering the trial • Previous allogeneic bone marrow transplant • A history of hormone-dependent cancer (e.g. prostate or breast cancer) • A history of primary liver tumour • Previous history of hypercalcaemia • Nephrotic syndrome • Diabetes mellitus (type 1 or type 2) • Hypertension • Heart failure • Liver disease • Renal failure • Deep vein thrombosis • Systolic blood pressure > 100 mmHg diastolic or > 160 mmHg systolic after resting and three measurements - Clinically significant abnormal PSA or FBC • Other severe concurrent disease or mental disorder which would affect the collection of study measurements |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoints are truncal fat mass and the patient-reported SF36™ physical functioning scale at 26 weeks. Truncal fat mass will be measured by whole body dual energy X-ray absorptiometry (DXA). Local quality assurance data and quality of scan images will be centrally reviewed. The SF-36™ is a well validated, multi-purpose standard health-related quality of life (QoL) evaluation questionnaire which will be used to assess generic, self reported QoL. It generates an 8-scale profile of functional health and well-being scores including a physical functioning scale, as well as summary measures of physical and mental health. This information relates to the previous 4 week time period. |
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E.5.2 | Secondary end point(s) |
The secondary research objectives are: • To assess the effect of 26 weeks of testosterone treatment on Body Mass Index, waist circumference, blood insulin, glucose and lipid levels and bone density • To assess the effect of 26 weeks of treatment with testosterone gel on participant self-reported quality of life, fatigue, self-esteem and sexual function scores |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
26 weeks after randomisation |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 10 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of the trial is defined as the date of the last participant's last treatment visit. Long term follow up for the purposes of the Main REC and Research Governance to one month after the last participant's last trial follow up visit constitutes the non-interventional phase of the trial. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 7 |
E.8.9.2 | In all countries concerned by the trial days | 0 |