E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
Low levels of testosterone in the blood, with symptoms corresponding the low serumlevel. |
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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 | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10043335 |
E.1.2 | Term | Testicular hypogonadism |
E.1.2 | System Organ Class | 100000004860 |
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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 approach to surveillance and treatment of gonadal dysfunction following remission with first line therapy for malignant lymphoma remains controversial. With a paucity of evidence whether follow-up programs and treatment are effective, evidence-based guidelines for follow-up and treatment of gonadal dysfunction are needed. The main purpose of the current study is to assess the extent of sexual dysfunction, quality of life (QoL) and reduced levels of testosterone in male patients with Hodgkin lymphoma (HL) and diffuse large B-cell lymphoma (DLBCL). Furthermore, in a prospective phase 2 study, to test the impact on QoL before and after substitution with testosterone in patients with reduced levels of testosterone. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Age 18-65 years at inclusion Male Verified diagnosis of de novo DLBCL or classical HL diagnosed between april 2013 and april 2018 according to WHO classification. Disease in complete remission for at least 2 years at inclusion. Completed curative intent first line treatment with anthracycline-containing chemotherapy with or without consolidating radiotherapy Literate in Danish Serum testosterone level below age-adjusted reference level.
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E.4 | Principal exclusion criteria |
Concurrent low-grade lymphoma Current or prior lymphoma of the central nervous system (CNS) Current or prior lymohoma of the testes Verified prostate cancer, cancer of the mammae, primary liver cancer-related, polycythaemia vera Mental or physical conditions that are expected to prevent the necessary "compliance" and/or "adherence" in relation to the study procedures Contraindications for the treatment with testosterone: PSA > 3 ng/ml, Hct > 0,49 Treatment with second line chemotherapy or high dose therapy. Current or prior anabolic steroid abuse Known sexual dysfunction prior to enrolment.
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E.5 End points |
E.5.1 | Primary end point(s) |
Effect of treatment with testosterone (Testogel) on QLQ C30 score. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
At baseline, after 1,3,6 and 12 months. |
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E.5.2 | Secondary end point(s) |
Effect of treatment with testosterone on SHQ-C22 score. Effect of treatment with testosterone on IIEF-5 score S-testosterone Testosterone dose needed
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
At baseline and after 1,3,6 and 12 months. |
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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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
The patients own data from a prior retrospective study |
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E.8.2.4 | Number of treatment arms in the trial | 1 |
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 | 3 |
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 | No |
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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End of trial is 7 days after the last visit. Patients then have one week to contact us in case of side effects after end of treatment, or before receiving their first visits with the endocrinologist for further treatment. |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | 7 |