E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The patient with diagnosis: Hodgkin disease and leukaemia. Patients starting at adolescence (B3 - B4 for breast development accordig Tanner criteria) till 34 years be included.
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MedDRA Classification |
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 |
AIM OF THE PROJECT
Achievement and maintenance of transitory and targeted protective suppression of reproduction axis during antitumour treatment
Observation of gonadal function after treatment termination
Assessment of reproduction functions and of fertility after treatment
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E.2.2 | Secondary objectives of the trial |
Assessment of protective influence of pharmacological gonadal protection on occurrence of severe metrorrhagias during antitumour treatment |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Female subjects with normal gonadal function and with first manifestation of malign disease (Hodgkin lymphoma and leukaemia), who will undergo cytostatic treatment with high risk of gonadal damage and who are interested in fertility.
Female subjects in fertile period (starting with perimenarcheal period B3-B4 acording Tanner criteria) till 34 years of age
With one of following malign diseases: acute lymphoblastic leukemia, acute myeloblastic leukemia, Hodgkin’s lymphoma
Not yet treated for malign disease, with normal ovarian functions
Signed informed consent
No hormonal replacement 3 months before initiation of the study
No hormonal contraception before first injection of study medication
In the case of oocyte harvesting and cryopreservation of oocytes after hormonal stimulation (for the future IVF) last menstrual bleeding must folow
Pregnancy test must be negative
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E.4 | Principal exclusion criteria |
Subjects undergoing transplantation of hemopoetic blood cells and / or whole body irradiation
Subjects without uterus
Subjects with contraindication of gravidity
Subjects without fertility interest
Subjects with abormal gonadal function 6 months before the onset of study
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E.5 End points |
E.5.1 | Primary end point(s) |
Detection of gonadal damage |
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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 | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | 4 |
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 | Information not present in EudraCT |
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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Detection of gonadal damage (high levels of FSH), amenorrhea 4 months and more and high level of FSH |
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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 | 4 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |