E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
endometriosis |
endometriosi |
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E.1.1.1 | Medical condition in easily understood language |
endometriosis |
endometriosi |
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E.1.1.2 | Therapeutic area | Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13] |
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 | 10014789 |
E.1.2 | Term | Endometriosis, site unspecified |
E.1.2 | System Organ Class | 100000004872 |
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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 |
To assess the bioavailability of VML-0501 in comparison to oral Danazol in terms of: - Concentrations in serum - Concentrations in peritoneal fluid.
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Stabilire la biodisponibilit¿ di VML-0501 in confronto a Danazol orale in termini di - Concentrazione nel siero - Concentrazione nel fluido peritoneale
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E.2.2 | Secondary objectives of the trial |
Secondary study outcome: - Concentration in endometrial tissue found outside the uterus (Lesion tissue)
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Risultati secondari: -Concentrazione nel tessuto endometriale situato all¿esterno dell¿utero (lesione)
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
The subject must: • Provide written (personally signed and dated) informed consent before completing any study-related procedure, which means any assessment or evaluation that would not have formed a part of her normal medical care. • Be a female with signs and symptoms of endometriosis • Greater than or equal to 18 years of age and less than 42years. • Scheduled to undergo laparoscopy. • According to the local practice the women should sign a specific clause on avoiding pregnancy based on the use of two effective methods for birth control (condom and spermicidal) following 30 days after the last dose/application. • Be non-pregnant undergoing laparoscopy with signs and symptoms of endometriosis within first 10 days of her cycle. • Have a body mass index (BMI) < 32 kg/m2
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Il soggetto deve: • Fornire un consenso informato (firmato personalmente e datato) prima di iniziare qualsiasi procedura relativa allo studio, che significa qualsiasi accertamento o valutazione che non avrebbe fatto parte della sua normale cura medica. • Avere segni e sintomi di endometriosi • Avere un’età maggiore o uguale a 18 anni e minore di 42. • Essere in lista per un intervento di laparoscopia. • In conformità alla pratica locale le donne dovrebbero firmare una specifica clausola per evitare una gravidanza basandosi sull’uso di due efficaci metodi per il controllo delle nascite (profilattico e spermicida) continuando per 30 giorni dall’ultima dose/applicazione del prodotto medicinale oggetto dello studio. • Non essere in stato di gravidanza al momento di sottoporsi alla laparoscopia, con segni e sintomi di endometriosi, entro i primi 10 giorni del ciclo mestruale. • Avere un indice di massa corporea (BMI) = 32 kg/m2
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E.4 | Principal exclusion criteria |
If any of the following criteria apply, the subject MUST NOT be admitted/continue the study trial. The subject: • Is pregnant (if positive-Urine pregnancy test at screening) or lactating; • Has evidence of drug or alcohol abuse. • Have used hormonal replacement therapy or Danazol therapy within the past 8 weeks before study entry • Has any of the following: Epileptic Seizure, Migraine Headache, Angina, Chronic Heart Failure, Obstruction of a Blood Vessel by a Blood Clot, Liver Problems, Kidney Disease, Pregnancy, Combined High Blood Cholesterol and Triglyceride Level, Porphyria • Undiagnosed abnormal genital bleeding • Androgen dependant tumour • Is Allergic to anabolic androgenic steroid. • Smoker.
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Se si applica anche uno dei seguenti criteri, il soggetto NON DEVE essere ammesso alla studio o continuare la sperimentazione. Il soggetto: • stato di gravidanza allo screeinig ( positiva al test di gravidanza sulle urine) o se allatta. • Assume droghe o abusa di alcool. • Ha seguito una terapia ormonale sostitutiva o una terapia con Danazol nelle ultime 8 settimane precedenti l’arruolamento nello studio. • Ha alcuni dei seguenti disturbi: crisi epilettiche, emicrania, angina, insufficienza cardiaca cronica, ostruzione di un vaso sanguigno a causa di un coagulo di sangue, problemi epatici, malattie renali, gravidanza, alti livelli di colesterolo e trigliceridi, porfiria. • Sanguinamento genitale anomalo non diagnosticato. • Tumore androgeno dipendente. • È allergica a steroidi androgeni anabolizzanti • Fumatrice |
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E.5 End points |
E.5.1 | Primary end point(s) |
To assess the bioavailability of VML-0501 in comparison to oral Danazol in terms of Concentrations in serum, concentrations in peritoneal fluid.
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Stabilire la biodisponibilità di VML-0501 in confronto a Danazol orale in termini di concentrazione nel siero e Concentrazione nel fluido peritoneale
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
5 - 7 days treatment |
5-7 giorni di trattamento |
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E.5.2 | Secondary end point(s) |
To assess the bioavailability of VML-0501 in comparison to oral Danazol in terms of concentration in endometrial tissue found outside the uterus (Lesion tissue)
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Stabilire la biodisponibilit¿ di VML-0501 in confronto a Danazol orale in termini di Concentrazione nel tessuto endometriale situato all¿esterno dell¿utero (lesione)
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
5-7 days treatment |
5-7 giorni di trattamento |
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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 | No |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
To determine serum concentrations, Concentrations in peritoneal fluid and in endometrial tissue found outside the uterus (Lesion tissue) |
Stabilire concentrazione nel siero, nel fluido peritoneale, nel tessuto endometriale situato all¿esterno dell¿utero (lesione)
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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 | Yes |
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 | 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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Stesso farmaco in forma farmaceutica diversa. |
Same drug with different farmaceutical form |
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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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 1 |
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 | 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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |