E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Pre-menopausal women 18 years and older with confirmed endometriosis and moderate to severe endometriosis-associated pelvic pain (EAPP), otherwise in good general health. |
Mujeres premenopáusicas de 18 años o más con endometriosis confirmada y dolor pélvico asociado a la endometriosis (DPAE) de moderado a severo, por lo demás con buena salud general. |
|
E.1.1.1 | Medical condition in easily understood language |
Women, 18 years or older with symptomatic endometriosis |
Mujeres de 18 años o más con endometriosis sintomática |
|
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 | PT |
E.1.2 | Classification code | 10014778 |
E.1.2 | Term | Endometriosis |
E.1.2 | System Organ Class | 10038604 - Reproductive system and breast disorders |
|
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 primary objective of this study is to assess the efficacy and safety of two doses of vilaprisan compared to placebo in women with symptomatic endometriosis |
El objetivo principal del estudio es evaluar la eficacia y la seguridad de dos dosis de vilaprisán en comparación con placebo en mujeres con endometriosis sintomática. |
|
E.2.2 | Secondary objectives of the trial |
The secondary objective of this study is to evaluate the safety and tolerability of two different doses of vilaprisan in women with symptomatic endometriosis |
El objetivo secundario del estudio es evaluar la seguridad y la tolerabilidad de dos dosis diferentes de vilaprisán en mujeres con endometriosis sintomática. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Signed and dated informed consent 2. Pre-menopausal women 18 years (inclusive) and above at the time of Visit 1 3. Women with endometriosis confirmed by laparoscopy or laparotomy OR diagnosed based on imaging 4. Moderate to severe endometriosis-associated pelvic pain (EAPP) 5. Adherence to screening period diary entries 6. Willingness to use only standardized pain medication if needed 7. Good general health (except for findings related to endometriosis) 8. Normal or clinically insignificant cervical cytology not requiring further follow-up 9. An endometrial biopsy performed at the screening phase without significant histological disorder 10. Use of an acceptable non-hormonal method of contraception 11. Willingness / ability to comply with electronic diary entry for the duration of study participation |
1. Consentimiento informado firmado y fechado 2. Edad: mujeres premenopáusicas de 18 años (inclusive) o más en el momento de la visita 1 3. Mujeres con endometriosis confirmada con laparoscopia o laparotomía o diagnosticada según estudios de imagen 4. Dolor pélvico asociado a la endometriosis (DPAE) de moderado a severo 5. Cumplimiento con la cumplimentación del diario durante el período de selección 6. Disposición para usar solo analgésicos estandarizados si es necesario 7. Buen estado de salud general (exceptuando los hallazgos relacionados con la endometriosis) 8. Citología vaginal normal o clínicamente no significativa, que no requiere seguimiento posterior 9. Biopsia endometrial realizada durante la fase de selección, sin alteraciones histológicas significativas 10. Uso de un método anticonceptivo no hormonal aceptable 11. Disposición/capacidad para cumplir con la entrada en el diario electrónico durante toda la participación en el estudio |
|
E.4 | Principal exclusion criteria |
1. Pregnancy or lactation (less than 3 months since delivery, abortion, or lactation before Visit 1) 2. Hypersensitivity to any ingredient of the study treatments 3. Laboratory values outside the inclusion range before randomization, and considered clinically relevant 4. Any diseases or conditions that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study drug including abnormal liver parameters 5. Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results 6. Undiagnosed abnormal genital bleeding 7. Abuse of alcohol, drugs, or medicines (e.g. laxatives) as evaluated by the investigator 8. Use of other treatments that might interfere with the conduct of the study or the interpretation of the results 9. Endometriosis-specific treatments for symptom relief except rescue pain medication according to protocol 10. Simultaneous participation in another clinical trial with investigational medicinal product(s). Participation in another trial prior to study entry that might have an impact on the study objectives, at the discretion of the investigator 11. Inability to cooperate with the study procedures for any reason 12. Previous assignment to treatment (e.g. randomization) during this study (allowing previously randomized subjects to be re-included into the study may lead to bias) 13. Hypersensitivity to any ingredient of standardized pain medication 14. Wish for pregnancy during the study 15. Regular use of pain medication due to other underlying diseases 16. Non-responsiveness of EAPP to GnRH-a |
1. Embarazo o lactancia (si han transcurrido menos de 3 meses desde el parto, aborto o lactancia antes de la visita 1). 2. Hipersensibilidad a cualquier componente de los tratamientos del estudio. 3. Resultados de las analíticas que estén fuera del rango de inclusión antes de la aleatorización y que se consideren clínicamente relevantes. 4. Cualquier enfermedad o trastorno que pueda alterar la función de los órganos, sistemas y aparatos corporales y pudiera ocasionar una acumulación excesiva o una alteración de la absorción, del metabolismo o de la excreción del fármaco del estudio incluyendo parámetros hepáticos anormales 5. Cualquier enfermedad o trastorno que pudiera interferir en la realización del estudio o la interpretación de los resultados 6. Sangrado genital anómalo no diagnosticado 7. Abuso de alcohol, drogas o medicamentos (p. ej., laxantes) según el investigador 8. Uso de otros tratamientos que pudieran interferir en la realización del estudio o la interpretación de los resultados 9. Tratamientos específicos para la endometriosis para el alivio de los síntomas, excepto medicación analgésica de rescate según el protocolo 10. Participación simultánea en otro estudio clínico con fármacos en investigación. Participación en otro estudio clínico antes de la entrada en el estudio que pudiera afectar a los objetivos del estudio, según el criterio del investigador 11. Imposibilidad de colaborar con los procedimientos del estudio por cualquier motivo 12. Asignación previa a un tratamiento (p. ej., aleatorización) durante este estudio (las pacientes previamente aleatorizadas a las que se vuelva a incluir en el estudio pueden provocar un sesgo) 13. Hipersensibilidad a cualquier componente de los analgésicos estandarizados 14. Deseo de quedar embarazada durante el estudio 15. Uso regular de analgésicos debido a otras enfermedades subyacentes 16. Falta de respuesta del DPAE a GnRH-a. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Change in the subject’s 7-day mean ‘worst pain’ from baseline to Month 3 of the first 24-week treatment period measured on a daily NRS. |
Cambio en la media de 7 días del «peor dolor» de la paciente desde el inicio hasta el mes 3 del primer período de tratamiento de 24 semanas determinado mediante una EVN (escala de valoración numérica) diaria |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
The proportion of subjects with an improvement on dysmenorrhea AND the proportion of subjects with an improvement on non-menstrual pelvic pain, from baseline and no increase in rescue pain medication use. |
La proporción de pacientes con una mejoría en la dismenorrea Y la proporción de pacientes con una mejoría en el dolor pélvico no menstrual, desde el inicio y sin aumento en el uso de medicamentos analgésicos de rescate. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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 | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
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 | 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 | 3 |
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 | 7 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 27 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Austria |
Bulgaria |
Canada |
China |
Czech Republic |
Denmark |
Finland |
Germany |
Hungary |
Italy |
Japan |
Poland |
Portugal |
Spain |
Sweden |
Switzerland |
Taiwan |
United States |
|
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
|
LPLV |
Último paciente última visita |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | 26 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 8 |
E.8.9.2 | In all countries concerned by the trial days | 26 |