E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Moderate to Severe Endometriosis Associated Pain |
Dolor moderado a severo asociado a endometriosis |
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E.1.1.1 | Medical condition in easily understood language |
Endometriosis Associated Pain |
Dolor asociado a endometriosis |
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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 | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10014788 |
E.1.2 | Term | Endometriosis related pain |
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 evaluate the safety, tolerability and efficacy of elagolix (ABT-620), administered once daily (QD) or twice daily (BID) for 3 months in the management of moderate to severe endometriosis-associated pain, and to evaluate the effect of elagolix treatment on analgesic use for endometriosis-associated pain. |
Evaluar la seguridad, la tolerabilidad y la eficacia del elagolix (ABT-620), administrado una vez al día (QD) o dos veces al día (BID) durante 3 meses, en el manejo del dolor de moderado a severo asociado a endometriosis y evaluar el efecto del tratamiento con elagolix en el uso de analgésicos para el dolor asociado a endometriosis. |
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E.2.2 | Secondary objectives of the trial |
Evaluation of persistence of efficacy at 6 months, and assessments of other endometriosis-related symptoms, analgesic use, as well as quality of life (QoL) endpoints. |
Evaluar la persistencia de la eficacia a los 6 meses y las evaluaciones de otros síntomas relacionados con la endometriosis, del uso de analgésicos y de criterios de valoración de la calidad de vida (QoL). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1.) Premenopausal female, between 18 and 49 years of age, inclusive, at time of signing consent. 2.) Clinical diagnosis of endometriosis (laproscopy or laparotomy) performed within 7 years of entry into the Washout Period. 3.) Agrees to use required birth control methods during the entire length of participation in the study. 4.) Subject has a Composite Pelvic Signs and Symptoms Score total score of ? 6 at Screening with a score of at least 2 for dysmenorrhea AND at least 2 for non-menstrual pelvic pain. 5.) Subjects must have at least two regular menstrual cycles (28 days ± 5 days) within the Screening Period, immediately prior to Day 1. |
1) Mujer premenopáusica, de entre 18 y 49 años inclusive, al momento de firmar el consentimiento. 2.) Presenta un diagnóstico clínico de endometriosis (laparoscopía o laparotomía) realizada en el término de 7 años antes del ingreso en el período de reposo farmacológico. 3) Aceptar usar los métodos anticonceptivos requeridos durante el periodo completo de participación en el estudio. 4) Puntaje total en la Escala compuesta de signos y síntomas pélvicos ?6 en la selección, con un puntaje de, al menos, 2 para dismenorrea Y de, al menos, 2 para dolor pélvico no menstrual. 5) Tener, al menos, dos ciclos menstruales regulares (28 días ± 5 días) dentro del período de selección, inmediatamente antes del Día 1. |
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E.4 | Principal exclusion criteria |
1.) Subject is pregnant or breast feeding or is planning a pregnancy within the next 24 months or is less than 6 months postpartum, post-abortion, or post-pregnancy at the time of entry into the Screening Period 2.) Subject has a history of previous non-response to GnRH agonists, GnRH antagonists, Depot Medroxyprogesterone Acetate, or aromatase inhibitors as assessed by subject report of no improvement in dysmenorrhea or non-menstrual pelvic pain (subject report of partial response to or side effects from these agents is not exclusionary). 3.) Subject has chronic pelvic pain that is not caused by endometriosis that requires chronic analgesic or other chronic therapy, or that would interfere with the assessment of endometriosis related pain. 4.) Clinically significant gynecological condition identified on Screening transvaginal ultrasound. 5.) Subject has a history of osteoporosis or other metabolic bone disease. 6.) Subject has a current history of undiagnosed abnormal genital bleeding. |
1) Estar embarazada o amamantando o está planificando quedar embarazada en el término de los próximos 24 meses o han transcurrido menos de 6 meses de un parto, de un aborto o de un embarazo al momento del ingreso de la participante en el período de selección. 2) Tener antecedentes de no haber respondido previamente a los agonistas de la GnRH, los antagonistas de la GnRH, el Acetato de medroxiprogesterona de depósito o los inhibidores de la aromatasa, según se evalúa a través del informe de la participante de no haber tenido mejoras en la dismenorrea o el dolor pélvico no menstrual (el informe de la participante de respuesta parcial a estos agentes o de efectos secundarios debidos a ellos no es excluyente). 3) Tener dolor pélvico crónico que no es provocado por endometriosis, que requiere terapia crónica con analgésicos u otra terapia crónica, la cual interferiría en la evaluación del dolor relacionado con endometriosis. 4) Se identifica una afección ginecológica significativa desde el punto de vista clínico en la TVU de la selección. 5) Tener antecedentes de osteoporosis o de otra enfermedad ósea metabólica. 6) La participante tiene antecedentes actuales de sangrado genital anormal sin diagnosticar. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The co-primary efficacy endpoints will be the proportion of responders at Month 3 based upon the mutually-exclusive scales for daily assessments of DYS and NMPP measured by the modified B&B scales using the daily e-Diary |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Secondary efficacy variables will include assessments of the following endpoints at each post-baseline visit: DYS and NMPP, dyspareunia, analgesic use, and other patient-reported outcomes including PGIC, NRS, and EHP-30 |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Monthly, Months 1-6: All secondary efficacy variables above except EHP-30
Months 1, 3 and 6: EHP-30 |
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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 | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
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 | 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 | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 74 |
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 |
Argentina |
Australia |
Austria |
Brazil |
Chile |
Czech Republic |
Hungary |
Italy |
New Zealand |
Poland |
Russian Federation |
South Africa |
Spain |
United Kingdom |
United States |
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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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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 | 6 |
E.8.9.1 | In the Member State concerned days | |
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 | 6 |