stop_circleTerminated/Withdrawn
Endometriosis
Bayer Identifier:
17472
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
A study to test whether study drug BAY1128688 brings pain relief to women with endometriosis and if so to get a first idea which dose(s) work best
Trial purpose
Purpose of the study is to test whether study drug BAY1128688 brings relief for pain to women with endometriosis and if so to get a first impression which dose(s) work best.
Key Participants Requirements
Sex
FemaleAge
18 - N/ATrial summary
Enrollment Goal
121Trial Dates
November 2017 - October 2018Phase
Phase 2Could I Receive a placebo
YesProducts
BAY1128688Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Withdrawn | CHU Saint-Pierre/UMC Sint-Pieter | BRUXELLES - BRUSSEL, 1000, Belgium |
Completed | Ziekenhuis Oost-Limburg | GENK, 3600, Belgium |
Completed | AZ Jan Palfijn Gent | Gent, 9000, Belgium |
Completed | Hospital Clínic i Provincial de Barcelona | Barcelona, 08036, Spain |
Withdrawn | Hospital Sanitas La Zarzuela | Aravaca, 28023, Spain |
Completed | Hospital Universitario Virgen del Rocío | Sevilla, 41013, Spain |
Completed | Hospital Regional de Málaga | Málaga, 29010, Spain |
Completed | Hospital Universitario 12 de Octubre | Madrid, 28041, Spain |
Completed | Hospital General Universitario de Valencia | Valencia, 46014, Spain |
Withdrawn | Ciutat Sanitària i Universitaria de la Vall d'Hebron | Barcelona, 08035, Spain |
Completed | Hospital Universitario "La Paz" | Madrid, 28046, Spain |
Withdrawn | UZ Antwerpen | EDEGEM, 2650, Belgium |
Completed | CU Saint-Luc/UZ St-Luc | BRUXELLES - BRUSSEL, 1200, Belgium |
Completed | CHU de Tivoli | LA LOUVIERE, 7100, Belgium |
Withdrawn | CHR de la Citadelle | LIEGE, 4000, Belgium |
Completed | Aarhus Universitetshospital, Skejby | Aarhus N, 8200, Denmark |
Completed | H:S Rigshospitalet | København Ø, DK-2100, Denmark |
Completed | Allgemeines Krankenhaus der Stadt Wien | Wien, 1090, Austria |
Completed | Allgemeines Krankenhaus der Stadt Wien | Wien, 1090, Austria |
Completed | Medizinische Universität Graz | Graz, 8036, Austria |
Completed | Kepler Universitätsklinikum | Linz, 4020, Austria |
Withdrawn | Landeskrankenhaus Bregenz | Bregenz, 6900, Austria |
Completed | Landeskrankenhaus - Universitätskliniken Innsbruck | Innsbruck, 6020, Austria |
Completed | NZOZ Zieniewicz Medical | Warszawa, 02-201, Poland |
Completed | NZOZ NOVITA, Specjalistyczne Gabinety Lekarskie | Lublin, 20-632, Poland |
Completed | Prywatny Gabinet Lekarski Ginekologia, Poloznictwo i Ultr. | Lodz, 90-602, Poland |
Completed | Vita Longa Sp. z o.o. | Katowice, 40-748, Poland |
Completed | Specjalistyczny Gabinet Ginekologiczno-Polozniczy | Lublin, 20-064, Poland |
Completed | CLINICAL MEDICAL RESEARCH Sp. z o. o. | Katowice, 40-001, Poland |
Withdrawn | Tomaszewski Medical Center | Bialystok, 15-084, Poland |
Withdrawn | Pro Creative Poradnia Lekarska S.C | Krakow, 31-121, Poland |
Completed | VitroLive Sp. z o.o. | Szczecin, 70-483, Poland |
Completed | Twoja Przychodnia - Szczecinskie Centrum Medyczne | Szczecin, 71-434, Poland |
Completed | Centrum gynekologicke rehabilitace | Pisek, 39701, Czech Republic |
Completed | Dr. Smrhova-Kovacs | Tabor, 39003, Czech Republic |
Withdrawn | Uherskohradistska nemocnice | Uherske Hradiste, 625 00, Czech Republic |
Completed | G-Centrum Olomouc s.r.o. Dr. Skrivanek | Olomouc, 772 00, Czech Republic |
Completed | GYN-F s.r.o. | Hradec Kralove, 500 03, Czech Republic |
Withdrawn | GYNEKO spol. s r.o. | Vsetin, 755 01, Czech Republic |
Withdrawn | Vseobecna fakultni nemocnice | Praha 2, 12821, Czech Republic |
Withdrawn | Fakultni Nemocnice Olomouc | Olomouc, 779 00, Czech Republic |
Completed | GynCare MUDr. Michael Svec s.r.o. | Plzen, 326 00, Czech Republic |
Completed | Semmelweis University | Budapest, 1082, Hungary |
Completed | Semmelweis University | Budapest, 1085, Hungary |
Completed | Debreceni Egyetem Klinikai Kozpont | Debrecen, 4032, Hungary |
Completed | SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont | Szeged, 6725, Hungary |
Completed | Robert Karoly Magankorhaz | Budapest, 1135, Hungary |
Completed | Bajcsy Zsilinszky Korhaz-Rendelointezet | Budapest, 1106, Hungary |
Completed | Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz | Szekesfehervar, 8000, Hungary |
Completed | NAP - Rendelo, Private Clinic | Debrecen, 4028, Hungary |
Completed | Fondazione Policlinico Universitario Agostino Gemelli | Roma, 00168, Italy |
Completed | A.O.U. Senese | Siena, 53100, Italy |
Completed | A.O.U. Integrata Verona | Verona, 37126, Italy |
Completed | A.S.U. Integrata di Udine | Udine, 33100, Italy |
Withdrawn | A.R.N.A.S. Civico - Di Cristina - Benfratelli | Palermo, 90127, Italy |
Completed | A.O.U. di Bologna Policlinico S.Orsola Malpighi | Bologna, 40138, Italy |
Completed | IRCCS A.O.U. San Martino IST Ist. Nazionale Ricerca Cancro | Genova, 16132, Italy |
Completed | Casa di Cura Privata Malzoni - Villa dei Platani | Avellino, 83100, Italy |
Withdrawn | John Radcliffe Hospital | Oxford, OX3 9DU, United Kingdom |
Completed | Norfolk and Norwich Hospital | Norwich, NR4 7UY, United Kingdom |
Completed | York Teaching Hospital NHS Foundation Trust | York, YO318HE, United Kingdom |
Withdrawn | St. Antonius Ziekenhuis | Nieuwegein, 3435 CM, Netherlands |
Completed | Flevoziekenhuis | ALMERE, 1315 RA, Netherlands |
Completed | Lääkäriasema Cantti Oy | Kuopio, 70110, Finland |
Withdrawn | Tampereen yliopistollinen sairaala, keskussairaala | Tampere, 33521, Finland |
Completed | HUS / Naistenklinikka | Helsinki, 00290, Finland |
Completed | Lääkärikeskus Gyneko | Oulu, 90100, Finland |
Completed | Keski-Suomen keskussairaala | Jyväskylä, 40620, Finland |
Withdrawn | Turun yliopistollinen keskussairaala, kantasairaala | Turku, FIN-20520, Finland |
Completed | Cochin - Paris | PARIS, 75674, France |
Completed | Centre Hospitalier Universitaire - Angers | Angers, 49100, France |
Withdrawn | Hopital Conception | Marseille, 13005, France |
Withdrawn | Hôpital Jeanne de Flandres - Lille | LILLE, 59037, France |
Withdrawn | Service de gynecologie obstetrique CHU Clermont Ferrand | Clermont Ferrand, 63000, France |
Completed | A.O.U. Careggi | Firenze, 50134, Italy |
Completed | Praxis Hr. Prof. Dr. A. Ebert | Berlin, 10787, Germany |
Completed | Praxis Hr. Dr. A. Gerick | Aachen, 52072, Germany |
Completed | Klinikum rechts der Isar | München, 81675, Germany |
Withdrawn | Universitätsklinikum Schleswig-Holstein / AÖR | Lübeck, 23538, Germany |
Completed | Praxisklinik am Rosengarten | Mannheim, 68165, Germany |
Withdrawn | Universitätsklinikum Giessen und Marburg | Gießen, 35392, Germany |
Completed | Vincentius-Diakonissen-Kliniken gAG | Karlsruhe, 76199, Germany |
Completed | Praxis f. Gynäkologie und Geburtshilfe | Bernburg, 06406, Germany |
Completed | Charité Campus Benjamin Franklin (CBF) | Berlin, 12200, Germany |
Completed | Frauenarztpraxis Dr. Wolfgang Clemens | Stolberg, 52222, Germany |
Completed | Praxis Hr. Dr. S. Fiedler | Aachen, 52074, Germany |
Completed | Frauenarztpraxis Dr. Wetzel | Blankenburg, 38889, Germany |
Completed | Whiston Hospital | Prescot, L35 5DR, United Kingdom |
Completed | Isala | ZWOLLE, 8025 AB, Netherlands |
Withdrawn | Maasstad Ziekenhuis | ROTTERDAM, 3079 DZ, Netherlands |
Completed | Liverpool Womens Hospital | Liverpool, L8 7SS, United Kingdom |
Completed | Gynekologie MEDA s.r.o. | Brno, 602 00, Czech Republic |
Primary Outcome
- Absolute change in mean pain of the 7 days with worst EAPP comparing the 28-day baseline cycle (baseline period of daily pain recordings) to the 28-day end of treatment cycle (daily pain recordings during the last 28 days of the treatment period)EAPP: endometriosis-associated pelvic pain, measured on the NRS (Numerical Rating Scale) by item 1 of the ESD (Endometriosis Symptom Diary)date_rangeTime Frame:12 weeks
Secondary Outcome
- Incidence of treatment-emergent adverse eventsdate_rangeTime Frame:18 weeks
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
N/AAssignment
Parallel AssignmentTrial Arms
6