stop_circleTerminated/Withdrawn
Endometriosis
Bayer Identifier:
15792
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Assess safety and efficacy of vilaprisan in subjects with endometriosis
Trial purpose
The primary objective of this study was to assess the efficacy and safety of two doses of vilaprisan compared to placebo in women with symptomatic endometriosis.
The secondary objective of this study was to evaluate the safety and tolerability of two different doses of vilaprisan in women with symptomatic endometriosis.
With the implementation of protocol version 4.0 dated 11-Dec-2018, no new subjects were enrolled. The objectives above cannot be reached as only limited data is available from subjects recruited before the temporary pause.
The secondary objective of this study was to evaluate the safety and tolerability of two different doses of vilaprisan in women with symptomatic endometriosis.
With the implementation of protocol version 4.0 dated 11-Dec-2018, no new subjects were enrolled. The objectives above cannot be reached as only limited data is available from subjects recruited before the temporary pause.
Key Participants Requirements
Sex
FemaleAge
18 YearsTrial summary
Enrollment Goal
8Trial Dates
July 2018 - November 2020Phase
Phase 2Could I Receive a placebo
YesProducts
Vilaprisan (BAY1002670)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Withdrawn | Instituto Chileno de Medicina Reproductiva | Santiago, Chile |
Withdrawn | Insituto de Investigaciones Materno Infantil | Santiago, 8360160, Chile |
Withdrawn | Hospital Regional de Concepción "Guillermo Grant Benavente" | Concepción, 4070038, Chile |
Withdrawn | GTC Research | Shawnee, 66218, United States |
Completed | Office of Dr. James A. Simon, MD | Washington, 20036, United States |
Withdrawn | Yale University School of Medicine | New Haven, 06511, United States |
Withdrawn | Centex Studies, Inc. | Houston, 77058, United States |
Withdrawn | Wake Forest Baptist Health | Clemmons, 27103, United States |
Withdrawn | A.O.U. Careggi | Firenze, 50134, Italy |
Withdrawn | Robert Wood Johnson University Hospital | New Brunswick, 08901, United States |
Withdrawn | Hospital of the University of Pennsylvania | Philadelpahia, 19104, United States |
Completed | Unified Women's Clinical Research - Morehead City | Morehead City, 28557, United States |
Withdrawn | Augusta University Medical Center | Augusta, 30912, United States |
Completed | Ottawa Hospital-Riverside Campus | Ottawa, K1H 7W9, Canada |
Completed | Clinique OVO | Montreal, H4P 2S4, Canada |
Withdrawn | ALPHA Recherche Clinique | Quebec, G3K 2P8, Canada |
Withdrawn | Bosque Womens Care | Albuquerque, 87109, United States |
Withdrawn | DCC Aleksandrovska | Sofia, 1606, Bulgaria |
Withdrawn | SHATOG Maichin dom EAD | Sofia, 1431, Bulgaria |
Withdrawn | MHAT for Women's Health - Nadezhda OOD | Sofia, 1330, Bulgaria |
Withdrawn | Artemis Institute for Clinical Research | San Diego, 92103, United States |
Withdrawn | Willowbend Health & Wellness Associates | Frisco, 75035, United States |
Withdrawn | Unified Women’s Clinical Research | Greensboro, 27408, United States |
Withdrawn | Fusion Clinical Research of Spartanburg, LLC | Spartanburg, 29301, United States |
Withdrawn | Omni Fertility and Laser Institute | Shreveport, 71118, United States |
Withdrawn | VitaLink Research - Greenville | Greenville, 29615, United States |
Withdrawn | Columbus OB-GYN/Radiant Research | Columbus, 43213, United States |
Withdrawn | SC Clinical Research, Inc | Garden Grove, 92844, United States |
Withdrawn | Medical Center for Clinical Research | San Diego, 92108, United States |
Withdrawn | ClinSearch, LLC | Chattanooga, 37421, United States |
Withdrawn | Florida Research Center, Inc. | Miami, 33174, United States |
Withdrawn | Clearview Medical Research, LLC | Canyon Country, 91351, United States |
Withdrawn | Advanced Clinical Research | Salt Lake City, 84107, United States |
Withdrawn | NECCR Primacare Research | Fall River, 02720, United States |
Withdrawn | Avail Clinical Research, LLC | DeLand, 32720, United States |
Withdrawn | The Woman's Hospital of Texas | Houston, 77054, United States |
Withdrawn | CHI Health Creighton University Medical Center | Omaha, 68130, United States |
Withdrawn | Ideal Clinical Research | Aventura, 33180, United States |
Completed | Universitätsklinikum AKH Wien | Wien, 1090, Austria |
Completed | Universitätsklinikum AKH Wien | Wien, 1090, Austria |
Completed | Medizinische Universität Graz | Graz, 8036, Austria |
Completed | Kepler Universitätsklinikum Campus IV | Linz, 4020, Austria |
Withdrawn | Landeskrankenhaus Feldkirch | Feldkirch, 6807, Austria |
Withdrawn | Hospital Clínic i Provincial de Barcelona | Barcelona, 08036, Spain |
Withdrawn | MHAT Avis Medika | Pleven, 5800, Bulgaria |
Withdrawn | Center of Reproductive Medicine | Webster, 77598, United States |
Withdrawn | Advanced Gynecologic Surgical Institute | Park Ridge, 60068, United States |
Withdrawn | Carolina Women's Research & Wellness Center | Durham, 27713, United States |
Withdrawn | Wake Research, Inc. | Raleigh, 27612, United States |
Withdrawn | Karolinska Universitetssjukhuset | Stockholm, 171 76, Sweden |
Withdrawn | Södersjukhuset AB | Stockholm, 118 83, Sweden |
Withdrawn | Danderyds sjukhus | Stockholm, 182 88, Sweden |
Withdrawn | Akademiska Sjukhuset | Uppsala, 751 85, Sweden |
Completed | KABEG Landeskrankenhaus Villach | Villach, 9500, Austria |
Withdrawn | Hôpital Cantonal Universitaire de Genève | Genève, 1205, Switzerland |
Withdrawn | UniversitätsSpital Zürich | Zürich, 8091, Switzerland |
Withdrawn | Luzerner Kantonsspital | Luzern, 6000, Switzerland |
Withdrawn | Aarhus Universitetshospital, Skejby | Aarhus N, 8200, Denmark |
Withdrawn | Rigshospitalet | Copenhagen, 2100, Denmark |
Withdrawn | Universitätsspital Basel | Basel, 4031, Switzerland |
Withdrawn | Clinical Trials of South Carolina | Charleston, 29406, United States |
Completed | Solutions Through Advanced Research, Inc. | Jacksonville, 32256, United States |
Withdrawn | Hospital Universitario Quirón de Madrid | Pozuelo de Alarcón, 28223, Spain |
Withdrawn | Hospital de la Santa Creu i de Sant Pau | Barcelona, 08025, Spain |
Completed | Queen's University | Kingston, K7L 2V7, Canada |
Withdrawn | The First Hospital of Jilin University | Changchun, 130000, China |
Withdrawn | Shanghai First Maternity and Infant Hospital | Shanghai, 201204, China |
Withdrawn | The First Affiliated Hospital of Dalian Medical University | Dalian, 116011, China |
Withdrawn | Shengjing Hospital of China Medical University | Shenyang, 110004, China |
Withdrawn | Wuhan Tongji Reproductive Medicine Hospital | Wuhan, 430013, China |
Withdrawn | Women's Hospital School of Medicine Zhejiang University | Hangzhou, 310006, China |
Withdrawn | Vincentius-Diakonissen-Kliniken gAG | Karlsruhe, 76199, Germany |
Withdrawn | Charité Campus Benjamin Franklin (CBF) | Berlin, 12200, Germany |
Withdrawn | Praxis f. Gynäkologie und Geburtshilfe | Bernburg, 06406, Germany |
Withdrawn | IACT Health | Columbus, 31904, United States |
Withdrawn | Diagnostic Clinic of Longview | Longview, 75605, United States |
Withdrawn | Alliance for Multispecialty Research, LLC | Fort Myers, 33912, United States |
Withdrawn | Heinrich-Heine-Universität Düsseldorf | Düsseldorf, 40225, Germany |
Withdrawn | Städtisches Klinikum Karlsruhe gGmbH | Karlsruhe, 76133, Germany |
Withdrawn | St. Elisabeth Gruppe GmbH | Herne, 44649, Germany |
Withdrawn | Frauenärzte am Schloss Borbeck | Essen, 45355, Germany |
Withdrawn | Frauenärzte am Staden | Saarbrücken, 66121, Germany |
Withdrawn | Hospital de Basurto | Bilbao, 48013, Spain |
Withdrawn | Hospital Universitario de Álava - Sede Txagorritxu | Vitoria, 01009, Spain |
Withdrawn | CHUC - Hospitais da Universidade de Coimbra | Coimbra, 3000-075, Portugal |
Withdrawn | Hospital de Braga | Braga, 4710-243, Portugal |
Withdrawn | Hospital da Luz - Lisboa | Lisboa, 1500-650, Portugal |
Withdrawn | CHLO - Hospital Sao Francisco Xavier | Lisboa, 1449-005, Portugal |
Withdrawn | Hospital Garcia de Orta | Almada, 2801-951, Portugal |
Completed | VL-Medi Oy | Helsinki, 00510, Finland |
Completed | Satakunnan keskussairaala | Pori, 28500, Finland |
Withdrawn | Seinäjoen keskussairaala | Seinäjoki, FIN 60220, Finland |
Withdrawn | M & O Clinical Research, LLC | Ft. Lauderdale, 33316, United States |
Withdrawn | Women’s Center for Pelvic Health | Charlotte, 28207, United States |
Completed | A.O.U.I. Verona | Verona, 37126, Italy |
Withdrawn | A.O.U. di Bologna Policlinico S.Orsola Malpighi | Bologna, 40138, Italy |
Withdrawn | A.O.U. Policlinico Umberto I | Roma, Italy |
Withdrawn | Ospedale San Raffaele s.r.l. | Milano, 20132, Italy |
Withdrawn | Gynekologie Studentsky dum s.r.o. | Praha 6, 160 00, Czechia |
Withdrawn | Precision Clinical Research, LLC | Coral Springs, 33065, United States |
Withdrawn | Eastern Virginia Medical School | Norfolk, 23507, United States |
Completed | Unified Women's Clinical Research | Winston-Salem, 27103, United States |
Withdrawn | Unified Women's Clinical Research | Raleigh, 27607, United States |
Withdrawn | Harbor - UCLA Medical Center | Torrance, 90509-2910, United States |
Withdrawn | Stamford Hospital | Stamford, 06904, United States |
Withdrawn | Clinical Trial Network | Houston, 77021, United States |
Completed | Southern Clinical Research Associates LLC | Metairie, 70001, United States |
Completed | Helix Biomedics, LLC | Boynton Beach, 33435, United States |
Withdrawn | University Hospitals Landerbrook Health Center | Mayfield Heights, 44124, United States |
Withdrawn | Omega Research Orlando | Orlando, 32808, United States |
Withdrawn | Pecsi Tudomanyegyetem Klinikai Kozpont | Pecs, 7624, Hungary |
Withdrawn | Tritonlife Robert Magankorhaz | Budapest, 1135, Hungary |
Withdrawn | MH Egeszsegugyi Kozpont | Budapest, 1062, Hungary |
Withdrawn | Genium Egeszsegugyi, Csaladtervezesi es Diag. Kozpont | Budapest, 1146, Hungary |
Withdrawn | Oviedo Medical Research, LLC | Oviedo, 32765, United States |
Withdrawn | GynPorCentrum s.r.o. | Krnov, 794 01, Czechia |
Completed | GynCare MUDr. Michael Svec s.r.o. | Plzen, 326 00, Czechia |
Completed | Gynekologie MEDA s.r.o. | Brno, 602 00, Czechia |
Withdrawn | GYNEVI s.r.o. | Rokycany, 337 01, Czechia |
Withdrawn | MUDr. Martina Maresova Rosenbergova, gynekologie | Plzen, 300 01, Czechia |
Withdrawn | CUORE s.r.o. | Praha 6, 160 00, Czechia |
Withdrawn | Vitalink Research - Spartanburg | Spartenburg, 29303, United States |
Withdrawn | Eastern Research | Hialeah, 33013, United States |
Withdrawn | University of Alabama at Birmingham | Birmingham, 35294-0026, United States |
Withdrawn | Olympia Clinical Trials | Los Angeles, 90036, United States |
Withdrawn | Seven Hills Women's Health Centers | Cincinnati, 45242, United States |
Withdrawn | A Premier Medical Research of Florida, LLC | Orange City, 32763, United States |
Withdrawn | Centrum Medyczne Angelius Provita | Katowice, 40-611, Poland |
Withdrawn | TERPA Sp. z o.o. Sp. k. | Lublin, 20-333, Poland |
Withdrawn | NZOZ "Medis" Specjalistyczne Gabinety Ginekologiczne | Lublin, 20-411, Poland |
Withdrawn | CENTRUM MEDYCZNE ZELAZNA Szpital i Przychodnia Sw. Zofii | Warszawa, 01-004, Poland |
Completed | Centrum Medyczne Chodzki | Lublin, 20-093, Poland |
Withdrawn | Centrum Ginekologii Endokrynologii i Medycyny Rozrodu ARTEMI | Bialystok, 15-464, Poland |
Withdrawn | Seattle Clinical Research Center | Seattle, 98105, United States |
Withdrawn | Debreceni Egyetem Klinikai Kozpont | Debrecen, 4032, Hungary |
Withdrawn | NAP - Rendelo, Private Clinic | Debrecen, 4028, Hungary |
Withdrawn | SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont | Szeged, 6725, Hungary |
Withdrawn | Invictus Clinical Research Group, LLC | Miami, 33144, United States |
Withdrawn | Clinova Clinical Trials | Spring, 77379, United States |
Withdrawn | Femi MED Maganrendelo | Budapest, 1075, Hungary |
Withdrawn | Johns Hopkins University School of Medicine | Baltimore, 21287, United States |
Withdrawn | Meir Medical Center | Kfar Saba, 4428164, Israel |
Withdrawn | Hillel Yaffe Medical Center | Hadera, 3810101, Israel |
Withdrawn | Clalit Health Services through HaEmek Medical Center | Afula, 1834111, Israel |
Withdrawn | Health Corporation of Galilee Medical Center | Nahariya, 2210001, Israel |
Withdrawn | Lady Davis Carmel Medical Center | Haifa, 3436212, Israel |
Withdrawn | California Center for Clinical Research | Arcadia, 91007, United States |
Withdrawn | International Peace Maternity&Child Health Hospital of CWI | Shanghai, 200030, China |
Withdrawn | Shanghai General Hospital | Shanghai, 200080, China |
Withdrawn | Zhongda Hospital Southeast University | Nanjing, 210009, China |
Withdrawn | The Second Affiliated Hospital Zhejiang University School o | Hangzhou, 310051, China |
Withdrawn | Shanghai East Hospital Affiated to Tongji University | Shanghai, 200123, China |
Withdrawn | NJ Drum Tower Hospital, the Affil Hos of NJ Univ Med School | Nanjing, 210008, China |
Withdrawn | West China Second University Hospital | Chengdu, 610066, China |
Withdrawn | The First Affiliated Hospital of Xinjiang Medical University | Urumqi, 830054, China |
Withdrawn | SichuanAcademyofMedicalSciences&SichuanProvincialPeople'sHos | Chengdu, 610072, China |
Withdrawn | Kurashiki Medical Clinic | Kurashiki, 710-0824, Japan |
Completed | Tokeidai Memorial Clinic | Sapporo, 060-0031, Japan |
Completed | Ishikawa Prefectural Central Hospital | Kanazawa, 920-8530, Japan |
Withdrawn | Nagano Municipal Hospital | Nagano, 381-8551, Japan |
Withdrawn | Jusendo Geneal Hospital Yuasa Foundation | Koriyama, 963-8585, Japan |
Withdrawn | Hamanomachi Hospital | Fukuoka, 810-8539, Japan |
Withdrawn | Kobe City Nishi-Kobe Medical Center | Kobe, 651-2273, Japan |
Completed | Japanese Red Cross Kumamoto Hospital | Kumamoto, 861-8520, Japan |
Completed | Toyama Prefectural Central Hospital | Toyama, 930-8550, Japan |
Withdrawn | Japanese Red Cross Kyoto Daini Hospital | Kyoto, 602-8026, Japan |
Withdrawn | The 3rd Affiliated Hospital of Guangzhou Medical University | Guangzhou, 510150, China |
Withdrawn | Zhongshan People's Hospital | Zhongshan, 528403, China |
Withdrawn | Boai Hospital of Zhongshan | Zhongshan, China |
Withdrawn | National Taiwan University Hospital | Taipei, 100, Taiwan |
Withdrawn | Taichung Veterans General Hospital | Taichung, 40705, Taiwan |
Withdrawn | National Cheng Kung University Hospital | Tainan, 704, Taiwan |
Withdrawn | Mackay Memorial Hospital | Taipei, 10449, Taiwan |
Withdrawn | Hospital Son Llatzer | Palma, 07198, Spain |
Withdrawn | Hospital Universitario "La Paz" | Madrid, 28016, Spain |
Withdrawn | Ms Ladies Clinic | Sapporo, 060-0807, Japan |
Withdrawn | Teine Keijinkai Hospital | Sapporo, 006-8555, Japan |
Withdrawn | Asahi clinic | Takamatsu, 760-0076, Japan |
Withdrawn | Medizinische Universität Innsbruck | Innsbruck, 6020, Austria |
Withdrawn | Great Lakes Research Group, Inc. | Saginaw, 48602, United States |
Withdrawn | Signature GYN Services, Pllc | Fort Worth, 76104-4145, United States |
Withdrawn | Hamada Hospital | Chiyoda-ku, 101-0062, Japan |
Withdrawn | Yokohama City Minato Red Cross Hospital | Yokohama, 231-8682, Japan |
Withdrawn | Sanin Rosai Hospital | Yonago, 683-8605, Japan |
Withdrawn | Aventiv Research - Columbus | Columbus, 43213, United States |
Withdrawn | Aso Iizuka Hospital | Iizuka, 820-8505, Japan |
Withdrawn | OMI MEDICAL CENTER | Kusatsu, 525-8585, Japan |
Withdrawn | Research Alliance, Inc. | Melbourne, 32901, United States |
Withdrawn | JOHAS Yokohama Rosai Hospital | Yokohama, 222-0036, Japan |
Withdrawn | Tokyo Women's Medical University Hospital | Shinjuku-ku, 162-8666, Japan |
Withdrawn | Precision Trials, AZ, LLC | Phoenix, 85032, United States |
Withdrawn | Denver Infertility Albrecht Women’s Care | Englewood, 80112, United States |
Withdrawn | Daping Hospital, 3rd Affil Hosp. 3rd Military Med Univ PLA | Chongqing, 400042, China |
Withdrawn | The Second Affiliated Hospital of Nanjing Medical university | Nanjing, 210011, China |
Withdrawn | Compass Research, LLC | Orlando, 32806, United States |
Withdrawn | Tidewater Clinical Research, Inc. | Norfolk, 23456, United States |
Withdrawn | Lanzhou University Second Hospital | Lanzhou, 730030, China |
Withdrawn | Palmetto Clinical Research | Summerville, 29485, United States |
Withdrawn | The First Affiliated Hospital of Sun Yat-Sen University | Guangzhou, 510080, China |
Withdrawn | First Affiliated Hospital of Guangzhou Medical University | Guangzhou, 510120, China |
Withdrawn | Hospital General Universitario de Valencia | Valencia, 46014, Spain |
Withdrawn | Beijing Tsinghua Changgung Hospital | Beijing, 102218, China |
Withdrawn | Penn State Milton S. Hershey Medical Center | Hershey, 17033-0850, United States |
Withdrawn | Atlanta Gynecology Research Institute | Peachtree Corners, 30092, United States |
Withdrawn | Praxis Hr. Dr. S. Fiedler | Aachen, 52074, Germany |
Withdrawn | Inselspital Universitätsspital Bern | Bern, 3010, Switzerland |
Withdrawn | West Coast OB/GYN Associates | San Diego, 92123, United States |
Primary Outcome
- Mean worst pelvic pain (measured on a numerical rating scale [NRS], recorded in the daily endometriosis symptom diary [ESD])Pain intensity was assessed on 11-point (0-10) NRS by ESD item 1. In ESD item 1, participants were asked to rate the worst pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. Mean ‘worst pelvic pain’ was calculated as the sum of the participant’s daily assessments of the ESD item 1 (“worst pain” during the last 24 hours) during a study period divided by number of days with pain assessment in that study period. This was summarized by study period. No inferential statistical analysis was performed.date_rangeTime Frame:Screening period (up to a maximum of 75 days) + treatment period (up to a maximum of 168 days)
Secondary Outcome
- Mean worst pelvic pain (measured on a numerical rating scale [NRS], recorded in the daily endometriosis symptom diary [ESD]) on days with/without vaginal bleedingPain intensity was assessed on 11-point (0-10) NRS by ESD item 1. In ESD item 1, participants were asked to rate the worst pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. Mean ‘worst pelvic pain’ on bleeding/non-bleeding days was calculated as the sum of the participant’s daily assessments of the ESD item 1 (“worst pain” during the last 24 hours) on bleedings/non-bleeding days during a study period divided by number of bleeding/non-bleeding days with pain assessment in that study period. This was summarized by study period. No inferential statistical analysis was performed.date_rangeTime Frame:Screening period (up to a maximum of 75 days) + treatment period (up to a maximum of 168 days)
- Mean number of tablets of rescue pain medication 1 (Ibuprofen 200 mg) taken daily for Endometriosis-associated pelvic pain (EAPP)Mean number of tablets of rescue pain medication 1 (Ibuprofen 200 mg) taken daily for EAPP was calculated as the sum of the tablets taken for EAPP during a study period divided by the number of days in that study period. This was summarized by study period. No inferential statistical analysis was performed.date_rangeTime Frame:Screening period (up to a maximum of 75 days) + treatment period (up to a maximum of 168 days)
- Mean number of tablets of rescue pain medication 2 (Tramadol 50 mg) taken daily for Endometriosis-associated pelvic pain (EAPP)Mean number of tablets of rescue pain medication 2 (Tramadol 50 mg) taken daily for EAPP was calculated as the sum of the tablets taken for EAPP during a study period divided by the number of days in that study period. This was summarized by study period. No inferential statistical analysis was performed.date_rangeTime Frame:Screening period (up to a maximum of 75 days) + treatment period (up to a maximum of 168 days)
- The number of participants with treatment emergent adverse events (TEAEs)date_rangeTime Frame:Up to 6 months
- Number of participants with clinical significant abnormal endometrial histology findingsdate_rangeTime Frame:Up to 6 months
- Number of participants with clinical significant abnormal ultrasound examinationsdate_rangeTime Frame:Up to 6 months
- Number of participants with clinical significant abnormal bone mineral density measurementsdate_rangeTime Frame:Up to 6 months
- Number of participants with clinical significant abnormal laboratory valuesdate_rangeTime Frame:Up to 6 months
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
N/AAssignment
Parallel AssignmentTrial Arms
3