stop_circleTerminated/Withdrawn

Endometriosis

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.

Key Participants Requirements

Sex

Female

Age

18 Years
  • - Signed and dated informed consent
    - Pre-menopausal women 18 years (inclusive) and above at the time of Visit 1
    - Women with endometriosis confirmed by laparoscopy or laparotomy OR diagnosed based on imaging
    - Moderate to severe endometriosis-associated pelvic pain (EAPP)
    - Adherence to screening period diary entries
    - Willingness to use only standardized pain medication if needed
    - Good general health (except for findings related to endometriosis)
    - Normal or clinically insignificant cervical cytology not requiring further follow-up
    - An endometrial biopsy performed at the screening phase without significant histological disorder
    - Use of an acceptable non-hormonal method of contraception
    - Willingness / ability to comply with electronic diary entry for the duration of study participation
  • - Pregnancy or lactation (less than 3 months since delivery, abortion, or lactation before Visit 1)
    - Hypersensitivity to any ingredient of the study treatments
    - Laboratory values outside the inclusion range before randomization, and considered clinically relevant
    - 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 elevated liver enzymes
    - Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results
    - Undiagnosed abnormal genital bleeding
    - Abuse of alcohol, drugs, or medicines (e.g. laxatives) as evaluated by the investigator
    - Use of other treatments that might interfere with the conduct of the study or the interpretation of the results
    - Endometriosis-specific treatments for symptom relief except rescue pain medication according to protocol
    - 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
    - Inability to cooperate with the study procedures for any reason
    - 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)
    - Hypersensitivity to any ingredient of standardized pain medication
    - Wish for pregnancy during the study
    - Regular use of pain medication due to other underlying diseases
    - Non-responsiveness of EAPP to GnRH-a (Gonadotropin-releasing hormone agonists)

Trial summary

Enrollment Goal
8
Trial Dates
July 2018 - November 2020
Phase
Phase 2
Could I Receive a placebo
Yes
Products
Vilaprisan (BAY1002670)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Withdrawn
Instituto Chileno de Medicina ReproductivaSantiago, Chile
Withdrawn
Insituto de Investigaciones Materno InfantilSantiago, 8360160, Chile
Withdrawn
Hospital Regional de Concepción "Guillermo Grant Benavente"Concepción, 4070038, Chile
Withdrawn
GTC ResearchShawnee, 66218, United States
Completed
Office of Dr. James A. Simon, MDWashington, 20036, United States
Withdrawn
Yale University School of MedicineNew Haven, 06511, United States
Withdrawn
Centex Studies, Inc.Houston, 77058, United States
Withdrawn
Wake Forest Baptist HealthClemmons, 27103, United States
Withdrawn
A.O.U. CareggiFirenze, 50134, Italy
Withdrawn
Robert Wood Johnson University HospitalNew Brunswick, 08901, United States
Withdrawn
Hospital of the University of PennsylvaniaPhiladelpahia, 19104, United States
Completed
Unified Women's Clinical Research - Morehead CityMorehead City, 28557, United States
Withdrawn
Augusta University Medical CenterAugusta, 30912, United States
Completed
Ottawa Hospital-Riverside CampusOttawa, K1H 7W9, Canada
Completed
Clinique OVOMontreal, H4P 2S4, Canada
Withdrawn
ALPHA Recherche CliniqueQuebec, G3K 2P8, Canada
Withdrawn
Bosque Womens CareAlbuquerque, 87109, United States
Withdrawn
DCC AleksandrovskaSofia, 1606, Bulgaria
Withdrawn
SHATOG Maichin dom EADSofia, 1431, Bulgaria
Withdrawn
MHAT for Women's Health - Nadezhda OODSofia, 1330, Bulgaria
Withdrawn
Artemis Institute for Clinical ResearchSan Diego, 92103, United States
Withdrawn
Willowbend Health & Wellness AssociatesFrisco, 75035, United States
Withdrawn
Unified Women’s Clinical ResearchGreensboro, 27408, United States
Withdrawn
Fusion Clinical Research of Spartanburg, LLCSpartanburg, 29301, United States
Withdrawn
Omni Fertility and Laser InstituteShreveport, 71118, United States
Withdrawn
VitaLink Research - GreenvilleGreenville, 29615, United States
Withdrawn
Columbus OB-GYN/Radiant ResearchColumbus, 43213, United States
Withdrawn
SC Clinical Research, IncGarden Grove, 92844, United States
Withdrawn
Medical Center for Clinical ResearchSan Diego, 92108, United States
Withdrawn
ClinSearch, LLCChattanooga, 37421, United States
Withdrawn
Florida Research Center, Inc.Miami, 33174, United States
Withdrawn
Clearview Medical Research, LLCCanyon Country, 91351, United States
Withdrawn
Advanced Clinical ResearchSalt Lake City, 84107, United States
Withdrawn
NECCR Primacare ResearchFall River, 02720, United States
Withdrawn
Avail Clinical Research, LLCDeLand, 32720, United States
Withdrawn
The Woman's Hospital of TexasHouston, 77054, United States
Withdrawn
CHI Health Creighton University Medical CenterOmaha, 68130, United States
Withdrawn
Ideal Clinical ResearchAventura, 33180, United States
Completed
Universitätsklinikum AKH WienWien, 1090, Austria
Completed
Universitätsklinikum AKH WienWien, 1090, Austria
Completed
Medizinische Universität GrazGraz, 8036, Austria
Completed
Kepler Universitätsklinikum Campus IVLinz, 4020, Austria
Withdrawn
Landeskrankenhaus FeldkirchFeldkirch, 6807, Austria
Withdrawn
Hospital Clínic i Provincial de BarcelonaBarcelona, 08036, Spain
Withdrawn
MHAT Avis MedikaPleven, 5800, Bulgaria
Withdrawn
Center of Reproductive MedicineWebster, 77598, United States
Withdrawn
Advanced Gynecologic Surgical InstitutePark Ridge, 60068, United States
Withdrawn
Carolina Women's Research & Wellness CenterDurham, 27713, United States
Withdrawn
Wake Research, Inc.Raleigh, 27612, United States
Withdrawn
Karolinska UniversitetssjukhusetStockholm, 171 76, Sweden
Withdrawn
Södersjukhuset ABStockholm, 118 83, Sweden
Withdrawn
Danderyds sjukhusStockholm, 182 88, Sweden
Withdrawn
Akademiska SjukhusetUppsala, 751 85, Sweden
Completed
KABEG Landeskrankenhaus VillachVillach, 9500, Austria
Withdrawn
Hôpital Cantonal Universitaire de GenèveGenève, 1205, Switzerland
Withdrawn
UniversitätsSpital ZürichZürich, 8091, Switzerland
Withdrawn
Luzerner KantonsspitalLuzern, 6000, Switzerland
Withdrawn
Aarhus Universitetshospital, SkejbyAarhus N, 8200, Denmark
Withdrawn
RigshospitaletCopenhagen, 2100, Denmark
Withdrawn
Universitätsspital BaselBasel, 4031, Switzerland
Withdrawn
Clinical Trials of South CarolinaCharleston, 29406, United States
Completed
Solutions Through Advanced Research, Inc.Jacksonville, 32256, United States
Withdrawn
Hospital Universitario Quirón de MadridPozuelo de Alarcón, 28223, Spain
Withdrawn
Hospital de la Santa Creu i de Sant PauBarcelona, 08025, Spain
Completed
Queen's UniversityKingston, K7L 2V7, Canada
Withdrawn
The First Hospital of Jilin UniversityChangchun, 130000, China
Withdrawn
Shanghai First Maternity and Infant HospitalShanghai, 201204, China
Withdrawn
The First Affiliated Hospital of Dalian Medical UniversityDalian, 116011, China
Withdrawn
Shengjing Hospital of China Medical UniversityShenyang, 110004, China
Withdrawn
Wuhan Tongji Reproductive Medicine HospitalWuhan, 430013, China
Withdrawn
Women's Hospital School of Medicine Zhejiang UniversityHangzhou, 310006, China
Withdrawn
Vincentius-Diakonissen-Kliniken gAGKarlsruhe, 76199, Germany
Withdrawn
Charité Campus Benjamin Franklin (CBF)Berlin, 12200, Germany
Withdrawn
Praxis f. Gynäkologie und GeburtshilfeBernburg, 06406, Germany
Withdrawn
IACT HealthColumbus, 31904, United States
Withdrawn
Diagnostic Clinic of LongviewLongview, 75605, United States
Withdrawn
Alliance for Multispecialty Research, LLCFort Myers, 33912, United States
Withdrawn
Heinrich-Heine-Universität DüsseldorfDüsseldorf, 40225, Germany
Withdrawn
Städtisches Klinikum Karlsruhe gGmbHKarlsruhe, 76133, Germany
Withdrawn
St. Elisabeth Gruppe GmbHHerne, 44649, Germany
Withdrawn
Frauenärzte am Schloss BorbeckEssen, 45355, Germany
Withdrawn
Frauenärzte am StadenSaarbrücken, 66121, Germany
Withdrawn
Hospital de BasurtoBilbao, 48013, Spain
Withdrawn
Hospital Universitario de Álava - Sede TxagorritxuVitoria, 01009, Spain
Withdrawn
CHUC - Hospitais da Universidade de CoimbraCoimbra, 3000-075, Portugal
Withdrawn
Hospital de BragaBraga, 4710-243, Portugal
Withdrawn
Hospital da Luz - LisboaLisboa, 1500-650, Portugal
Withdrawn
CHLO - Hospital Sao Francisco XavierLisboa, 1449-005, Portugal
Withdrawn
Hospital Garcia de OrtaAlmada, 2801-951, Portugal
Completed
VL-Medi OyHelsinki, 00510, Finland
Completed
Satakunnan keskussairaalaPori, 28500, Finland
Withdrawn
Seinäjoen keskussairaalaSeinäjoki, FIN 60220, Finland
Withdrawn
M & O Clinical Research, LLCFt. Lauderdale, 33316, United States
Withdrawn
Women’s Center for Pelvic HealthCharlotte, 28207, United States
Completed
A.O.U.I. VeronaVerona, 37126, Italy
Withdrawn
A.O.U. di Bologna Policlinico S.Orsola MalpighiBologna, 40138, Italy
Withdrawn
A.O.U. Policlinico Umberto IRoma, 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, LLCCoral Springs, 33065, United States
Withdrawn
Eastern Virginia Medical SchoolNorfolk, 23507, United States
Completed
Unified Women's Clinical ResearchWinston-Salem, 27103, United States
Withdrawn
Unified Women's Clinical ResearchRaleigh, 27607, United States
Withdrawn
Harbor - UCLA Medical CenterTorrance, 90509-2910, United States
Withdrawn
Stamford HospitalStamford, 06904, United States
Withdrawn
Clinical Trial NetworkHouston, 77021, United States
Completed
Southern Clinical Research Associates LLCMetairie, 70001, United States
Completed
Helix Biomedics, LLCBoynton Beach, 33435, United States
Withdrawn
University Hospitals Landerbrook Health CenterMayfield Heights, 44124, United States
Withdrawn
Omega Research OrlandoOrlando, 32808, United States
Withdrawn
Pecsi Tudomanyegyetem Klinikai KozpontPecs, 7624, Hungary
Withdrawn
Tritonlife Robert MagankorhazBudapest, 1135, Hungary
Withdrawn
MH Egeszsegugyi KozpontBudapest, 1062, Hungary
Withdrawn
Genium Egeszsegugyi, Csaladtervezesi es Diag. KozpontBudapest, 1146, Hungary
Withdrawn
Oviedo Medical Research, LLCOviedo, 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, gynekologiePlzen, 300 01, Czechia
Withdrawn
CUORE s.r.o.Praha 6, 160 00, Czechia
Withdrawn
Vitalink Research - SpartanburgSpartenburg, 29303, United States
Withdrawn
Eastern ResearchHialeah, 33013, United States
Withdrawn
University of Alabama at BirminghamBirmingham, 35294-0026, United States
Withdrawn
Olympia Clinical TrialsLos Angeles, 90036, United States
Withdrawn
Seven Hills Women's Health CentersCincinnati, 45242, United States
Withdrawn
A Premier Medical Research of Florida, LLCOrange City, 32763, United States
Withdrawn
Centrum Medyczne Angelius ProvitaKatowice, 40-611, Poland
Withdrawn
TERPA Sp. z o.o. Sp. k.Lublin, 20-333, Poland
Withdrawn
NZOZ "Medis" Specjalistyczne Gabinety GinekologiczneLublin, 20-411, Poland
Withdrawn
CENTRUM MEDYCZNE ZELAZNA Szpital i Przychodnia Sw. ZofiiWarszawa, 01-004, Poland
Completed
Centrum Medyczne ChodzkiLublin, 20-093, Poland
Withdrawn
Centrum Ginekologii Endokrynologii i Medycyny Rozrodu ARTEMIBialystok, 15-464, Poland
Withdrawn
Seattle Clinical Research CenterSeattle, 98105, United States
Withdrawn
Debreceni Egyetem Klinikai KozpontDebrecen, 4032, Hungary
Withdrawn
NAP - Rendelo, Private ClinicDebrecen, 4028, Hungary
Withdrawn
SZTE ÁOK Szent Györgyi Albert Klinikai KozpontSzeged, 6725, Hungary
Withdrawn
Invictus Clinical Research Group, LLCMiami, 33144, United States
Withdrawn
Clinova Clinical TrialsSpring, 77379, United States
Withdrawn
Femi MED MaganrendeloBudapest, 1075, Hungary
Withdrawn
Johns Hopkins University School of MedicineBaltimore, 21287, United States
Withdrawn
Meir Medical CenterKfar Saba, 4428164, Israel
Withdrawn
Hillel Yaffe Medical CenterHadera, 3810101, Israel
Withdrawn
Clalit Health Services through HaEmek Medical CenterAfula, 1834111, Israel
Withdrawn
Health Corporation of Galilee Medical CenterNahariya, 2210001, Israel
Withdrawn
Lady Davis Carmel Medical CenterHaifa, 3436212, Israel
Withdrawn
California Center for Clinical ResearchArcadia, 91007, United States
Withdrawn
International Peace Maternity&Child Health Hospital of CWIShanghai, 200030, China
Withdrawn
Shanghai General HospitalShanghai, 200080, China
Withdrawn
Zhongda Hospital Southeast UniversityNanjing, 210009, China
Withdrawn
The Second Affiliated Hospital Zhejiang University School oHangzhou, 310051, China
Withdrawn
Shanghai East Hospital Affiated to Tongji UniversityShanghai, 200123, China
Withdrawn
NJ Drum Tower Hospital, the Affil Hos of NJ Univ Med SchoolNanjing, 210008, China
Withdrawn
West China Second University HospitalChengdu, 610066, China
Withdrawn
The First Affiliated Hospital of Xinjiang Medical UniversityUrumqi, 830054, China
Withdrawn
SichuanAcademyofMedicalSciences&SichuanProvincialPeople'sHosChengdu, 610072, China
Withdrawn
Kurashiki Medical ClinicKurashiki, 710-0824, Japan
Completed
Tokeidai Memorial ClinicSapporo, 060-0031, Japan
Completed
Ishikawa Prefectural Central HospitalKanazawa, 920-8530, Japan
Withdrawn
Nagano Municipal HospitalNagano, 381-8551, Japan
Withdrawn
Jusendo Geneal Hospital Yuasa FoundationKoriyama, 963-8585, Japan
Withdrawn
Hamanomachi HospitalFukuoka, 810-8539, Japan
Withdrawn
Kobe City Nishi-Kobe Medical CenterKobe, 651-2273, Japan
Completed
Japanese Red Cross Kumamoto HospitalKumamoto, 861-8520, Japan
Completed
Toyama Prefectural Central HospitalToyama, 930-8550, Japan
Withdrawn
Japanese Red Cross Kyoto Daini HospitalKyoto, 602-8026, Japan
Withdrawn
The 3rd Affiliated Hospital of Guangzhou Medical UniversityGuangzhou, 510150, China
Withdrawn
Zhongshan People's HospitalZhongshan, 528403, China
Withdrawn
Boai Hospital of ZhongshanZhongshan, China
Withdrawn
National Taiwan University HospitalTaipei, 100, Taiwan
Withdrawn
Taichung Veterans General HospitalTaichung, 40705, Taiwan
Withdrawn
National Cheng Kung University HospitalTainan, 704, Taiwan
Withdrawn
Mackay Memorial HospitalTaipei, 10449, Taiwan
Withdrawn
Hospital Son LlatzerPalma, 07198, Spain
Withdrawn
Hospital Universitario "La Paz"Madrid, 28016, Spain
Withdrawn
Ms Ladies ClinicSapporo, 060-0807, Japan
Withdrawn
Teine Keijinkai HospitalSapporo, 006-8555, Japan
Withdrawn
Asahi clinicTakamatsu, 760-0076, Japan
Withdrawn
Medizinische Universität InnsbruckInnsbruck, 6020, Austria
Withdrawn
Great Lakes Research Group, Inc.Saginaw, 48602, United States
Withdrawn
Signature GYN Services, PllcFort Worth, 76104-4145, United States
Withdrawn
Hamada HospitalChiyoda-ku, 101-0062, Japan
Withdrawn
Yokohama City Minato Red Cross HospitalYokohama, 231-8682, Japan
Withdrawn
Sanin Rosai HospitalYonago, 683-8605, Japan
Withdrawn
Aventiv Research - ColumbusColumbus, 43213, United States
Withdrawn
Aso Iizuka HospitalIizuka, 820-8505, Japan
Withdrawn
OMI MEDICAL CENTERKusatsu, 525-8585, Japan
Withdrawn
Research Alliance, Inc.Melbourne, 32901, United States
Withdrawn
JOHAS Yokohama Rosai HospitalYokohama, 222-0036, Japan
Withdrawn
Tokyo Women's Medical University HospitalShinjuku-ku, 162-8666, Japan
Withdrawn
Precision Trials, AZ, LLCPhoenix, 85032, United States
Withdrawn
Denver Infertility Albrecht Women’s CareEnglewood, 80112, United States
Withdrawn
Daping Hospital, 3rd Affil Hosp. 3rd Military Med Univ PLAChongqing, 400042, China
Withdrawn
The Second Affiliated Hospital of Nanjing Medical universityNanjing, 210011, China
Withdrawn
Compass Research, LLCOrlando, 32806, United States
Withdrawn
Tidewater Clinical Research, Inc.Norfolk, 23456, United States
Withdrawn
Lanzhou University Second HospitalLanzhou, 730030, China
Withdrawn
Palmetto Clinical ResearchSummerville, 29485, United States
Withdrawn
The First Affiliated Hospital of Sun Yat-Sen UniversityGuangzhou, 510080, China
Withdrawn
First Affiliated Hospital of Guangzhou Medical UniversityGuangzhou, 510120, China
Withdrawn
Hospital General Universitario de ValenciaValencia, 46014, Spain
Withdrawn
Beijing Tsinghua Changgung HospitalBeijing, 102218, China
Withdrawn
Penn State Milton S. Hershey Medical CenterHershey, 17033-0850, United States
Withdrawn
Atlanta Gynecology Research InstitutePeachtree Corners, 30092, United States
Withdrawn
Praxis Hr. Dr. S. FiedlerAachen, 52074, Germany
Withdrawn
Inselspital Universitätsspital BernBern, 3010, Switzerland
Withdrawn
West Coast OB/GYN AssociatesSan 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 bleeding
    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’ 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 findings
    date_rangeTime Frame:
    Up to 6 months
  • Number of participants with clinical significant abnormal ultrasound examinations
    date_rangeTime Frame:
    Up to 6 months
  • Number of participants with clinical significant abnormal bone mineral density measurements
    date_rangeTime Frame:
    Up to 6 months
  • Number of participants with clinical significant abnormal laboratory values
    date_rangeTime Frame:
    Up to 6 months

Trial design

A randomized, double-blind, parallel-group, multicenter Phase 2b study to assess the efficacy and safety of two different doses of vilaprisan (BAY1002670) versus placebo in women with symptomatic endometriosis
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
N/A
Assignment
Parallel Assignment
Trial Arms
3