stop_circleTerminated/Withdrawn

Endometriosis

Bayer Identifier:

17472

ClinicalTrials.gov Identifier:

NCT03373422

EudraCT Number:

2017-000244-18

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

Female

Age

18 - N/A
  • - Women of at least 18 years of age at the time of signing of informed consent
    - Women with endometriosis confirmed by at least one of the two criteria:
     -- surgery within the last 10 years
     -- imaging within the last 12 months
    - moderate to severe pelvic pain which will be assessed over a period of 28 days
    - Willingness to use only ibuprofen as rescue pain medication for endometriosis-associated pelvic pain
    - Willingness to use non-hormonal barrier method for contraception (here spermicide-coated condoms) from screening visit until the end of the study (unless adequate contraception is achieved by vasectomy of the partner or use of copper intrauterine device [IUD] or commitment to abstinence) and refrain from using hormonal contraception
  • - Pregnancy or lactation (more than three months since delivery, abortion, or lactation before start of treatment) AND no wish for pregnancy during the study
    - Altered bilirubin metabolism and liver function at Visit 1
    - Requirement to use pain medications for reasons other than endometriosis
    - Contraindications to using ibuprofen
    - Signs of hyperandrogenism
    - Absence of menstrual cycles and/or abnormal vaginal/genital bleeding
    - History of hysterectomy, tubal-ligation or bilateral ovariectomy
    - Uncontrolled thyroid disorder

Trial summary

Enrollment Goal
121
Trial Dates
November 2017 - October 2018
Phase
Phase 2
Could I Receive a placebo
Yes
Products
BAY1128688
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Withdrawn
CHU Saint-Pierre/UMC Sint-PieterBRUXELLES - BRUSSEL, 1000, Belgium
Completed
Ziekenhuis Oost-LimburgGENK, 3600, Belgium
Completed
AZ Jan Palfijn GentGent, 9000, Belgium
Completed
Hospital Clínic i Provincial de BarcelonaBarcelona, 08036, Spain
Withdrawn
Hospital Sanitas La ZarzuelaAravaca, 28023, Spain
Completed
Hospital Universitario Virgen del RocíoSevilla, 41013, Spain
Completed
Hospital Regional de MálagaMálaga, 29010, Spain
Completed
Hospital Universitario 12 de OctubreMadrid, 28041, Spain
Completed
Hospital General Universitario de ValenciaValencia, 46014, Spain
Withdrawn
Ciutat Sanitària i Universitaria de la Vall d'HebronBarcelona, 08035, Spain
Completed
Hospital Universitario "La Paz"Madrid, 28046, Spain
Withdrawn
UZ AntwerpenEDEGEM, 2650, Belgium
Completed
CU Saint-Luc/UZ St-LucBRUXELLES - BRUSSEL, 1200, Belgium
Completed
CHU de TivoliLA LOUVIERE, 7100, Belgium
Withdrawn
CHR de la CitadelleLIEGE, 4000, Belgium
Completed
Aarhus Universitetshospital, SkejbyAarhus N, 8200, Denmark
Completed
H:S RigshospitaletKøbenhavn Ø, DK-2100, Denmark
Completed
Allgemeines Krankenhaus der Stadt WienWien, 1090, Austria
Completed
Allgemeines Krankenhaus der Stadt WienWien, 1090, Austria
Completed
Medizinische Universität GrazGraz, 8036, Austria
Completed
Kepler UniversitätsklinikumLinz, 4020, Austria
Withdrawn
Landeskrankenhaus BregenzBregenz, 6900, Austria
Completed
Landeskrankenhaus - Universitätskliniken InnsbruckInnsbruck, 6020, Austria
Completed
NZOZ Zieniewicz MedicalWarszawa, 02-201, Poland
Completed
NZOZ NOVITA, Specjalistyczne Gabinety LekarskieLublin, 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-PolozniczyLublin, 20-064, Poland
Completed
CLINICAL MEDICAL RESEARCH Sp. z o. o.Katowice, 40-001, Poland
Withdrawn
Tomaszewski Medical CenterBialystok, 15-084, Poland
Withdrawn
Pro Creative Poradnia Lekarska S.CKrakow, 31-121, Poland
Completed
VitroLive Sp. z o.o.Szczecin, 70-483, Poland
Completed
Twoja Przychodnia - Szczecinskie Centrum MedyczneSzczecin, 71-434, Poland
Completed
Centrum gynekologicke rehabilitacePisek, 39701, Czech Republic
Completed
Dr. Smrhova-KovacsTabor, 39003, Czech Republic
Withdrawn
Uherskohradistska nemocniceUherske Hradiste, 625 00, Czech Republic
Completed
G-Centrum Olomouc s.r.o. Dr. SkrivanekOlomouc, 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 nemocnicePraha 2, 12821, Czech Republic
Withdrawn
Fakultni Nemocnice OlomoucOlomouc, 779 00, Czech Republic
Completed
GynCare MUDr. Michael Svec s.r.o.Plzen, 326 00, Czech Republic
Completed
Semmelweis UniversityBudapest, 1082, Hungary
Completed
Semmelweis UniversityBudapest, 1085, Hungary
Completed
Debreceni Egyetem Klinikai KozpontDebrecen, 4032, Hungary
Completed
SZTE ÁOK Szent Györgyi Albert Klinikai KozpontSzeged, 6725, Hungary
Completed
Robert Karoly MagankorhazBudapest, 1135, Hungary
Completed
Bajcsy Zsilinszky Korhaz-RendelointezetBudapest, 1106, Hungary
Completed
Fejer Megyei Szent Gyorgy Egyetemi Oktato KorhazSzekesfehervar, 8000, Hungary
Completed
NAP - Rendelo, Private ClinicDebrecen, 4028, Hungary
Completed
Fondazione Policlinico Universitario Agostino GemelliRoma, 00168, Italy
Completed
A.O.U. SeneseSiena, 53100, Italy
Completed
A.O.U. Integrata VeronaVerona, 37126, Italy
Completed
A.S.U. Integrata di UdineUdine, 33100, Italy
Withdrawn
A.R.N.A.S. Civico - Di Cristina - BenfratelliPalermo, 90127, Italy
Completed
A.O.U. di Bologna Policlinico S.Orsola MalpighiBologna, 40138, Italy
Completed
IRCCS A.O.U. San Martino IST Ist. Nazionale Ricerca CancroGenova, 16132, Italy
Completed
Casa di Cura Privata Malzoni - Villa dei PlataniAvellino, 83100, Italy
Withdrawn
John Radcliffe HospitalOxford, OX3 9DU, United Kingdom
Completed
Norfolk and Norwich HospitalNorwich, NR4 7UY, United Kingdom
Completed
York Teaching Hospital NHS Foundation TrustYork, YO318HE, United Kingdom
Withdrawn
St. Antonius ZiekenhuisNieuwegein, 3435 CM, Netherlands
Completed
FlevoziekenhuisALMERE, 1315 RA, Netherlands
Completed
Lääkäriasema Cantti OyKuopio, 70110, Finland
Withdrawn
Tampereen yliopistollinen sairaala, keskussairaalaTampere, 33521, Finland
Completed
HUS / NaistenklinikkaHelsinki, 00290, Finland
Completed
Lääkärikeskus GynekoOulu, 90100, Finland
Completed
Keski-Suomen keskussairaalaJyväskylä, 40620, Finland
Withdrawn
Turun yliopistollinen keskussairaala, kantasairaalaTurku, FIN-20520, Finland
Completed
Cochin - ParisPARIS, 75674, France
Completed
Centre Hospitalier Universitaire - AngersAngers, 49100, France
Withdrawn
Hopital ConceptionMarseille, 13005, France
Withdrawn
Hôpital Jeanne de Flandres - LilleLILLE, 59037, France
Withdrawn
Service de gynecologie obstetrique CHU Clermont FerrandClermont Ferrand, 63000, France
Completed
A.O.U. CareggiFirenze, 50134, Italy
Completed
Praxis Hr. Prof. Dr. A. EbertBerlin, 10787, Germany
Completed
Praxis Hr. Dr. A. GerickAachen, 52072, Germany
Completed
Klinikum rechts der IsarMünchen, 81675, Germany
Withdrawn
Universitätsklinikum Schleswig-Holstein / AÖRLübeck, 23538, Germany
Completed
Praxisklinik am RosengartenMannheim, 68165, Germany
Withdrawn
Universitätsklinikum Giessen und MarburgGießen, 35392, Germany
Completed
Vincentius-Diakonissen-Kliniken gAGKarlsruhe, 76199, Germany
Completed
Praxis f. Gynäkologie und GeburtshilfeBernburg, 06406, Germany
Completed
Charité Campus Benjamin Franklin (CBF)Berlin, 12200, Germany
Completed
Frauenarztpraxis Dr. Wolfgang ClemensStolberg, 52222, Germany
Completed
Praxis Hr. Dr. S. FiedlerAachen, 52074, Germany
Completed
Frauenarztpraxis Dr. WetzelBlankenburg, 38889, Germany
Completed
Whiston HospitalPrescot, L35 5DR, United Kingdom
Completed
IsalaZWOLLE, 8025 AB, Netherlands
Withdrawn
Maasstad ZiekenhuisROTTERDAM, 3079 DZ, Netherlands
Completed
Liverpool Womens HospitalLiverpool, 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 events
    date_rangeTime Frame:
    18 weeks

Trial design

A randomized, placebo-controlled, double-blind, parallel-group, multi-center, exploratory dose-response study to assess the efficacy and safety of different oral doses of BAY1128688 in women with symptomatic endometriosis over a 12-week treatment period
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
N/A
Assignment
Parallel Assignment
Trial Arms
6

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.