stop_circleTerminated/Withdrawn

Endometriosis

Study to gather information how well three different doses of BAY1817080 given twice daily over 12 weeks work in comparison to an inactive pill (placebo) and elagolix in women suffering from pain related to a condition where the tissue that usually grows inside the womb grows outside of the womb

Trial purpose

The purpose of this study is to assess safety and efficacy of BAY 1817080 compared to elagolix and placebo in women with symptomatic endometriosis. Study details include:
- Study duration: 155 up to 285 days
- Treatment duration: 84 days
- Visit frequency: 3 laboratory every 2 weeks for participants on BAY 1817080 or placebo

Key Participants Requirements

Sex

Female

Age

18 - N/A
  • - Participant must be ≥ 18 years of age at the time of signing the informed consent
    - Visually-confirmed endometriosis: detection of endometriotic lesions during laparoscopy or laparotomy (with or without pathological diagnosis) within 10 years but no less than 8 weeks from Visit 1a (surgically diagnosed endometriosis). For Japan only and limited to no more than half of all randomized Japanese participants: the diagnosis can be based on previous imaging (i.e. endometriosis lesion detected by ultrasound or MRI). If the participant was diagnosed by ultrasound, the lesion must be visualized again by ultrasound at the screening visit. If the participant was diagnosed by MRI, the diagnosis must have been made within 12 months before Visit 1a (clinically diagnosed endometriosis).
    - Both sub-criteria regarding pain symptoms must be fulfilled:
     -- At Visit 1a, participant presents self-reported moderate to severe pain which – based on the judgement of the investigator – carries a reasonable likelihood to translate into a severity of pain symptoms sufficient to fulfil the eligibility criterion and be caused by endometriosis, and
     -- During the screening period at least 24 daily ESD entries during the 28 consecutive days starting on the first day with menstrual bleeding at or after Visit 1a and entries in the ESD item 1a (‘worst pain’ on the daily numerical rating scale) sum up to 98 or more.
    - Willingness to use standardized rescue pain medications for EAPP (i.e. ibuprofen, acetaminophen and tramadol) and not use any prophylactic pain medication, according to investigator’s instruction
    - Ability to swallow the study intervention, i.e., the different kinds of tablets, as complete units
    - Good general health (except for findings related to endometriosis) as proven by medical history, physical and gynecological examinations and laboratory test results
    - Normal or clinically insignificant cervical cytology not requiring further follow-up:
     -- A cervical cytology sample has to be obtained during screening, or
     -- A documented normal result has to be available from cervical cytology conducted within 12 months prior to Visit 1a.
     -- Human papilloma virus (HPV) testing in participants with atypical squamous cells of unknown significance (ASCUS) will be used as an adjunctive test automatically. Participants with ASCUS can be included if they are negative for high-risk HPV strains.
  • - Current pregnancy or less than 3 months since delivery, abortion or stop of lactation before Visit 1a
    - Hypersensitivity to any ingredient of the study intervention and/or the standardized rescue medications
    - Known osteoporosis
    - History of a low trauma fracture
    - Contraindications for elagolix or the standardized rescue medications
    - Current malignancy or history of cancer (exception: basal cell or squamous cell carcinoma of the skin) within the last 5 years prior to Visit 1a
    - Any other diseases or conditions that according to the investigator can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study intervention (e.g. extremely low body weight, chronic bowel disease, Crohn's disease and ulcerative colitis)
    - Menopause or signs of menopausal transition, such as absence of regular menstrual cycles based on investigator’s judgment (absence of information regarding menstrual bleeding pattern e.g. due to long term use of hormonal contraception is not an exclusion criterion)
    - Any disease or condition that may worsen during the study period according to the assessment and opinion of the investigator
    - Abnormal uterine bleeding in terms of regularity or heaviness (with the exception of heavy menstrual bleeding that does not require treatment)
    - Any findings that require further diagnostic procedures to avoid harm to the participant (e.g. ovarian tumors of uncertain origin or pelvic masses of unclear etiology)
    - Any serious or unstable diseases or medical conditions, including psychiatric disorders, that might interfere with the conduct of the study or the interpretation of the result, including for example:
     -- history of hysterectomy and/or bilateral oophorectomy
     -- any conditions considered to contribute significantly to pelvic pain by the investigator, e.g. fibromyalgia, uterine fibroids, irritable bowel syndrome or other bowel disorders
     -- any other underlying diseases requiring regular use of pain medication (e.g. migraine)
     -- history of or current anxiety or depression unless stable with or without medical treatment ≥ 6 months before Visit 1a
    - Major surgery scheduled during the study period
    - Non-responsiveness of EAPP to earlier treatment with GnRH-agonists or GnRH-antagonists, based on the judgement of the investigator
    - SARS-CoV-2- positive virus RNA test within 4 weeks prior to Visit 1a reported by participant, regardless of whether the participant had symptoms
    - History of COVID-19 infection with persistent/ongoing symptoms
    - Contact with SARS-CoV-2- positive or COVID-19 patient within the last 4 weeks prior to Visit 1a
    - Intake of medication prohibited due to potential drug-drug interaction
    - Use of other treatments that might interfere with the conduct of the study or the interpretation of the results, including:
     -- hormonal medications
     -- other treatments intended for endometriosis/pelvic pain during participation in the study, including the use of herbal products or traditional Chinese medicine for symptom relief, with the exception of the standardized rescue pain medications
    - Simultaneous participation in another clinical trial with investigational medicinal product(s). Participation in another trial 3 months prior to Visit 1a that might have an impact on the study objectives, at the discretion of the investigator
    - Previous assignment to study intervention (randomization) in this study (allowing previously randomized participants to be re-included into the study may lead to bias)
    - Laboratory values outside the inclusion range (specified in the laboratory manual) and considered clinically relevant

Trial summary

Enrollment Goal
215
Trial Dates
January 2021 - May 2022
Phase
Phase 2
Could I Receive a placebo
Yes
Products
Eliapixant (BAY1817080)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Oslo Universitetssykehus HF, UllevålOslo, 450, Norway
Completed
Kirkeparken SpesialistpraksisFredrikstad, 1605, Norway
Withdrawn
Stavanger UHospital CardiologyStavanger, 4011, Norway
Completed
ULMUS, s r.o.Hlohovec, 920 01, Slovakia
Completed
A.O.U.I. VeronaVerona, 37134, Italy
Completed
Fondazione IRCCS Ca' Granda Ospedale Maggiore PoliclinicoMilano, 20122, Italy
Completed
A.O.U. CareggiFirenze, 50134, Italy
Completed
IRCCS Ospedale Policlinico San MartinoGenova, 16132, Italy
Completed
Fondazione Policlinico Universitario Agostino Gemelli IRCCSRoma, 00168, Italy
Completed
Ospedale San Raffaele s.r.l.Milano, 20132, Italy
Completed
ASST Sette LaghiVarese, 21049, Italy
Completed
A.O.U. di Bologna Policlinico S.Orsola MalpighiBologna, 40138, Italy
Completed
Universitätsklinikum AKH WienWien, 1090, Austria
Completed
Universitätsklinikum AKH WienWien, 1090, Austria
Completed
Medizinische Universität GrazGraz, 8036, Austria
Completed
Fakultni nemocnice BrnoBrno, 625 00, Czech Republic
Completed
Gynekologie Meda s.r.o. - LidickaBrno - stred, 60200, Czech Republic
Completed
Fakultní nemocnice BulovkaPraha 8, 180 81, Czech Republic
Completed
Dr. Smrhova-KovacsTabor, 39003, Czech Republic
Completed
G-Centrum Olomouc s.r.o. Dr. SkrivanekCeske Budejovice, 370 01, Czech Republic
Completed
GynCare MUDr. Michael Svec s.r.o.Plzen, 326 00, Czech Republic
Completed
GYN-MIKA s.r.o.Ceske Budejovice, 370 01, Czech Republic
Completed
Gynekologie Studentsky dum s.r.o.Praha 6, 160 00, Czech Republic
Completed
Centrum gynekologicke rehabilitacePísek, 397 01, Czech Republic
Completed
GYNERAPraha 5, 156 00, Czech Republic
Completed
GA Lucenec s.r.oLucenec, 984 01, Slovakia
Completed
BrenCare, s.r.o.Poprad, 058 01, Slovakia
Completed
Virina sano, s.r.o. Gynekologicko porodnicka ambulanciaVelky Krtis, 990 01, Slovakia
Completed
GYN-FIV a.s.Bratislava, 821 01, Slovakia
Not yet recruiting
Hospital Clínic i Provincial de BarcelonaBarcelona, 8036, Spain
Not yet recruiting
Hospital Clinico San Carlos | Women´s Health InstituteMadrid, 28040, Spain
Completed
H Santa Creu i Sant Pau|GineBarcelona, 8041, Spain
Completed
Hospital Universitario 12 de OctubreMadrid, 28041, Spain
Not yet recruiting
Complejo Hospitalario de NavarraPamplona, 31008, Spain
Not yet recruiting
Hospital Universitario La Paz | IdiPAZ - Neurology DepartmentMadrid, 28046, Spain
Not yet recruiting
H Virgen del Rocio |Cardiology|AF|Stroke preventionSevilla, 41013, Spain
Completed
Hospital de BasurtoBilbao, 48013, Spain
Completed
Hospital General Universitario de ValenciaValencia, 46014, Spain
Completed
NZOZ NOVITA, Specjalistyczne Gabinety Lekarskie S.CLublin, 20-632, Poland
Completed
Specjalistyczny Gabinet Ginekologiczno-PolozniczyLublin, 20-400, Poland
Completed
CLINICAL MEDICAL RESEARCH Sp. z o. o.Katowice, 40-156, Poland
Completed
Vita Longa Sp. z o.o.Katowice, 40-748, Poland
Completed
Centrum Badawcze Wspolczesnej TerapiiWarszawa, 02-679, Poland
Completed
Nasz Lekarz Przychodnie Medyczne Slawomir JekaTorun, 87-100, Poland
Completed
Gabinet Ginekologiczny Janusz TomaszewskiBialystok, 15-224, Poland
Completed
NZOZ MEDEM Wilk Sp. j.Katowice, 40-301, Poland
Completed
MTZ Clinical Research Sp z o.o.Warszawa, 02-106, Poland
Completed
Prywatny Gabinet Lekarski Ginekologia, Poloznictwo i Ultr.Lodz, 90-602, Poland
Completed
VitroLive Sp. z o.o.Szczecin, 70-483, Poland
Completed
Medical Concierge Centrum MedyczneWarszawa, 02-798, Poland
Completed
Clinic EliteTartu, 50407, Estonia
Completed
Parnu HospitalParnu, 80010, Estonia
Completed
East Tallinn Central HospitalTallinn, 10138, Estonia
Not yet recruiting
Hospital Universitario de Álava - Sede TxagorritxuVitoria, 1009, Spain
Completed
The Ottawa Hospital | The Ottawa Hospital Research Institute - Neurology - Ottawa Stroke ProgramOttawa, K1Y4E9, Canada
Completed
Clinique Ovo | R&D DepartmentMontreal, H4P 2S4, Canada
Not yet recruiting
KINGSTON HEALTH SCIENCES CENTREKingston, K7L 2V7, Canada
Completed
Alpha Recherche Clinique | LebourgneufQuebec, G2J 0C4, Canada
Completed
JSC Seimos gydytojas family medical centerVilnius, LT-01118, Lithuania
Withdrawn
Private hospital and outpatient clinic "Kardiolita"Vilnius, LT-05263, Lithuania
Completed
JSC Gyvenk Silciau Medical Center MaxmedaVilnius, LT-03225, Lithuania
Completed
Multiprofile Hospital for Active Treatment Niamed OOD | Department of Obstetrics and GynecologyStara Zagora, 6000, Bulgaria
Completed
Medical Centre Asklepii OOD | Dupnitsa, BulgariaDupnitza, 2600, Bulgaria
Completed
Medical Center Panacea OOD | Sofia, BulgariaSofia, 1606, Bulgaria
Completed
Specialized Hospital for Active Treatment of Oncological Diseases Sofia Region | Oncological Gynecology DepartmentSofia, 1233, Bulgaria
Completed
Praxis f. Gynäkologie und GeburtshilfeBernburg, 6406, Germany
Completed
Praxisklinik am RosengartenMannheim, 68165, Germany
Completed
Charité - Campus Virchow-Klinikum (CVK)Berlin, 13353, Germany
Completed
emovis GmbHBerlin, 10629, Germany
Completed
Universitätsklinikum HeidelbergHeidelberg, 69115, Germany
Completed
Vincentius-Diakonissen-Kliniken gAGKarlsruhe, 76199, Germany
Completed
HUS / NaistenklinikkaHelsinki, 29, Finland
Completed
Seinäjoen keskussairaalaSeinäjoki, 60220, Finland
Completed
Lapin keskussairaalaRovaniemi, 96100, Finland
Withdrawn
Riga East Clinical University Hospital "Gailezers"Riga, LV-1038, Latvia
Completed
I.Vasaraudzes Private PracticeRiga, LV-1011, Latvia
Completed
Vitols and Vitols LtdRiga, LV-1006, Latvia
Completed
AZ Jan Palfijn GentGent, 9000, Belgium
Withdrawn
Matules and Melkas gynecology private clinicRiga, LV-1011, Latvia
Completed
Social Medical Corporation Tokeidai Memorial HospitalSapporo, 060-0031, Japan
Completed
Teine Keijinkai HospitalSapporo, 006-8555, Japan
Completed
Nishikawa Women's Health ClinicSapporo, 060-0061, Japan
Completed
Aiiku Ladies ClinicFunabashi, 274-0071, Japan
Completed
Tokyo Bay Urayasu Ichikawa Medical CenterUrayasu, 279-0001, Japan
Completed
NTT Medical Center TokyoShinagawa-ku, 141-8625, Japan
Completed
Fujisawa City HospitalFujisawa, 251-8550, Japan
Completed
Kashiwazaki ladies clinicSaitama, 330-0855, Japan
Completed
Ibaraki Prefectural Central HospitalKasama, 309-1793, Japan
Completed
Hitachi General HospitalHitachi, 317-0077, Japan
Completed
Toyama Rosai HospitalUozu, 937-0042, Japan
Completed
OMI MEDICAL CENTERKusatsu, 525-8585, Japan
Completed
Suita Tokushukai HospitalSuita, 565-0814, Japan
Completed
Kurashiki Medical ClinicKurashiki, 710-0824, Japan
Completed
JCHO Tokuyama Central HospitalShunan, 745-8522, Japan
Completed
Saiseikai Nagasaki HospitalNagasaki, 850-0003, Japan
Completed
CU Saint-Luc/UZ St-LucBRUXELLES - BRUSSEL, 1200, Belgium
Completed
Ziekenhuis Oost-Limburg | Genk, Sint-Jan campus - Cardiology DepartmentGenk, 3600, Belgium
Not yet recruiting
UZ Leuven GasthuisbergLEUVEN, 3000, Belgium
Completed
UZ GentGENT, 9000, Belgium
Completed
NAP-MED Egeszsegugyi Szolgaltato KftDebrecen, 4028, Hungary
Completed
Pecsi Tudomanyegyetem Klinikai KozpontPecs, 7623, Hungary
Withdrawn
Magyar Honvedseg Egeszsegugyi KozpontBudapest, 1062, Hungary
Completed
Debreceni Egyetem Klinikai KozpontDebrecen, 4032, Hungary
Completed
Cortex Study CenterBudapest, 1026, Hungary
Completed
Obudai Egeszsegugyi CentrumBudapest, 1036, Hungary
Completed
Peking University First HospitalBeijing, 100034, China
Withdrawn
Shanghai East Hospital Affiated to Tongji Universityshanghai, 200100, China
Not yet recruiting
The First Affiliated Hospital of Xi'an Jiaotong UniversityXi'an, 710061, China
Completed
Wuhan Tongji Reproductive Medicine HospitalWuhan, 430013, China
Completed
First Affiliated Hospital of Guangzhou Medical UniversityGuangzhou, 510120, China
Completed
Guangzhou Women and Children's Medical CenterGuangzhou, 510623, China
Not yet recruiting
The 2nd Hospital of Hebei Medical UniversityShijiazhuang, 50000, China
Completed
Women's Hospital School of Medicine Zhejiang UniversityHangzhou, 310006, China
Not yet recruiting
The Second Affliated Hospital of Wenzhou Medicial UniversityWenzhou, 325000, China
Not yet recruiting
SichuanAcademyofMedicalSciences&SichuanProvincialPeople'sHosChengdu, 610072, China
Not yet recruiting
The First Affiliated Hospital of Guangzhou University of TCMGuangzhou, 510405, China
Withdrawn
West China Second University HospitalChengdu, 610041, China
Not yet recruiting
Chengdu Women & Children's Central HospitalChengdu, 610091, China
Withdrawn
Zhongda Hospital Southeast UniversityNanjing, 210009, China
Completed
The Second Affiliated Hospital of Nanjing Medical universitynanjing, 210000, China
Completed
Paramount Research Solutions | College Park LocationCollege Park, 30349, United States
Completed
University of Alabama at BirminghamBirmingham, 35233, United States
Completed
Southern Clinical Research Associates | Metairie, LAMetairie, 70001, United States
Withdrawn
Unified Women’s Clinical ResearchGreensboro, 27408, United States
Completed
A Premier Medical Research of Florida, LLCOrange City, 32763, United States
Withdrawn
University of Illinois at Chicago | Department of NeurologyChicago, 60612, United States
Completed
Eastern Virginia Medical School | OB/GYN Clinical Research CenterNorfolk, 23507, United States
Completed
Centricity Research formerly Aventiv - DublinDublin, 43016, United States
Completed
Willowbend Health and Wellness AssociatesPlano, 75093, United States
Completed
SunCoast Clinical Research Palm HarborPalm Harbor, 34684, United States
Completed
Journey Medical ResearchSnellville, 30078, United States
Completed
Carolina Women's Research & Wellness CenterDurham, 27713, United States
Completed
Seattle Women's | Seattle, WASeattle, 98105, United States
Completed
Clinical Inquest Center, Ltd.Beavercreek, 45432, United States
Completed
Women's Health AllianceRaleigh, 27607, United States
Completed
UTHealth Womens Research Program | Memorial CityHouston, 77054, United States
Completed
University Hospitals | UH Cleveland Medical Center - MacDonald Clinical Trials UnitMayfield Heights, 44124, United States
Completed
SUNY Downstate Medical CenterBrooklyn, 11203, United States
Completed
Chattanooga Medical Research, LLC. | Chattanooga, TNChattanooga, 37404, United States
Completed
Medisense Inc. | Atlanta, GAAtlanta, 30363, United States
Completed
Virginia Physicians For WomenNorth Chesterfield, 23235, United States
Completed
Continental Clinical Solutions | Towson, MDTowson, 21204, United States
Completed
Helix Biomedics LLC | Boynton Beach, FLBoynton Beach, 33435, United States
Completed
Diagnamics | Encinitas, CAEncinitas, 92024, United States
Completed
Lyndhurst Clinical ResearchWinston-Salem, 27103, United States
Completed
Advanced Women's Health Institute | Denver Office, Greenwood Village, COParker, 80134, United States
Completed
Mobile ObGyn, P.C. | Mobile, ALMobile, 36608-6703, United States
Completed
Advances in HealthPearland, 77584, United States
Completed
Wayne State University Physicians GroupDetroit, 48201, United States
Completed
Women's Medical Research Group, LLCClearwater, 33759, United States
Withdrawn
John Hopkins Outpatient CenterBaltimore, 21287, United States
Completed
Biopharma Informatic, Inc.Houston, 77043, United States
Withdrawn
Sekine, Rasner & Brock and Associates, MD, LLCJacksonville, 32223, United States
Completed
IntimMedicine | Washington, DCWashington, 20036, United States
Completed
Suncoast Clinical Research Inc. | PascoTrinity, 34655, United States
Withdrawn
Medical University of South Carolina | MUSC Center for Womens Health - Department of Obstetrics and GynecologyCharleston, 29425, United States
Completed
Bosque Women's Care | Albuquerque, NMAlbuquerque, 87109, United States
Completed
Physician Care Clinical Research LLC | Sarasota, FLSarasota, 34239, United States
Completed
Houston Center for Clinical Research | Sugar Land, TXSugarland, 77479, United States
Completed
Medical Center for Clinical ResearchSan Diego, 92108, United States
Completed
HWC Women's Research Center | Englewood, OHEnglewood, 45322, United States
Completed
Atlanta Women's Research Institute, Inc. - AtlantaAtlanta, 30342, United States
Completed
Augusta University Medical CenterAugusta, 30912, United States
Withdrawn
Robert Wood Johnson University HospitalNew Brunswick, 08901, United States
Completed
Paramount Research Solutions-NashvilleNashville, 37203, United States
Completed
Medical Research Center of Memphis | Memphis, TNMemphis, 38120, United States
Completed
Palmetto Clinical ResearchSummerville, 29485, United States
Completed
Yokosuka Kyosai HospitalYokosuka, 238-8558, Japan
Completed
Japanese Red Cross Kumamoto HospitalKumamoto, 861-8520, Japan
Completed
ARETAIEION University HospitalAthens, 11528, Greece
Completed
ELENA VENIZELOU HospitalAthens, 115 21, Greece
Completed
General Hospital of Thessaloniki PapageorgiouThessaloniki, 56403, Greece
Completed
University General Hospital of Patras | Univ Obs & Gynae CliPatra, 26504, Greece
Completed
V. Jonaitienes private gynecology clinicVilnius, LT-01123, Lithuania
Completed
ClinSearch, LLCHixson, 37421, United States
Completed
International Clinical Research-Tennessee LLC.Murfreesboro, 37130, United States
Completed
Clinical Trials Management, LLC - MetairieMetairie, 70006, United States
Withdrawn
Clinical Trials of Texas, Inc.San Antonio, 78229, United States
Completed
Centex Studies, Inc.Lake Charles, 70601, United States
Completed
Alliance for Multispecialty Research, LLC. | Fort Myers, FLFort Myers, 33912, United States
Withdrawn
Jersey Shore University Medical CenterNeptune, 7753, United States
Withdrawn
Comprehensive Clinical TrialsWest Palm Beach, 33409, United States
Completed
Accel Research Sites | Cahaba Medical Care - Birmingham, ALBirmingham, 35218, United States
Completed
Discovery Clinical Trials - DallasDallas, 75231, United States
Completed
West Coast OB/GYN AssociatesSan Diego, 92123, United States
Completed
SZTE ÁOK Szent Györgyi Albert Klinikai KozpontSzeged, 6720, Hungary
Completed
I.Dinsbergas Physician PracticeRiga, LV-1013, Latvia
Completed
Nagasaki University HospitalNagasaki, 852-8501, Japan
Completed
Centex Studies, Inc.Lake Charles, 70601, United States
Completed
Tidewater Clinical Research, Inc.Norfolk, 23456, United States
Completed
Olympia Clinical TrialsLos Angeles, 90036, United States
Completed
Clinical Research PrimeIdaho Falls, 83404, United States
Completed
Precision Trials, AZ, LLCPhoenix, 85032, United States
Not yet recruiting
The Second Hospital of Jilin UniversityChangchun, 130000, China
Completed
Sykehuset i Vestfold HF, TønsbergTønsberg, 3116, Norway
Withdrawn
Sir Run Run Shaw Hospital, Zhejiang Univ. School of MedicineHangzhou, 310016, China
Completed
Essential Women’s Health AssociatesLas Vegas, 89113, United States
Completed
Latvian Maritime Medicine CenterRiga, LV-1005, Latvia
Withdrawn
Signature GYN Services, PllcFort Worth, 76104-4145, United States
Withdrawn
The Second Affiliated Hospital of Shanxi Medical UniversityTaiyuan, 30001, China
Completed
Beijing Obstetrics and Gynecology Hospital,Capital Med.Uni.Beijing, 100026, China
Completed
1st Riga Clinical HospitalRiga, LV-1001, Latvia
Completed
Lääkärikeskus Gyneko, Gynaecological Medical Center | Oulu, FinlandOulu, 90100, Finland
Completed
Sou ClinicYotsukaido, 284-0001, Japan
Completed
SBAGAL Dr. Dimitar Stamatov | Varna, BulgariaVarna, 9000, Bulgaria
Withdrawn
Praxis Hr. Dr. S. FiedlerAachen, 52074, Germany
Completed
Rub-Int Noi EgeszsegcentrumSzekesfehervar, 8000, Hungary
Withdrawn
Medplus NordrheinKrefeld, 47799, Germany
Completed
Oslo Universitetssykehus HF, UllevålOslo, 0450, Norway
Completed
Kirkeparken SpesialistpraksisFredrikstad, 1605, Norway
Withdrawn
Stavanger UniversitetssjukehusStavanger, 4011, Norway
Completed
ULMUS, s r.o.Hlohovec, 920 01, Slovakia
Completed
A.O.U.I. VeronaVerona, 37126, Italy
Completed
Fondazione IRCCS Ca' Granda Ospedale Maggiore PoliclinicoMilano, 20122, Italy
Completed
A.O.U. CareggiFirenze, 50134, Italy
Completed
IRCCS Ospedale Policlinico San MartinoGenova, 16132, Italy
Completed
Fondazione Policlinico Universitario Agostino Gemelli IRCCSRoma, 00168, Italy
Withdrawn
Ospedale San Raffaele s.r.l.Milano, 20132, Italy
Completed
ASST Sette LaghiVarese, 21100, Italy
Withdrawn
A.O.U. di Bologna Policlinico S.Orsola MalpighiBologna, 40138, Italy
Completed
Universitätsklinikum AKH WienWien, 1090, Austria
Completed
Universitätsklinikum AKH WienWien, 1090, Austria
Completed
Medizinische Universität GrazGraz, 8036, Austria
Completed
Fakultni nemocnice BrnoBrno, 625 00, Czechia
Completed
Gynekologie Meda s.r.o. - LidickaBrno - stred, 60200, Czechia
Completed
Fakultní nemocnice BulovkaPraha 8, 180 81, Czechia
Completed
Dr. Smrhova-KovacsTabor, 39003, Czechia
Withdrawn
G-Centrum Olomouc s.r.o. Dr. SkrivanekOlomouc, 772 00, Czechia
Completed
GynCare MUDr. Michael Svec s.r.o.Plzen, 326 00, Czechia
Completed
GYN-MIKA s.r.o.Ceske Budejovice, 370 01, Czechia
Completed
Gynekologie Studentsky dum s.r.o.Praha 6, 160 00, Czechia
Completed
Centrum gynekologicke rehabilitacePisek, 39701, Czechia
Completed
GYNERAPraha 5, 156 00, Czechia
Completed
GA Lucenec s.r.oLucenec, 984 01, Slovakia
Withdrawn
BrenCare, s.r.o.Poprad, 058 01, Slovakia
Completed
Virina sano, s.r.o. Gynekologicko porodnicka ambulanciaVelky Krtis, 990 01, Slovakia
Withdrawn
GYN-FIV a.s.Bratislava, 821 01, Slovakia
Withdrawn
Hospital Clínic i Provincial de BarcelonaBarcelona, 08036, Spain
Withdrawn
Hospital Clínico Universitario San CarlosMadrid, 28040, Spain
Completed
Hospital de la Santa Creu i de Sant Pau | GinecologiaBarcelona, 08041, Spain
Completed
Hospital Universitario 12 de OctubreMadrid, 28041, Spain
Withdrawn
Complejo Hospitalario de NavarraPamplona, 31008, Spain
Withdrawn
Hospital Universitario "La Paz"Madrid, 28046, Spain
Withdrawn
Hospital Universitario Virgen del RocíoSevilla, 41013, Spain
Completed
Hospital de BasurtoBilbao, 48013, Spain
Completed
Hospital General Universitario de ValenciaValencia, 46014, Spain
Completed
NZOZ NOVITA, Specjalistyczne Gabinety Lekarskie S.CLublin, 20-632, Poland
Completed
Specjalistyczny Gabinet Ginekologiczno-PolozniczyLublin, 20-400, Poland
Completed
CLINICAL MEDICAL RESEARCH Sp. z o. o.Katowice, 40-156, Poland
Completed
Vita Longa Sp. z o.o.Katowice, 40-748, Poland
Withdrawn
Centrum Badawcze Wspolczesnej TerapiiWarszawa, 02-679, Poland
Completed
MICS Centrum Medyczne TorunBydgoszcz, 85-065, Poland
Completed
Gabinet Ginekologiczny Janusz TomaszewskiBialystok, 15-244, Poland
Completed
NZOZ MEDEM Wilk Sp. j.Katowice, 40-301, Poland
Completed
MTZ Clinical Research Sp z o.o.Warszawa, 02-106, Poland
Completed
Prywatny Gabinet Lekarski Ginekologia, Poloznictwo i Ultr.Lodz, 90-602, Poland
Completed
VitroLive Sp. z o.o.Szczecin, 70-483, Poland
Completed
Medical Concierge Centrum MedyczneWarszawa, 02-798, Poland
Completed
Clinic EliteTartu, 50407, Estonia
Completed
Parnu HospitalParnu, 80010, Estonia
Withdrawn
East Tallinn Central HospitalTallinn, 10138, Estonia
Withdrawn
Hospital Universitario de Álava - Sede TxagorritxuVitoria, 01009, Spain
Completed
The Ottawa HospitalOttawa, K1H 7W9, Canada
Completed
Clinique OVOMontreal, H4P 2S4, Canada
Withdrawn
KINGSTON HEALTH SCIENCES CENTREKingston, K7L 2V7, Canada
Completed
Alpha Recherche Clinique LB9Quebec, G2J 0C4, Canada
Completed
JSC Seimos gydytojas family medical centerVilnius, LT-01118, Lithuania
Withdrawn
Private hospital and outpatient clinic "Kardiolita"Vilnius, LT-05263, Lithuania
Completed
JSC Gyvenk Silciau Medical Center MaxmedaVilnius, LT-03225, Lithuania
Completed
MHAT NiamedStara Zagora, 6000, Bulgaria
Completed
MC Asklepii OODDupnitza, 2600, Bulgaria
Completed
Medical Center PanaceyaSofia, 1606, Bulgaria
Completed
Spec. Hospital for Active Treatment of Oncological DiseasesSofia, 1233, Bulgaria
Completed
Praxis f. Gynäkologie und GeburtshilfeBernburg, 06406, Germany
Completed
Praxisklinik am RosengartenMannheim, 68165, Germany
Completed
Charité - Campus Virchow-Klinikum (CVK)Berlin, 13353, Germany
Completed
emovis GmbHBerlin, 10629, Germany
Completed
Universitätsklinikum HeidelbergHeidelberg, 69120, Germany
Withdrawn
Vincentius-Diakonissen-Kliniken gAGKarlsruhe, 76199, Germany
Completed
HUS / NaistenklinikkaHelsinki, 00029, Finland
Withdrawn
Seinäjoen keskussairaalaSeinäjoki, FIN 60220, Finland
Withdrawn
Lapin keskussairaalaRovaniemi, 96100, Finland
Withdrawn
Riga East Clinical University Hospital "Gailezers"Riga, LV-1038, Latvia
Completed
I.Vasaraudzes Private PracticeRiga, LV-1011, Latvia
Completed
Vitols and Vitols LtdRiga, LV-1006, Latvia
Completed
AZ Jan Palfijn GentGent, 9000, Belgium
Withdrawn
Matules and Melkas gynecology private clinicRiga, LV-1011, Latvia
Completed
Social Medical Corporation Tokeidai Memorial HospitalSapporo, 060-0031, Japan
Completed
Teine Keijinkai HospitalSapporo, 006-8555, Japan
Completed
Nishikawa Women's Health ClinicSapporo, 060-0061, Japan
Completed
Aiiku Ladies ClinicFunabashi, 274-0071, Japan
Completed
Tokyo Bay Urayasu Ichikawa Medical CenterUrayasu, 279-0001, Japan
Completed
NTT Medical Center TokyoShinagawa-ku, 141-8625, Japan
Completed
Fujisawa City HospitalFujisawa, 251-8550, Japan
Completed
Kashiwazaki ladies clinicSaitama, 330-0855, Japan
Completed
Ibaraki Prefectural Central HospitalKasama, 309-1793, Japan
Completed
Hitachi General HospitalHitachi, 317-0077, Japan
Completed
Toyama Rosai HospitalUozu, 937-0042, Japan
Completed
OMI MEDICAL CENTERKusatsu, 525-8585, Japan
Completed
Suita Tokushukai HospitalSuita, 565-0814, Japan
Completed
Kurashiki Medical ClinicKurashiki, 710-0824, Japan
Completed
JCHO Tokuyama Central HospitalShunan, 745-8522, Japan
Completed
Saiseikai Nagasaki HospitalNagasaki, 850-0003, Japan
Completed
CU Saint-Luc/UZ St-LucBRUXELLES - BRUSSEL, 1200, Belgium
Completed
Ziekenhuis Oost-LimburgGENK, 3600, Belgium
Withdrawn
UZ Leuven GasthuisbergLEUVEN, 3000, Belgium
Completed
UZ GentGENT, 9000, Belgium
Withdrawn
NAP - Rendelo, Private ClinicDebrecen, 4028, Hungary
Withdrawn
Pecsi Tudomanyegyetem Klinikai KozpontPecs, 7624, Hungary
Withdrawn
MH Egeszsegugyi KozpontBudapest, 1062, Hungary
Withdrawn
Debreceni Egyetem Klinikai KozpontDebrecen, 4032, Hungary
Completed
Cortex Study CenterBudapest, 1026, Hungary
Withdrawn
Obudai Egeszsegugyi CentrumDunaujvaros, 2400, Hungary
Completed
Peking University First HospitalBeijing, 100034, China
Withdrawn
Shanghai East Hospital Affiated to Tongji UniversityShanghai, 200123, China
Withdrawn
The First Affiliated Hospital of Xi'an Jiaotong UniversityXi'an, 710061, China
Completed
Wuhan Tongji Reproductive Medicine HospitalWuhan, 430013, China
Completed
First Affiliated Hospital of Guangzhou Medical UniversityGuangzhou, 510120, China
Completed
Guangzhou Women and Children's Medical CenterGuangzhou, 510623, China
Withdrawn
The 2nd Hospital of Hebei Medical UniversityShijiazhuang, 050000, China
Completed
Women's Hospital School of Medicine Zhejiang UniversityHangzhou, 310006, China
Withdrawn
The Second Affliated Hospital of Wenzhou Medicial UniversityWenzhou, 325000, China
Withdrawn
SichuanAcademyofMedicalSciences&SichuanProvincialPeople'sHosChengdu, 610072, China
Withdrawn
The First Affiliated Hospital of Guangzhou University of TCMGuangzhou, 510405, China
Withdrawn
West China Second University HospitalChengdu, 610066, China
Withdrawn
Chengdu Women & Children's Central HospitalChengdu, 610091, China
Withdrawn
Zhongda Hospital Southeast UniversityNanjing, 210009, China
Completed
The Second Affiliated Hospital of Nanjing Medical universityNanjing, 210011, China
Completed
Paramount Research Solutions-College ParkCollege Park, 30349, United States
Completed
University of Alabama at BirminghamBirmingham, 35294-0026, United States
Completed
Southern Clinical Research Associates LLCMetairie, 70001, United States
Withdrawn
Unified Women’s Clinical ResearchGreensboro, 27408, United States
Terminated
A Premier Medical Research of Florida, LLCOrange City, 32763, United States
Withdrawn
University of Illinois at ChicagoChicago, 60612, United States
Completed
Eastern Virginia Medical SchoolNorfolk, 23507, United States
Completed
Aventiv Research - DublinDublin, 43016, United States
Withdrawn
Willowbend Health and Wellness AssociatesPlano, 75093, United States
Withdrawn
Suncoast Clinical ResearchPalm Harbor, 34684, United States
Completed
Journey Medical ResearchSnellville, 30078, United States
Completed
Carolina Women's Research & Wellness CenterDurham, 27713, United States
Completed
Seattle Clinical Research CenterSeattle, 98105, United States
Completed
Clinical Inquest Center, Ltd.Beavercreek, 45432, United States
Withdrawn
Women's Health AllianceRaleigh, 27607, United States
Completed
UT Health Women’s Research Center at Memorial CityHouston, 77024, United States
Completed
University Hospitals Landerbrook Health CenterMayfield Heights, 44124, United States
Completed
SUNY Downstate Medical CenterBrooklyn, 11203, United States
Completed
Chattanooga Medical Research, LLCChattanooga, 37404, United States
Completed
Medisense, Inc.Atlanta, 30363, United States
Completed
Virginia Physicians For WomenNorth Chesterfield, 23235, United States
Completed
Continental Clinical Solutions, LLCTowson, 21204, United States
Completed
Helix Biomedics, LLCBoynton Beach, 33435, United States
Completed
Diagnamics, Inc.Encinitas, 92024, United States
Completed
Lyndhurst Clinical ResearchWinston-Salem, 27103, United States
Completed
Advanced Women's Health InstituteGreenwood Village, 80111, United States
Completed
Mobile Ob-Gyn, PCMobile, 36608-6703, United States
Completed
Advances in HealthPearland, 77584, United States
Completed
Wayne State University Physicians GroupDetroit, 48201, United States
Withdrawn
Women's Medical Research Group, LLCClearwater, 33759, United States
Withdrawn
John Hopkins Outpatient CenterBaltimore, 21287, United States
Completed
Biopharma Informatic, Inc.Houston, 77043, United States
Withdrawn
Sekine, Rasner & Brock and Associates, MD, LLCJacksonville, 32223, United States
Completed
Office of Dr. James A. Simon, MDWashington, 20036, United States
Completed
Suncoast Clinical Research Center, Inc.New Port Richey, 34652, United States
Withdrawn
Medical University of South CarolinaCharleston, 29425, United States
Completed
Bosque Womens CareAlbuquerque, 87109, United States
Not yet recruiting
Physician Care Clinical ResearchSarasota, 34239, United States
Withdrawn
Houston Center for Clinical Research, LLCSugarland, 77479, United States
Withdrawn
Medical Center for Clinical ResearchSan Diego, 92120, United States
Completed
HWC Women’s Research CenterEnglewood, 45322, United States
Withdrawn
Atlanta Women's Research Institute, Inc. - AtlantaAtlanta, 30342, United States
Completed
Augusta University Medical CenterAugusta, 30912, United States
Withdrawn
Robert Wood Johnson University HospitalNew Brunswick, 08901, United States
Withdrawn
Paramount Research Solutions-NashvilleNashville, 37203, United States
Completed
Medical Research Center of Memphis, LLCMemphis, 38120, United States
Completed
Palmetto Clinical ResearchSummerville, 29485, United States
Completed
Yokosuka Kyosai HospitalYokosuka, 238-8558, Japan
Completed
Japanese Red Cross Kumamoto HospitalKumamoto, 861-8520, Japan
Completed
ARETAIEION University HospitalAthens, 11528, Greece
Withdrawn
ELENA VENIZELOU HospitalAthens, 115 21, Greece
Withdrawn
General Hospital of Thessaloniki PapageorgiouThessaloniki, 56403, Greece
Completed
University General Hospital of Patras | Univ Obs & Gynae CliPatra, 26504, Greece
Completed
V. Jonaitienes private gynecology clinicVilnius, LT-01123, Lithuania
Completed
ClinSearch, LLCChattanooga, 37421, United States
Completed
International Clinical Research-Tennessee LLC.Murfreesboro, 37130, United States
Withdrawn
Clinical Trials Management, LLC - MetairieMetairie, 70006, United States
Withdrawn
Clinical Trials of Texas, Inc.San Antonio, 78229, United States
Completed
Centex Studies, Inc.Houston, 77090, United States
Completed
Alliance for Multispecialty Research, LLC - Fort MeyersFort Myers, 33912, United States
Withdrawn
Jersey Shore University Medical CenterNeptune, 07753, United States
Withdrawn
Comprehensive Clinical TrialsWest Palm Beach, 33409, United States
Completed
Accel Research Sites - Cahaba Medical CareBirmingham, 35218, United States
Completed
Discovery Clinical Trials - DallasDallas, 75230, United States
Completed
West Coast OB/GYN AssociatesSan Diego, 92123, United States
Completed
SZTE ÁOK Szent Györgyi Albert Klinikai KozpontSzeged, 6725, Hungary
Completed
I.Dinsbergas Physician PracticeRiga, LV-1013, Latvia
Completed
Nagasaki University HospitalNagasaki, 852-8501, Japan
Completed
Centex Studies, Inc.Houston, 77058, United States
Completed
Tidewater Clinical Research, Inc.Norfolk, 23456, United States
Withdrawn
Olympia Clinical TrialsLos Angeles, 90036, United States
Completed
Clinical Research PrimeIdaho Falls, 83404, United States
Completed
Precision Trials, AZ, LLCPhoenix, 85032, United States
Withdrawn
The Second Hospital of Jilin UniversityChangchun, 130000, China
Completed
Sykehuset i Vestfold HF, TønsbergTønsberg, 3116, Norway
Withdrawn
Sir Run Run Shaw Hospital, Zhejiang University School of MedHangzhou, 310016, China
Completed
Essential Women’s Health AssociatesLas Vegas, 89113, United States
Completed
Latvian Maritime Medicine CenterRiga, LV-1005, Latvia
Withdrawn
Signature GYN Services, PllcFort Worth, 76104-4145, United States
Withdrawn
The Second Affiliated Hospital of Shanxi Medical UniversityTaiyuan, 030001, China
Completed
Beijing Obstetrics and Gynecology Hospital,Capital Med.Uni.Beijing, 100026, China
Withdrawn
1st Riga Clinical HospitalRiga, LV-1001, Latvia
Completed
Lääkärikeskus GynekoOulu, 90100, Finland
Completed
Sou ClinicYotsukaido, 284-0001, Japan
Completed
SHOGAT Prof Dimitar StamatovVarna, 9000, Bulgaria
Withdrawn
Praxis Hr. Dr. S. FiedlerAachen, 52074, Germany
Withdrawn
Rub-Int Noi EgeszsegcentrumSzekesfehervar, 8000, Hungary
Withdrawn
Medplus NordrheinKrefeld, 47799, Germany
Completed
Oslo Universitetssykehus HF, UllevålOslo, 0450, Norway
Completed
Kirkeparken SpesialistpraksisFredrikstad, 1605, Norway
Withdrawn
Stavanger UniversitetssjukehusStavanger, 4011, Norway
Completed
ULMUS, s r.o.Hlohovec, 920 01, Slovakia
Completed
A.O.U.I. VeronaVerona, 37126, Italy
Completed
Fondazione IRCCS Ca' Granda Ospedale Maggiore PoliclinicoMilano, 20122, Italy
Completed
A.O.U. CareggiFirenze, 50134, Italy
Completed
IRCCS Ospedale Policlinico San MartinoGenova, 16132, Italy
Completed
Fondazione Policlinico Universitario Agostino Gemelli IRCCSRoma, 00168, Italy
Withdrawn
Ospedale San Raffaele s.r.l.Milano, 20132, Italy
Completed
ASST Sette LaghiVarese, 21100, Italy
Withdrawn
A.O.U. di Bologna Policlinico S.Orsola MalpighiBologna, 40138, Italy
Completed
Universitätsklinikum AKH WienWien, 1090, Austria
Completed
Universitätsklinikum AKH WienWien, 1090, Austria
Completed
Medizinische Universität GrazGraz, 8036, Austria
Completed
Fakultni nemocnice BrnoBrno, 625 00, Czechia
Completed
Gynekologie Meda s.r.o. - LidickaBrno - stred, 60200, Czechia
Completed
Fakultní nemocnice BulovkaPraha 8, 180 81, Czechia
Completed
Dr. Smrhova-KovacsTabor, 39003, Czechia
Withdrawn
G-Centrum Olomouc s.r.o. Dr. SkrivanekOlomouc, 772 00, Czechia
Completed
GynCare MUDr. Michael Svec s.r.o.Plzen, 326 00, Czechia
Completed
GYN-MIKA s.r.o.Ceske Budejovice, 370 01, Czechia
Completed
Gynekologie Studentsky dum s.r.o.Praha 6, 160 00, Czechia
Completed
Centrum gynekologicke rehabilitacePisek, 39701, Czechia
Completed
GYNERAPraha 5, 156 00, Czechia
Completed
GA Lucenec s.r.oLucenec, 984 01, Slovakia
Withdrawn
BrenCare, s.r.o.Poprad, 058 01, Slovakia
Completed
Virina sano, s.r.o. Gynekologicko porodnicka ambulanciaVelky Krtis, 990 01, Slovakia
Withdrawn
GYN-FIV a.s.Bratislava, 821 01, Slovakia
Withdrawn
Hospital Clínic i Provincial de BarcelonaBarcelona, 08036, Spain
Withdrawn
Hospital Clínico Universitario San CarlosMadrid, 28040, Spain
Completed
Hospital de la Santa Creu i de Sant Pau | GinecologiaBarcelona, 08041, Spain
Completed
Hospital Universitario 12 de OctubreMadrid, 28041, Spain
Withdrawn
Complejo Hospitalario de NavarraPamplona, 31008, Spain
Withdrawn
Hospital Universitario "La Paz"Madrid, 28046, Spain
Withdrawn
Hospital Universitario Virgen del RocíoSevilla, 41013, Spain
Completed
Hospital de BasurtoBilbao, 48013, Spain
Completed
Hospital General Universitario de ValenciaValencia, 46014, Spain
Completed
NZOZ NOVITA, Specjalistyczne Gabinety Lekarskie S.CLublin, 20-632, Poland
Completed
Specjalistyczny Gabinet Ginekologiczno-PolozniczyLublin, 20-400, Poland
Completed
CLINICAL MEDICAL RESEARCH Sp. z o. o.Katowice, 40-156, Poland
Completed
Vita Longa Sp. z o.o.Katowice, 40-748, Poland
Withdrawn
Centrum Badawcze Wspolczesnej TerapiiWarszawa, 02-679, Poland
Completed
MICS Centrum Medyczne TorunBydgoszcz, 85-065, Poland
Completed
Gabinet Ginekologiczny Janusz TomaszewskiBialystok, 15-244, Poland
Completed
NZOZ MEDEM Wilk Sp. j.Katowice, 40-301, Poland
Completed
MTZ Clinical Research Sp z o.o.Warszawa, 02-106, Poland
Completed
Prywatny Gabinet Lekarski Ginekologia, Poloznictwo i Ultr.Lodz, 90-602, Poland
Completed
VitroLive Sp. z o.o.Szczecin, 70-483, Poland
Completed
Medical Concierge Centrum MedyczneWarszawa, 02-798, Poland
Completed
Clinic EliteTartu, 50407, Estonia
Completed
Parnu HospitalParnu, 80010, Estonia
Withdrawn
East Tallinn Central HospitalTallinn, 10138, Estonia
Withdrawn
Hospital Universitario de Álava - Sede TxagorritxuVitoria, 01009, Spain
Completed
The Ottawa HospitalOttawa, K1Y4E9, Canada
Completed
Clinique OVOMontreal, H4P 2S4, Canada
Withdrawn
KINGSTON HEALTH SCIENCES CENTREKingston, K7L 2V7, Canada
Completed
Alpha Recherche Clinique LB9Quebec, G2J 0C4, Canada
Completed
JSC Seimos gydytojas family medical centerVilnius, LT-01118, Lithuania
Withdrawn
Private hospital and outpatient clinic "Kardiolita"Vilnius, LT-05263, Lithuania
Completed
JSC Gyvenk Silciau Medical Center MaxmedaVilnius, LT-03225, Lithuania
Completed
MHAT NiamedStara Zagora, 6000, Bulgaria
Completed
MC Asklepii OODDupnitza, 2600, Bulgaria
Completed
Medical Center PanaceyaSofia, 1606, Bulgaria
Completed
Spec. Hospital for Active Treatment of Oncological DiseasesSofia, 1233, Bulgaria
Completed
Praxis f. Gynäkologie und GeburtshilfeBernburg, 06406, Germany
Completed
Praxisklinik am RosengartenMannheim, 68165, Germany
Completed
Charité - Campus Virchow-Klinikum (CVK)Berlin, 13353, Germany
Completed
emovis GmbHBerlin, 10629, Germany
Completed
Universitätsklinikum HeidelbergHeidelberg, 69120, Germany
Withdrawn
Vincentius-Diakonissen-Kliniken gAGKarlsruhe, 76199, Germany
Completed
HUS / NaistenklinikkaHelsinki, 00029, Finland
Withdrawn
Seinäjoen keskussairaalaSeinäjoki, FIN 60220, Finland
Withdrawn
Lapin keskussairaalaRovaniemi, 96100, Finland
Withdrawn
Riga East Clinical University Hospital "Gailezers"Riga, LV-1038, Latvia
Completed
I.Vasaraudzes Private PracticeRiga, LV-1011, Latvia
Completed
Vitols and Vitols LtdRiga, LV-1006, Latvia
Completed
AZ Jan Palfijn GentGent, 9000, Belgium
Withdrawn
Matules and Melkas gynecology private clinicRiga, LV-1011, Latvia
Completed
Social Medical Corporation Tokeidai Memorial HospitalSapporo, 060-0031, Japan
Completed
Teine Keijinkai HospitalSapporo, 006-8555, Japan
Completed
Nishikawa Women's Health ClinicSapporo, 060-0061, Japan
Completed
Aiiku Ladies ClinicFunabashi, 274-0071, Japan
Completed
Tokyo Bay Urayasu Ichikawa Medical CenterUrayasu, 279-0001, Japan
Completed
NTT Medical Center TokyoShinagawa-ku, 141-8625, Japan
Completed
Fujisawa City HospitalFujisawa, 251-8550, Japan
Completed
Kashiwazaki ladies clinicSaitama, 330-0855, Japan
Completed
Ibaraki Prefectural Central HospitalKasama, 309-1793, Japan
Completed
Hitachi General HospitalHitachi, 317-0077, Japan
Completed
Toyama Rosai HospitalUozu, 937-0042, Japan
Completed
OMI MEDICAL CENTERKusatsu, 525-8585, Japan
Completed
Suita Tokushukai HospitalSuita, 565-0814, Japan
Completed
Kurashiki Medical ClinicKurashiki, 710-0824, Japan
Completed
JCHO Tokuyama Central HospitalShunan, 745-8522, Japan
Completed
Saiseikai Nagasaki HospitalNagasaki, 850-0003, Japan
Completed
CU Saint-Luc/UZ St-LucBRUXELLES - BRUSSEL, 1200, Belgium
Completed
Ziekenhuis Oost-LimburgGENK, 3600, Belgium
Withdrawn
UZ Leuven GasthuisbergLEUVEN, 3000, Belgium
Completed
UZ GentGENT, 9000, Belgium
Withdrawn
NAP - Rendelo, Private ClinicDebrecen, 4028, Hungary
Withdrawn
Pecsi Tudomanyegyetem Klinikai KozpontPecs, 7624, Hungary
Withdrawn
MH Egeszsegugyi KozpontBudapest, 1062, Hungary
Withdrawn
Debreceni Egyetem Klinikai KozpontDebrecen, 4032, Hungary
Completed
Cortex Study CenterBudapest, 1026, Hungary
Withdrawn
Obudai Egeszsegugyi CentrumDunaujvaros, 2400, Hungary
Completed
Peking University First HospitalBeijing, 100034, China
Withdrawn
Shanghai East Hospital Affiated to Tongji UniversityShanghai, 200123, China
Withdrawn
The First Affiliated Hospital of Xi'an Jiaotong UniversityXi'an, 710061, China
Completed
Wuhan Tongji Reproductive Medicine HospitalWuhan, 430013, China
Completed
First Affiliated Hospital of Guangzhou Medical UniversityGuangzhou, 510120, China
Completed
Guangzhou Women and Children's Medical CenterGuangzhou, 510623, China
Withdrawn
The 2nd Hospital of Hebei Medical UniversityShijiazhuang, 050000, China
Completed
Women's Hospital School of Medicine Zhejiang UniversityHangzhou, 310006, China
Withdrawn
The Second Affliated Hospital of Wenzhou Medicial UniversityWenzhou, 325000, China
Withdrawn
SichuanAcademyofMedicalSciences&SichuanProvincialPeople'sHosChengdu, 610072, China
Withdrawn
The First Affiliated Hospital of Guangzhou University of TCMGuangzhou, 510405, China
Withdrawn
West China Second University HospitalChengdu, 610066, China
Withdrawn
Chengdu Women & Children's Central HospitalChengdu, 610091, China
Withdrawn
Zhongda Hospital Southeast UniversityNanjing, 210009, China
Completed
The Second Affiliated Hospital of Nanjing Medical universityNanjing, 210011, China
Completed
Paramount Research Solutions-College ParkCollege Park, 30349, United States
Completed
University of Alabama at BirminghamBirmingham, 35294-0026, United States
Completed
Southern Clinical Research Associates LLCMetairie, 70001, United States
Withdrawn
Unified Women’s Clinical Research - GreensboroGreensboro, 27408, United States
Terminated
A Premier Medical Research of Florida, LLCOrange City, 32763, United States
Withdrawn
University of Illinois at ChicagoChicago, 60612, United States
Completed
Eastern Virginia Medical SchoolNorfolk, 23507, United States
Completed
Centricity Research formerly Aventiv - DublinDublin, 43016, United States
Withdrawn
Willowbend Health and Wellness AssociatesPlano, 75093, United States
Withdrawn
Suncoast Clinical ResearchPalm Harbor, 34684, United States
Completed
Journey Medical ResearchSnellville, 30078, United States
Completed
Carolina Women's Research & Wellness CenterDurham, 27713, United States
Completed
Seattle Clinical Research CenterSeattle, 98105, United States
Completed
Clinical Inquest Center, Ltd.Beavercreek, 45432, United States
Withdrawn
Women's Health AllianceRaleigh, 27607, United States
Completed
UT Health Women’s Research Center at Memorial CityHouston, 77024, United States
Completed
University Hospitals Landerbrook Health CenterMayfield Heights, 44124, United States
Completed
SUNY Downstate Medical CenterBrooklyn, 11203, United States
Completed
Chattanooga Medical Research, LLCChattanooga, 37404, United States
Completed
Medisense, Inc.Atlanta, 30363, United States
Completed
Virginia Physicians For WomenNorth Chesterfield, 23235, United States
Completed
Continental Clinical Solutions, LLCTowson, 21204, United States
Completed
Helix Biomedics, LLCBoynton Beach, 33435, United States
Completed
Diagnamics, Inc.Encinitas, 92024, United States
Completed
Lyndhurst Clinical ResearchWinston-Salem, 27103, United States
Completed
Advanced Women's Health InstituteGreenwood Village, 80111, United States
Completed
Mobile Ob-Gyn, PCMobile, 36608-6703, United States
Completed
Advances in HealthPearland, 77584, United States
Completed
Wayne State University Physicians GroupDetroit, 48201, United States
Withdrawn
Women's Medical Research Group, LLCClearwater, 33759, United States
Withdrawn
John Hopkins Outpatient CenterBaltimore, 21287, United States
Completed
Biopharma Informatic, Inc.Houston, 77043, United States
Withdrawn
Sekine, Rasner & Brock and Associates, MD, LLCJacksonville, 32223, United States
Completed
Office of Dr. James A. Simon, MDWashington, 20036, United States
Completed
Suncoast Clinical Research Center, Inc.New Port Richey, 34652, United States
Withdrawn
Medical University of South CarolinaCharleston, 29425, United States
Completed
Bosque Womens CareAlbuquerque, 87109, United States
Not yet recruiting
Physician Care Clinical ResearchSarasota, 34239, United States
Withdrawn
Houston Center for Clinical Research, LLCSugarland, 77479, United States
Withdrawn
Medical Center for Clinical ResearchSan Diego, 92120, United States
Completed
HWC Women’s Research CenterEnglewood, 45322, United States
Withdrawn
Atlanta Women's Research Institute, Inc. - AtlantaAtlanta, 30342, United States
Completed
Augusta University Medical CenterAugusta, 30912, United States
Withdrawn
Robert Wood Johnson University HospitalNew Brunswick, 08901, United States
Withdrawn
Paramount Research Solutions-NashvilleNashville, 37203, United States
Completed
Medical Research Center of Memphis, LLCMemphis, 38120, United States
Completed
Palmetto Clinical ResearchSummerville, 29485, United States
Completed
Yokosuka Kyosai HospitalYokosuka, 238-8558, Japan
Completed
Japanese Red Cross Kumamoto HospitalKumamoto, 861-8520, Japan
Completed
ARETAIEION University HospitalAthens, 11528, Greece
Withdrawn
ELENA VENIZELOU HospitalAthens, 115 21, Greece
Withdrawn
General Hospital of Thessaloniki PapageorgiouThessaloniki, 56403, Greece
Completed
University General Hospital of Patras | Univ Obs & Gynae CliPatra, 26504, Greece
Completed
V. Jonaitienes private gynecology clinicVilnius, LT-01123, Lithuania
Completed
ClinSearch, LLCChattanooga, 37421, United States
Completed
International Clinical Research-Tennessee LLC.Murfreesboro, 37130, United States
Withdrawn
Clinical Trials Management, LLC - MetairieMetairie, 70006, United States
Withdrawn
Clinical Trials of Texas, Inc.San Antonio, 78229, United States
Completed
Centex Studies, Inc.Houston, 77090, United States
Completed
Alliance for Multispecialty Research, LLC - Fort MeyersFort Myers, 33912, United States
Withdrawn
Jersey Shore University Medical CenterNeptune, 07753, United States
Withdrawn
Comprehensive Clinical TrialsWest Palm Beach, 33409, United States
Completed
Accel Research Sites - Cahaba Medical CareBirmingham, 35218, United States
Completed
Discovery Clinical Trials - DallasDallas, 75230, United States
Completed
West Coast OB/GYN AssociatesSan Diego, 92123, United States
Completed
SZTE ÁOK Szent Györgyi Albert Klinikai KozpontSzeged, 6725, Hungary
Completed
I.Dinsbergas Physician PracticeRiga, LV-1013, Latvia
Completed
Nagasaki University HospitalNagasaki, 852-8501, Japan
Completed
Centex Studies, Inc.Houston, 77058, United States
Completed
Tidewater Clinical Research, Inc.Norfolk, 23456, United States
Withdrawn
Olympia Clinical TrialsLos Angeles, 90036, United States
Completed
Clinical Research PrimeIdaho Falls, 83404, United States
Completed
Precision Trials, AZ, LLCPhoenix, 85032, United States
Withdrawn
The Second Hospital of Jilin UniversityChangchun, 130000, China
Completed
Sykehuset i Vestfold HF, TønsbergTønsberg, 3116, Norway
Withdrawn
Sir Run Run Shaw Hospital, Zhejiang University School of MedHangzhou, 310016, China
Completed
Essential Women’s Health AssociatesLas Vegas, 89113, United States
Completed
Latvian Maritime Medicine CenterRiga, LV-1005, Latvia
Withdrawn
Signature GYN Services, PllcFort Worth, 76104-4145, United States
Withdrawn
The Second Affiliated Hospital of Shanxi Medical UniversityTaiyuan, 030001, China
Completed
Beijing Obstetrics and Gynecology Hospital,Capital Med.Uni.Beijing, 100026, China
Withdrawn
1st Riga Clinical HospitalRiga, LV-1001, Latvia
Completed
Lääkärikeskus GynekoOulu, 90100, Finland
Completed
Sou ClinicYotsukaido, 284-0001, Japan
Completed
SHOGAT Prof Dimitar StamatovVarna, 9000, Bulgaria
Withdrawn
Praxis Hr. Dr. S. FiedlerAachen, 52074, Germany
Withdrawn
Rub-Int Noi EgeszsegcentrumSzekesfehervar, 8000, Hungary
Withdrawn
Medplus NordrheinKrefeld, 47799, Germany

Primary Outcome

  • Absolute change in mean worst endometriosis associated pelvic pain (EAPP), primary per protocol set (pPPS)
    The worst EAPP was measured daily on the 0-10 Numerical Rating Scale (NRS) by item 1 of the Endometriosis Symptom Diary (ESD). In question 1, participants were asked to rate the 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. The absolute change in mean worst EAPP was from baseline (last 28 days before the first intake of study drug) to end of intervention (last 28 days ending with the last intake of study drug planned on Day 84 [+3]). The time frame of 28 days captures a menstrual cycle on average.
    date_rangeTime Frame:
    change from baseline to week 12

Secondary Outcome

  • Least Squares Mean (SE) changes in worst EAPP from baseline to week 12, per protocol set
    date_rangeTime Frame:
    change from baseline to week 12
  • Number of participants with treatment-emergent adverse events (TEAE)
    date_rangeTime Frame:
    up to 14 days after the last study medication intake

Trial design

A randomized, double-blind, open for active comparator, parallel-group, multicenter Phase 2b study to assess the efficacy and safety of three different doses of P2X3 antagonist (BAY1817080) versus placebo and elagolix 150 mg in women with symptomatic endometriosis
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
N/A
Assignment
Parallel Assignment
Trial Arms
5