Trial Condition(s):
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 (SCHUMANN)
Bayer Identifier:
20584
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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
Inclusion Criteria
- 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.
Exclusion Criteria
- 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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Oslo Universitetssykehus HF, Ullevål Oslo, Norway, 0450 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kirkeparken Spesialistpraksis Fredrikstad, Norway, 1605 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations ULMUS, s r.o. Hlohovec, Slovakia, 920 01 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations A.O.U.I. Verona Verona, Italy, 37126 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milano, Italy, 20122 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations A.O.U. Careggi Firenze, Italy, 50134 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations IRCCS Ospedale Policlinico San Martino Genova, Italy, 16132 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fondazione Policlinico Universitario Agostino Gemelli IRCCS Roma, Italy, 00168 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations ASST Sette Laghi Varese, Italy, 21100 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Universitätsklinikum AKH Wien Wien, Austria, 1090 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Universitätsklinikum AKH Wien Wien, Austria, 1090 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Medizinische Universität Graz Graz, Austria, 8036 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fakultni nemocnice Brno Brno, Czech Republic, 625 00 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Gynekologie Meda s.r.o. - Lidicka Brno - stred, Czech Republic, 60200 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fakultní nemocnice Bulovka Praha 8, Czech Republic, 180 81 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Dr. Smrhova-Kovacs Tabor, Czech Republic, 39003 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations GynCare MUDr. Michael Svec s.r.o. Plzen, Czech Republic, 326 00 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations GYN-MIKA s.r.o. Ceske Budejovice, Czech Republic, 370 01 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Gynekologie Studentsky dum s.r.o. Praha 6, Czech Republic, 160 00 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centrum gynekologicke rehabilitace Pisek, Czech Republic, 39701 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations GYNERA Praha 5, Czech Republic, 156 00 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations GA Lucenec s.r.o Lucenec, Slovakia, 984 01 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Virina sano, s.r.o. Gynekologicko porodnicka ambulancia Velky Krtis, Slovakia, 990 01 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital de la Santa Creu i de Sant Pau | Ginecologia Barcelona, Spain, 08041 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Universitario 12 de Octubre Madrid, Spain, 28041 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital de Basurto Bilbao, Spain, 48013 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital General Universitario de Valencia Valencia, Spain, 46014 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations NZOZ NOVITA, Specjalistyczne Gabinety Lekarskie S.C Lublin, Poland, 20-632 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Specjalistyczny Gabinet Ginekologiczno-Polozniczy Lublin, Poland, 20-400 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations CLINICAL MEDICAL RESEARCH Sp. z o. o. Katowice, Poland, 40-156 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Vita Longa Sp. z o.o. Katowice, Poland, 40-748 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations MICS Centrum Medyczne Torun Bydgoszcz, Poland, 85-065 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Gabinet Ginekologiczny Janusz Tomaszewski Bialystok, Poland, 15-244 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations NZOZ MEDEM Wilk Sp. j. Katowice, Poland, 40-301 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations MTZ Clinical Research Sp z o.o. Warszawa, Poland, 02-106 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Prywatny Gabinet Lekarski Ginekologia, Poloznictwo i Ultr. Lodz, Poland, 90-602 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations VitroLive Sp. z o.o. Szczecin, Poland, 70-483 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Medical Concierge Centrum Medyczne Warszawa, Poland, 02-798 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Clinic Elite Tartu, Estonia, 50407 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Parnu Hospital Parnu, Estonia, 80010 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations The Ottawa Hospital Ottawa, Canada, K1Y4E9 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Clinique OVO Montreal, Canada, H4P 2S4 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Alpha Recherche Clinique LB9 Quebec, Canada, G2J 0C4 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations JSC Seimos gydytojas family medical center Vilnius, Lithuania, LT-01118 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations JSC Gyvenk Silciau Medical Center Maxmeda Vilnius, Lithuania, LT-03225 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations MHAT Niamed Stara Zagora, Bulgaria, 6000 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations MC Asklepii OOD Dupnitza, Bulgaria, 2600 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Medical Center Panaceya Sofia, Bulgaria, 1606 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Spec. Hospital for Active Treatment of Oncological Diseases Sofia, Bulgaria, 1233 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Praxis f. Gynäkologie und Geburtshilfe Bernburg, Germany, 06406 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Praxisklinik am Rosengarten Mannheim, Germany, 68165 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Charité - Campus Virchow-Klinikum (CVK) Berlin, Germany, 13353 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations emovis GmbH Berlin, Germany, 10629 | Status Completed | Contact Us: E-mail: clinical-tri[email protected] Phone: (+)1-888-84 22937 |
Locations Universitätsklinikum Heidelberg Heidelberg, Germany, 69120 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations HUS / Naistenklinikka Helsinki, Finland, 00029 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations I.Vasaraudzes Private Practice Riga, Latvia, LV-1011 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Vitols and Vitols Ltd Riga, Latvia, LV-1006 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations AZ Jan Palfijn Gent Gent, Belgium, 9000 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Social Medical Corporation Tokeidai Memorial Hospital Sapporo, Japan, 060-0031 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Teine Keijinkai Hospital Sapporo, Japan, 006-8555 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Nishikawa Women's Health Clinic Sapporo, Japan, 060-0061 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Aiiku Ladies Clinic Funabashi, Japan, 274-0071 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tokyo Bay Urayasu Ichikawa Medical Center Urayasu, Japan, 279-0001 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations NTT Medical Center Tokyo Shinagawa-ku, Japan, 141-8625 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fujisawa City Hospital Fujisawa, Japan, 251-8550 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kashiwazaki ladies clinic Saitama, Japan, 330-0855 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ibaraki Prefectural Central Hospital Kasama, Japan, 309-1793 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hitachi General Hospital Hitachi, Japan, 317-0077 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Toyama Rosai Hospital Uozu, Japan, 937-0042 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations OMI MEDICAL CENTER Kusatsu, Japan, 525-8585 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Suita Tokushukai Hospital Suita, Japan, 565-0814 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kurashiki Medical Clinic Kurashiki, Japan, 710-0824 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations JCHO Tokuyama Central Hospital Shunan, Japan, 745-8522 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Saiseikai Nagasaki Hospital Nagasaki, Japan, 850-0003 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations CU Saint-Luc/UZ St-Luc BRUXELLES - BRUSSEL, Belgium, 1200 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ziekenhuis Oost-Limburg GENK, Belgium, 3600 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations UZ Gent GENT, Belgium, 9000 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Cortex Study Center Budapest, Hungary, 1026 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Peking University First Hospital Beijing, China, 100034 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Wuhan Tongji Reproductive Medicine Hospital Wuhan, China, 430013 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations First Affiliated Hospital of Guangzhou Medical University Guangzhou, China, 510120 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Guangzhou Women and Children's Medical Center Guangzhou, China, 510623 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Women's Hospital School of Medicine Zhejiang University Hangzhou, China, 310006 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations The Second Affiliated Hospital of Nanjing Medical university Nanjing, China, 210011 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Paramount Research Solutions-College Park College Park, United States, 30349 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University of Alabama at Birmingham Birmingham, United States, 35294-0026 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Southern Clinical Research Associates LLC Metairie, United States, 70001 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations A Premier Medical Research of Florida, LLC Orange City, United States, 32763 | Status Terminated | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Eastern Virginia Medical School Norfolk, United States, 23507 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centricity Research formerly Aventiv - Dublin Dublin, United States, 43016 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Journey Medical Research Snellville, United States, 30078 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Carolina Women's Research & Wellness Center Durham, United States, 27713 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Seattle Clinical Research Center Seattle, United States, 98105 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Clinical Inquest Center, Ltd. Beavercreek, United States, 45432 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations UT Health Women’s Research Center at Memorial City Houston, United States, 77024 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University Hospitals Landerbrook Health Center Mayfield Heights, United States, 44124 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations SUNY Downstate Medical Center Brooklyn, United States, 11203 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Chattanooga Medical Research, LLC Chattanooga, United States, 37404 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Medisense, Inc. Atlanta, United States, 30363 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Virginia Physicians For Women North Chesterfield, United States, 23235 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Continental Clinical Solutions, LLC Towson, United States, 21204 | Status Completed | Contact Us: E-mail: clinical-trials-c[email protected] Phone: (+)1-888-84 22937 |
Locations Helix Biomedics, LLC Boynton Beach, United States, 33435 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Diagnamics, Inc. Encinitas, United States, 92024 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Lyndhurst Clinical Research Winston-Salem, United States, 27103 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Advanced Women's Health Institute Greenwood Village, United States, 80111 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Mobile Ob-Gyn, PC Mobile, United States, 36608-6703 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Advances in Health Pearland, United States, 77584 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Wayne State University Physicians Group Detroit, United States, 48201 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Biopharma Informatic, Inc. Houston, United States, 77043 | Status Completed | Contact Us: E-mail: [email protected]er.com Phone: (+)1-888-84 22937 |
Locations Office of Dr. James A. Simon, MD Washington, United States, 20036 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Suncoast Clinical Research Center, Inc. New Port Richey, United States, 34652 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Bosque Womens Care Albuquerque, United States, 87109 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Physician Care Clinical Research Sarasota, United States, 34239 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations HWC Women’s Research Center Englewood, United States, 45322 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Augusta University Medical Center Augusta, United States, 30912 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Medical Research Center of Memphis, LLC Memphis, United States, 38120 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Palmetto Clinical Research Summerville, United States, 29485 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Yokosuka Kyosai Hospital Yokosuka, Japan, 238-8558 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Japanese Red Cross Kumamoto Hospital Kumamoto, Japan, 861-8520 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations ARETAIEION University Hospital Athens, Greece, 11528 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University General Hospital of Patras | Univ Obs & Gynae Cli Patra, Greece, 26504 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations V. Jonaitienes private gynecology clinic Vilnius, Lithuania, LT-01123 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations ClinSearch, LLC Chattanooga, United States, 37421 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations International Clinical Research-Tennessee LLC. Murfreesboro, United States, 37130 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centex Studies, Inc. Houston, United States, 77090 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Alliance for Multispecialty Research, LLC - Fort Meyers Fort Myers, United States, 33912 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Accel Research Sites - Cahaba Medical Care Birmingham, United States, 35218 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Discovery Clinical Trials - Dallas Dallas, United States, 75230 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations West Coast OB/GYN Associates San Diego, United States, 92123 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont Szeged, Hungary, 6725 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations I.Dinsbergas Physician Practice Riga, Latvia, LV-1013 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Nagasaki University Hospital Nagasaki, Japan, 852-8501 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centex Studies, Inc. Houston, United States, 77058 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tidewater Clinical Research, Inc. Norfolk, United States, 23456 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Clinical Research Prime Idaho Falls, United States, 83404 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Precision Trials, AZ, LLC Phoenix, United States, 85032 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sykehuset i Vestfold HF, Tønsberg Tønsberg, Norway, 3116 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Essential Women’s Health Associates Las Vegas, United States, 89113 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Latvian Maritime Medicine Center Riga, Latvia, LV-1005 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Beijing Obstetrics and Gynecology Hospital,Capital Med.Uni. Beijing, China, 100026 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Lääkärikeskus Gyneko Oulu, Finland, 90100 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sou Clinic Yotsukaido, Japan, 284-0001 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations SHOGAT Prof Dimitar Stamatov Varna, Bulgaria, 9000 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations The Ottawa Hospital Ottawa, Canada, K1H 7W9 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Aventiv Research - Dublin Dublin, United States, 43016 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
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
Primary Outcome
- Absolute change in mean worst EAPP from baseline to end of interventionEndometriosis associated pelvic pain (EAPP) will be measured daily on the numerical rating scale (NRS) ranging from 0 to 10 by item 1 of the Endometriosis Symptom Diary (ESD). The higher number indicates a higher level of pain experienceTimeframe: At baseline (last 28 days before start of study drug) and at day 57-84 (+3)
Secondary Outcome
- Number of participants with treatment-emergent adverse eventsAny event arising or worsening after the start of study drug administration until 14 days after the last study medication intakeTimeframe: From start of study drug administration until 14 days after the last study medication intake
Additional Information
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