Study Stopped
Study terminated by Sponsor
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
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
2 other identifiers
interventional
215
19 countries
143
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2021
Shorter than P25 for phase_2
143 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 2020
CompletedFirst Posted
Study publicly available on registry
November 3, 2020
CompletedStudy Start
First participant enrolled
January 29, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 17, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 3, 2022
CompletedResults Posted
Study results publicly available
May 31, 2023
CompletedAugust 1, 2023
July 1, 2023
12 months
November 2, 2020
January 13, 2023
July 28, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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.
change from baseline to week 12
Secondary Outcomes (2)
Least Squares Mean (SE) Changes in Worst EAPP From Baseline to Week 12, Per Protocol Set
change from baseline to week 12
Number of Participants With Treatment-emergent Adverse Events (TEAE)
up to 14 days after the last study medication intake
Study Arms (5)
BAY1817080 150 mg
EXPERIMENTALParticipants will receive 150 mg of BAY1817080 twice daily over a 12-week intervention period
BAY1817080 75 mg
EXPERIMENTALParticipants will receive 75 mg of BAY1817080 twice daily over a 12-week intervention period
BAY1817080 25 mg
EXPERIMENTALParticipants will receive 25 mg of BAY1817080 twice daily over a 12-week intervention period
Elagolix
ACTIVE COMPARATORParticipants will receive 150 mg of Elagolix once daily over a 12-week intervention period
Placebo
PLACEBO COMPARATORParticipants will receive placebo matching BAY1817080 twice daily over a 12-week intervention period
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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)
- 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
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (147)
Accel Research Sites - Cahaba Medical Care
Birmingham, Alabama, 35218, United States
University of Alabama at Birmingham
Birmingham, Alabama, 35294-0026, United States
Mobile Ob-Gyn, PC
Mobile, Alabama, 36608-6703, United States
Precision Trials, AZ, LLC
Phoenix, Arizona, 85032, United States
Diagnamics, Inc.
Encinitas, California, 92024, United States
West Coast OB/GYN Associates
San Diego, California, 92123, United States
Advanced Women's Health Institute
Greenwood Village, Colorado, 80111, United States
Office of Dr. James A. Simon, MD
Washington D.C., District of Columbia, 20036, United States
Helix Biomedics, LLC
Boynton Beach, Florida, 33435, United States
Alliance for Multispecialty Research, LLC - Fort Meyers
Fort Myers, Florida, 33912, United States
Suncoast Clinical Research Center, Inc.
New Port Richey, Florida, 34652, United States
A Premier Medical Research of Florida, LLC
Orange City, Florida, 32763, United States
Physician Care Clinical Research
Sarasota, Florida, 34239, United States
Medisense, Inc.
Atlanta, Georgia, 30363, United States
Augusta University Medical Center
Augusta, Georgia, 30912, United States
Paramount Research Solutions-College Park
College Park, Georgia, 30349, United States
Journey Medical Research
Snellville, Georgia, 30078, United States
Clinical Research Prime
Idaho Falls, Idaho, 83404, United States
Southern Clinical Research Associates LLC
Metairie, Louisiana, 70001, United States
Continental Clinical Solutions, LLC
Towson, Maryland, 21204, United States
Wayne State University Physicians Group
Detroit, Michigan, 48201, United States
Essential Women's Health Associates
Las Vegas, Nevada, 89113, United States
Bosque Womens Care
Albuquerque, New Mexico, 87109, United States
SUNY Downstate Medical Center
Brooklyn, New York, 11203, United States
Carolina Women's Research & Wellness Center
Durham, North Carolina, 27713, United States
Lyndhurst Clinical Research
Winston-Salem, North Carolina, 27103, United States
Clinical Inquest Center, Ltd.
Beavercreek, Ohio, 45432, United States
Aventiv Research - Dublin
Dublin, Ohio, 43016, United States
Centricity Research formerly Aventiv - Dublin
Dublin, Ohio, 43016, United States
HWC Women's Research Center
Englewood, Ohio, 45322, United States
University Hospitals Landerbrook Health Center
Mayfield Heights, Ohio, 44124, United States
Palmetto Clinical Research
Summerville, South Carolina, 29485, United States
Chattanooga Medical Research, LLC
Chattanooga, Tennessee, 37404, United States
ClinSearch, LLC
Chattanooga, Tennessee, 37421, United States
Medical Research Center of Memphis, LLC
Memphis, Tennessee, 38120, United States
International Clinical Research-Tennessee LLC.
Murfreesboro, Tennessee, 37130, United States
Discovery Clinical Trials - Dallas
Dallas, Texas, 75230, United States
UT Health Women's Research Center at Memorial City
Houston, Texas, 77024, United States
Biopharma Informatic, Inc.
Houston, Texas, 77043, United States
Centex Studies, Inc.
Houston, Texas, 77058, United States
Centex Studies, Inc.
Houston, Texas, 77090, United States
Advances in Health
Pearland, Texas, 77584, United States
Tidewater Clinical Research, Inc.
Norfolk, Virginia, 23456, United States
Eastern Virginia Medical School | OB/GYN Clinical Research Center
Norfolk, Virginia, 23507, United States
Eastern Virginia Medical School
Norfolk, Virginia, 23507, United States
Virginia Physicians For Women
North Chesterfield, Virginia, 23235, United States
Seattle Clinical Research Center
Seattle, Washington, 98105, United States
Medizinische Universität Graz
Graz, Styria, 8036, Austria
Universitätsklinikum AKH Wien
Vienna, 1090, Austria
AZ Jan Palfijn Gent
Ghent, Oost-Vlaanderen, 9000, Belgium
CU Saint-Luc/UZ St-Luc
Bruxelles - Brussel, 1200, Belgium
Ziekenhuis Oost-Limburg
Genk, 3600, Belgium
UZ Gent
Ghent, 9000, Belgium
MC Asklepii OOD
Dupnitsa, 2600, Bulgaria
Spec. Hospital for Active Treatment of Oncological Diseases
Sofia, 1233, Bulgaria
Medical Center Panaceya
Sofia, 1606, Bulgaria
MHAT Niamed
Stara Zagora, 6000, Bulgaria
SHOGAT Prof Dimitar Stamatov
Varna, 9000, Bulgaria
The Ottawa Hospital
Ottawa, Ontario, K1H 7W9, Canada
The Ottawa Hospital | The Ottawa Hospital Research Institute - Neurology - Ottawa Stroke Program
Ottawa, Ontario, K1Y4E9, Canada
The Ottawa Hospital
Ottawa, Ontario, K1Y4E9, Canada
Clinique OVO
Montreal, Quebec, H4P 2S4, Canada
Alpha Recherche Clinique LB9
Québec, G2J 0C4, Canada
First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510120, China
Guangzhou Women and Children's Medical Center
Guangzhou, Guangdong, 510623, China
Wuhan Tongji Reproductive Medicine Hospital
Wuhan, Hubei, 430013, China
The Second Affiliated Hospital of Nanjing Medical university
Nanjing, Jiangsu, 210000, China
The Second Affiliated Hospital of Nanjing Medical university
Nanjing, Jiangsu, 210011, China
Women's Hospital School of Medicine Zhejiang University
Hangzhou, Zhejiang, 310006, China
Beijing Obstetrics and Gynecology Hospital,Capital Med.Uni.
Beijing, 100026, China
Peking University First Hospital
Beijing, 100034, China
Fakultni nemocnice Brno
Brno, 625 00, Czechia
Gynekologie Meda s.r.o. - Lidicka
Brno-střed, 60200, Czechia
GYN-MIKA s.r.o.
České Budějovice, 370 01, Czechia
GynCare MUDr. Michael Svec s.r.o.
Pilsen, 326 00, Czechia
Centrum gynekologicke rehabilitace
Písek, 39701, Czechia
GYNERA
Prague, 156 00, Czechia
Gynekologie Studentsky dum s.r.o.
Prague, 160 00, Czechia
Fakultní nemocnice Bulovka
Prague, 180 81, Czechia
Dr. Smrhova-Kovacs
Tábor, 39003, Czechia
Parnu Hospital
Pärnu, 80010, Estonia
Clinic Elite
Tartu, 50407, Estonia
HUS / Naistenklinikka
Helsinki, 00029, Finland
Lääkärikeskus Gyneko
Oulu, 90100, Finland
Universitätsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg, 69120, Germany
Praxisklinik am Rosengarten
Mannheim, Baden-Wurttemberg, 68165, Germany
Praxis f. Gynäkologie und Geburtshilfe
Bernburg, Saxony-Anhalt, 06406, Germany
emovis GmbH
Berlin, 10629, Germany
Charité - Campus Virchow-Klinikum (CVK)
Berlin, 13353, Germany
ARETAIEION University Hospital
Athens, 11528, Greece
University General Hospital of Patras | Univ Obs & Gynae Cli
Pátrai, 26504, Greece
Cortex Study Center
Budapest, 1026, Hungary
SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont
Szeged, 6725, Hungary
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Lazio, 00168, Italy
IRCCS Ospedale Policlinico San Martino
Genoa, Liguria, 16132, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Lombardy, 20122, Italy
ASST Sette Laghi
Varese, Lombardy, 21100, Italy
A.O.U. Careggi
Florence, Tuscany, 50134, Italy
A.O.U.I. Verona
Verona, Veneto, 37126, Italy
Aiiku Ladies Clinic
Funabashi, Chiba, 274-0071, Japan
Tokyo Bay Urayasu Ichikawa Medical Center
Urayasu, Chiba, 279-0001, Japan
Sou Clinic
Yotsukaidō, Chiba, 284-0001, Japan
Teine Keijinkai Hospital
Sapporo, Hokkaido, 006-8555, Japan
Social Medical Corporation Tokeidai Memorial Hospital
Sapporo, Hokkaido, 060-0031, Japan
Nishikawa Women's Health Clinic
Sapporo, Hokkaido, 060-0061, Japan
Hitachi General Hospital
Hitachi, Ibaraki, 317-0077, Japan
Ibaraki Prefectural Central Hospital
Kasama, Ibaraki, 309-1793, Japan
Fujisawa City Hospital
Fujisawa, Kanagawa, 251-8550, Japan
Yokosuka Kyosai Hospital
Yokosuka, Kanagawa, 238-8558, Japan
Kurashiki Medical Clinic
Kurashiki, Okayama-ken, 710-0824, Japan
Suita Tokushukai Hospital
Suita, Osaka, 565-0814, Japan
Omi Medical Center
Kusatsu, Shiga, 525-8585, Japan
Kashiwazaki ladies clinic
Saitama, Tokyo, 330-0855, Japan
NTT Medical Center Tokyo
Shinagawa-ku, Tokyo, 141-8625, Japan
Toyama Rosai Hospital
Uozu, Toyama, 937-0042, Japan
JCHO Tokuyama Central Hospital
Shūnan, Yamaguchi, 745-8522, Japan
Japanese Red Cross Kumamoto Hospital
Kumamoto, 861-8520, Japan
Saiseikai Nagasaki Hospital
Nagasaki, 850-0003, Japan
Nagasaki University Hospital
Nagasaki, 852-8501, Japan
Latvian Maritime Medicine Center
Riga, LV-1005, Latvia
Vitols and Vitols Ltd
Riga, LV-1006, Latvia
I.Vasaraudzes Private Practice
Riga, LV-1011, Latvia
I.Dinsbergas Physician Practice
Riga, LV-1013, Latvia
JSC Seimos gydytojas family medical center
Vilnius, LT-01118, Lithuania
V. Jonaitienes private gynecology clinic
Vilnius, LT-01123, Lithuania
JSC Gyvenk Silciau Medical Center Maxmeda
Vilnius, LT-03225, Lithuania
Kirkeparken Spesialistpraksis
Fredrikstad, 1605, Norway
Oslo Universitetssykehus HF, Ullevål
Oslo, 0450, Norway
Sykehuset i Vestfold HF, Tønsberg
Tønsberg, 3116, Norway
Gabinet Ginekologiczny Janusz Tomaszewski
Bialystok, 15-244, Poland
MICS Centrum Medyczne Torun
Bydgoszcz, 85-065, Poland
CLINICAL MEDICAL RESEARCH Sp. z o. o.
Katowice, 40-156, Poland
NZOZ MEDEM Wilk Sp. j.
Katowice, 40-301, Poland
Vita Longa Sp. z o.o.
Katowice, 40-748, Poland
Prywatny Gabinet Lekarski Ginekologia, Poloznictwo i Ultr.
Lodz, 90-602, Poland
Specjalistyczny Gabinet Ginekologiczno-Polozniczy
Lublin, 20-400, Poland
NZOZ NOVITA, Specjalistyczne Gabinety Lekarskie S.C
Lublin, 20-632, Poland
VitroLive Sp. z o.o.
Szczecin, 70-483, Poland
MTZ Clinical Research Sp z o.o.
Warsaw, 02-106, Poland
Medical Concierge Centrum Medyczne
Warsaw, 02-798, Poland
ULMUS, s r.o.
Hlohovec, 920 01, Slovakia
GA Lucenec s.r.o
Lučenec, 984 01, Slovakia
Virina sano, s.r.o. Gynekologicko porodnicka ambulancia
Veľký Krtíš, 990 01, Slovakia
Hospital de Basurto
Bilbao, Vizcaya, 48013, Spain
Hospital de la Santa Creu i de Sant Pau | Ginecologia
Barcelona, 08041, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital General Universitario de Valencia
Valencia, 46014, Spain
Related Publications (2)
Parke S, Gude K, Roth K, Messina F. Efficacy and safety of eliapixant in endometriosis-associated pelvic pain: the randomized, placebo-controlled phase 2b SCHUMANN study. BMC Womens Health. 2024 Jun 19;24(1):353. doi: 10.1186/s12905-024-03188-8.
PMID: 38890641DERIVEDFletcher MC. Selectivity of the P2X3 receptor antagonist Eliapixant, and its potential use in the treatment of endometriosis. Purinergic Signal. 2022 Mar;18(1):1-3. doi: 10.1007/s11302-021-09831-5. Epub 2022 Jan 3. No abstract available.
PMID: 34978027DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- Bayer AG
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Double blind to placebo and open-label for active comparator
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 2020
First Posted
November 3, 2020
Study Start
January 29, 2021
Primary Completion
January 17, 2022
Study Completion
May 3, 2022
Last Updated
August 1, 2023
Results First Posted
May 31, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share
Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.