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

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

Study Overview

• Status: Terminated
• Conditions: Endometriosis
• Intervention / Treatment: Drug: BAY1817080; Drug: Elagolix; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 215
• Phase: Phase 2

Contacts and Locations

Study Locations

• Austria
  • Wien, Austria, 1090
    • Universitätsklinikum AKH Wien
  • Steiermark
    • Graz, Steiermark, Austria, 8036
      • Medizinische Universität Graz
• Belgium
  • Bruxelles - Brussel, Belgium, 1200
    • CU Saint-Luc/UZ St-Luc
  • Genk, Belgium, 3600
    • Ziekenhuis Oost-Limburg
  • Gent, Belgium, 9000
    • UZ Gent
  • Oost-Vlaanderen
    • Gent, Oost-Vlaanderen, Belgium, 9000
      • AZ Jan Palfijn Gent
• Bulgaria
  • Dupnitza, Bulgaria, 2600
    • MC Asklepii OOD
  • Sofia, Bulgaria, 1233
    • Spec. Hospital for Active Treatment of Oncological Diseases
  • Sofia, Bulgaria, 1606
    • Medical Center Panaceya
  • Stara Zagora, Bulgaria, 6000
    • MHAT Niamed
  • Varna, Bulgaria, 9000
    • SHOGAT Prof Dimitar Stamatov
• Canada
  • Quebec, Canada, G2J 0C4
    • Alpha Recherche Clinique LB9
  • Ontario
    • Ottawa, Ontario, Canada, K1H 7W9
      • The Ottawa Hospital
    • Ottawa, Ontario, Canada, K1Y4E9
      • The Ottawa Hospital
    • Ottawa, Ontario, Canada, K1Y4E9
      • The Ottawa Hospital | The Ottawa Hospital Research Institute - Neurology - Ottawa Stroke Program
  • Quebec
    • Montreal, Quebec, Canada, H4P 2S4
      • Clinique OVO
• China
  • Beijing, China, 100026
    • Beijing Obstetrics and Gynecology Hospital,Capital Med.Uni.
  • Beijing, China, 100034
    • Peking University first hospital
  • Guangdong
    • Guangzhou, Guangdong, China, 510623
      • Guangzhou Women And Children's Medical Center
    • Guangzhou, Guangdong, China, 510120
      • First Affiliated Hospital of Guangzhou Medical University
  • Hubei
    • Wuhan, Hubei, China, 430013
      • Wuhan Tongji Reproductive Medicine Hospital
  • Jiangsu
    • Nanjing, Jiangsu, China, 210011
      • The Second Affiliated Hospital of Nanjing Medical University
    • Nanjing, Jiangsu, China, 210000
      • The Second Affiliated Hospital of Nanjing Medical University
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310006
      • Women's Hospital School of Medicine Zhejiang University
• Czechia
  • Brno, Czechia, 625 00
    • Fakultni nemocnice Brno
  • Brno - stred, Czechia, 60200
    • Gynekologie Meda s.r.o. - Lidicka
  • Ceske Budejovice, Czechia, 370 01
    • GYN-MIKA s.r.o.
  • Pisek, Czechia, 39701
    • Centrum gynekologicke rehabilitace
  • Plzen, Czechia, 326 00
    • Gyncare MUDr. Michael Švec s.r.o.
  • Praha 5, Czechia, 156 00
    • GYNERA
  • Praha 6, Czechia, 160 00
    • Gynekologie Studentsky dum s.r.o.
  • Praha 8, Czechia, 180 81
    • Fakultni nemocnice Bulovka
  • Tabor, Czechia, 39003
    • Dr. Smrhova-Kovacs
• Estonia
  • Parnu, Estonia, 80010
    • Parnu Hospital
  • Tartu, Estonia, 50407
    • Clinic Elite
• Finland
  • Helsinki, Finland, 00029
    • HUS / Naistenklinikka
  • Oulu, Finland, 90100
    • Lääkärikeskus Gyneko
• Germany
  • Berlin, Germany, 13353
    • Charite - Campus Virchow-Klinikum (CVK)
  • Berlin, Germany, 10629
    • emovis GmbH
  • Baden-Württemberg
    • Heidelberg, Baden-Württemberg, Germany, 69120
      • Universitätsklinikum Heidelberg
    • Mannheim, Baden-Württemberg, Germany, 68165
      • Praxisklinik am Rosengarten
  • Sachsen-Anhalt
    • Bernburg, Sachsen-Anhalt, Germany, 06406
      • Praxis f. Gynäkologie und Geburtshilfe
• Greece
  • Athens, Greece, 11528
    • Aretaieion University Hospital
  • Patra, Greece, 26504
    • University General Hospital of Patras | Univ Obs & Gynae Cli
• Hungary
  • Budapest, Hungary, 1026
    • Cortex Study Center
  • Szeged, Hungary, 6725
    • SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont
• Italy
  • Lazio
    • Roma, Lazio, Italy, 00168
      • Fondazione Policlinico Universitario Agostino Gemelli Irccs
  • Liguria
    • Genova, Liguria, Italy, 16132
      • IRCCS Ospedale Policlinico San Martino
  • Lombardia
    • Milano, Lombardia, Italy, 20122
      • Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico
    • Varese, Lombardia, Italy, 21100
      • ASST Sette Laghi
  • Toscana
    • Firenze, Toscana, Italy, 50134
      • A.O.U. Careggi
  • Veneto
    • Verona, Veneto, Italy, 37126
      • A.O.U.I. Verona
• Japan
  • Kumamoto, Japan, 861-8520
    • Japanese Red Cross Kumamoto Hospital
  • Nagasaki, Japan, 852-8501
    • Nagasaki University Hospital
  • Nagasaki, Japan, 850-0003
    • Saiseikai Nagasaki Hospital
  • Chiba
    • Funabashi, Chiba, Japan, 274-0071
      • Aiiku Ladies Clinic
    • Urayasu, Chiba, Japan, 279-0001
      • Tokyo Bay Urayasu Ichikawa Medical Center
    • Yotsukaido, Chiba, Japan, 284-0001
      • Sou Clinic
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 006-8555
      • Teine Keijinkai Hospital
    • Sapporo, Hokkaido, Japan, 060-0031
      • Social Medical Corporation Tokeidai Memorial Hospital
    • Sapporo, Hokkaido, Japan, 060-0061
      • NISHIKAWA Women's Health Clinic
  • Ibaraki
    • Hitachi, Ibaraki, Japan, 317-0077
      • Hitachi General Hospital
    • Kasama, Ibaraki, Japan, 309-1793
      • Ibaraki Prefectural Central Hospital
  • Kanagawa
    • Fujisawa, Kanagawa, Japan, 251-8550
      • Fujisawa City Hospital
    • Yokosuka, Kanagawa, Japan, 238-8558
      • Yokosuka Kyosai Hospital
  • Okayama
    • Kurashiki, Okayama, Japan, 710-0824
      • Kurashiki Medical Clinic
  • Osaka
    • Suita, Osaka, Japan, 565-0814
      • Suita Tokushukai Hospital
  • Shiga
    • Kusatsu, Shiga, Japan, 525-8585
      • Omi Medical Center
  • Tokyo
    • Saitama, Tokyo, Japan, 330-0855
      • Kashiwazaki ladies clinic
    • Shinagawa-ku, Tokyo, Japan, 141-8625
      • Ntt Medical Center Tokyo
  • Toyama
    • Uozu, Toyama, Japan, 937-0042
      • Toyama Rosai Hospital
  • Yamaguchi
    • Shunan, Yamaguchi, Japan, 745-8522
      • JCHO Tokuyama Central Hospital
• Latvia
  • Riga, Latvia, LV-1005
    • Latvian Maritime Medicine Center
  • Riga, Latvia, LV-1006
    • Vitols and Vitols Ltd
  • Riga, Latvia, LV-1011
    • I.Vasaraudzes Private Practice
  • Riga, Latvia, LV-1013
    • I.Dinsbergas Physician Practice
• Lithuania
  • Vilnius, Lithuania, LT-01118
    • JSC Seimos gydytojas family medical center
  • Vilnius, Lithuania, LT-01123
    • V. Jonaitienes private gynecology clinic
  • Vilnius, Lithuania, LT-03225
    • JSC Gyvenk Silciau Medical Center Maxmeda
• Norway
  • Fredrikstad, Norway, 1605
    • Kirkeparken Spesialistpraksis
  • Oslo, Norway, 0450
    • Oslo Universitetssykehus HF, Ullevål
  • Tønsberg, Norway, 3116
    • Sykehuset i Vestfold HF, Tønsberg
• Poland
  • Bialystok, Poland, 15-244
    • Gabinet Ginekologiczny Janusz Tomaszewski
  • Bydgoszcz, Poland, 85-065
    • MICS Centrum Medyczne Torun
  • Katowice, Poland, 40-156
    • CLINICAL MEDICAL RESEARCH Sp. z o. o.
  • Katowice, Poland, 40-748
    • Vita Longa Sp. z o.o.
  • Katowice, Poland, 40-301
    • NZOZ MEDEM Wilk Sp. j.
  • Lodz, Poland, 90-602
    • Prywatny Gabinet Lekarski Ginekologia, Poloznictwo i Ultr.
  • Lublin, Poland, 20-400
    • Specjalistyczny Gabinet Ginekologiczno-Polozniczy
  • Lublin, Poland, 20-632
    • NZOZ NOVITA, Specjalistyczne Gabinety Lekarskie S.C
  • Szczecin, Poland, 70-483
    • VitroLive Sp. z o.o.
  • Warszawa, Poland, 02-798
    • Medical Concierge Centrum Medyczne
  • Warszawa, Poland, 02-106
    • MTZ Clinical Research Sp z o.o.
• Slovakia
  • Hlohovec, Slovakia, 920 01
    • ULMUS, s r.o.
  • Lucenec, Slovakia, 984 01
    • GA Lucenec s.r.o
  • Velky Krtis, Slovakia, 990 01
    • Virina sano, s.r.o. Gynekologicko porodnicka ambulancia
• Spain
  • Barcelona, Spain, 08041
    • Hospital de la Santa Creu i de Sant Pau | Ginecologia
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de octubre
  • Valencia, Spain, 46014
    • Hospital General Universitario de Valencia
  • Vizcaya
    • Bilbao, Vizcaya, Spain, 48013
      • Hospital de Basurto
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35218
      • Accel Research Sites - Cahaba Medical Care
    • Birmingham, Alabama, United States, 35294-0026
      • University of Alabama at Birmingham
    • Mobile, Alabama, United States, 36608-6703
      • Mobile Ob-Gyn, PC
  • Arizona
    • Phoenix, Arizona, United States, 85032
      • Precision Trials, AZ, LLC
  • California
    • Encinitas, California, United States, 92024
      • Diagnamics, Inc.
    • San Diego, California, United States, 92123
      • West Coast OB/GYN Associates
  • Colorado
    • Greenwood Village, Colorado, United States, 80111
      • Advanced Women's Health Institute
  • District of Columbia
    • Washington, District of Columbia, United States, 20036
      • Office of Dr. James A. Simon, MD
  • Florida
    • Boynton Beach, Florida, United States, 33435
      • Helix Biomedics, LLC
    • Fort Myers, Florida, United States, 33912
      • Alliance for Multispecialty Research, LLC - Fort Meyers
    • New Port Richey, Florida, United States, 34652
      • Suncoast Clinical Research Center, Inc.
    • Orange City, Florida, United States, 32763
      • A Premier Medical Research of Florida, LLC
    • Sarasota, Florida, United States, 34239
      • Physician Care Clinical Research
  • Georgia
    • Atlanta, Georgia, United States, 30363
      • Medisense, Inc.
    • Augusta, Georgia, United States, 30912
      • Augusta University Medical Center
    • College Park, Georgia, United States, 30349
      • Paramount Research Solutions-College Park
    • Snellville, Georgia, United States, 30078
      • Journey Medical Research
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Clinical Research Prime
  • Louisiana
    • Metairie, Louisiana, United States, 70001
      • Southern Clinical Research Associates LLC
  • Maryland
    • Towson, Maryland, United States, 21204
      • Continental Clinical Solutions, LLC
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Wayne State University Physicians Group
  • Nevada
    • Las Vegas, Nevada, United States, 89113
      • Essential Women's Health Associates
  • New Mexico
    • Albuquerque, New Mexico, United States, 87109
      • Bosque Womens Care
  • New York
    • Brooklyn, New York, United States, 11203
      • SUNY downstate Medical Center
  • North Carolina
    • Durham, North Carolina, United States, 27713
      • Carolina Women's Research & Wellness Center
    • Winston-Salem, North Carolina, United States, 27103
      • Lyndhurst Clinical Research
  • Ohio
    • Beavercreek, Ohio, United States, 45432
      • Clinical Inquest Center, Ltd.
    • Dublin, Ohio, United States, 43016
      • Aventiv Research - Dublin
    • Dublin, Ohio, United States, 43016
      • Centricity Research formerly Aventiv - Dublin
    • Englewood, Ohio, United States, 45322
      • HWC Women's Research Center
    • Mayfield Heights, Ohio, United States, 44124
      • University Hospitals Landerbrook Health Center
  • South Carolina
    • Summerville, South Carolina, United States, 29485
      • Palmetto Clinical Research
  • Tennessee
    • Chattanooga, Tennessee, United States, 37421
      • ClinSearch, LLC
    • Chattanooga, Tennessee, United States, 37404
      • Chattanooga Medical Research, Llc
    • Memphis, Tennessee, United States, 38120
      • Medical Research Center of Memphis, LLC
    • Murfreesboro, Tennessee, United States, 37130
      • International Clinical Research-Tennessee LLC.
  • Texas
    • Dallas, Texas, United States, 75230
      • Discovery Clinical Trials - Dallas
    • Houston, Texas, United States, 77058
      • Centex Studies, Inc.
    • Houston, Texas, United States, 77024
      • UT Health Women's Research Center at Memorial City
    • Houston, Texas, United States, 77090
      • Centex Studies, Inc.
    • Houston, Texas, United States, 77043
      • Biopharma Informatic, Inc.
    • Pearland, Texas, United States, 77584
      • Advances In Health
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Eastern Virginia Medical School
    • Norfolk, Virginia, United States, 23456
      • Tidewater Clinical Research, Inc.
    • Norfolk, Virginia, United States, 23507
      • Eastern Virginia Medical School | OB/GYN Clinical Research Center
    • North Chesterfield, Virginia, United States, 23235
      • Virginia Physicians For Women
  • Washington
    • Seattle, Washington, United States, 98105
      • Seattle Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BAY1817080 150 mg; Participants will receive 150 mg of BAY1817080 twice daily over a 12-week intervention period	Drug: BAY1817080; Tablet, oral administration
Experimental: BAY1817080 75 mg; Participants will receive 75 mg of BAY1817080 twice daily over a 12-week intervention period	Drug: BAY1817080; Tablet, oral administration
Experimental: BAY1817080 25 mg; Participants will receive 25 mg of BAY1817080 twice daily over a 12-week intervention period	Drug: BAY1817080; Tablet, oral administration
Active Comparator: Elagolix; Participants will receive 150 mg of Elagolix once daily over a 12-week intervention period	Drug: Elagolix; Tablet, oral administration
Placebo Comparator: Placebo; Participants will receive placebo matching BAY1817080 twice daily over a 12-week intervention period	Drug: Placebo; Tablet, oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Least Squares Mean (SE) Changes in Worst EAPP From Baseline to Week 12, Per Protocol Set	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
Number of Participants With Treatment-emergent Adverse Events (TEAE)	A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	up to 14 days after the last study medication intake

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

General Publications

• Fletcher 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.

Helpful Links

• Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.
• Click here to find information about studies related to Bayer Healthcare products conducted in Europe.

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2021
• Primary Completion (Actual): January 17, 2022
• Study Completion (Actual): May 3, 2022

Study Registration Dates

• First Submitted: November 2, 2020
• First Submitted That Met QC Criteria: November 2, 2020
• First Posted (Actual): November 3, 2020

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 28, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Endometriosis
• Other Study ID Numbers: 20584; 2020-003131-16 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No