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:

NCT04614246

EudraCT Number:

2020-003131-16

Study Completed

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
194
Trial Dates
black-arrow
Phase
2
Could I receive a placebo?
Yes
Products
Eliapixant (BAY1817080)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Oslo Universitetssykehus HF, Ullevål

Oslo, Norway, 0450

Status
Completed
 
Locations

Kirkeparken Spesialistpraksis

Fredrikstad, Norway, 1605

Status
Completed
 
Locations

ULMUS, s r.o.    

Hlohovec, Slovakia, 920 01

Status
Completed
 
Locations

A.O.U.I. Verona

Verona, Italy, 37126

Status
Completed
 
Locations

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milano, Italy, 20122

Status
Completed
 
Locations

A.O.U. Careggi

Firenze, Italy, 50134

Status
Completed
 
Locations

IRCCS Ospedale Policlinico San Martino

Genova, Italy, 16132

Status
Completed
 
Locations

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, Italy, 00168

Status
Completed
 
Locations

ASST Sette Laghi

Varese, Italy, 21100

Status
Completed
 
Locations

Universitätsklinikum AKH Wien

Wien, Austria, 1090

Status
Completed
 
Locations

Universitätsklinikum AKH Wien

Wien, Austria, 1090

Status
Completed
 
Locations

Medizinische Universität Graz

Graz, Austria, 8036

Status
Completed
 
Locations

Fakultni nemocnice Brno

Brno, Czech Republic, 625 00

Status
Completed
 
Locations

Gynekologie Meda s.r.o. - Lidicka

Brno - stred, Czech Republic, 60200

Status
Completed
 
Locations

Fakultní nemocnice Bulovka

Praha 8, Czech Republic, 180 81

Status
Completed
 
Locations

Dr. Smrhova-Kovacs

Tabor, Czech Republic, 39003

Status
Completed
 
Locations

GynCare MUDr. Michael Svec s.r.o.

Plzen, Czech Republic, 326 00

Status
Completed
 
Locations

GYN-MIKA s.r.o.

Ceske Budejovice, Czech Republic, 370 01

Status
Completed
 
Locations

Gynekologie Studentsky dum s.r.o.

Praha 6, Czech Republic, 160 00

Status
Completed
 
Locations

Centrum gynekologicke rehabilitace

Pisek, Czech Republic, 39701

Status
Completed
 
Locations

GYNERA

Praha 5, Czech Republic, 156 00

Status
Completed
 
Locations

GA Lucenec s.r.o

Lucenec, Slovakia, 984 01

Status
Completed
 
Locations

Virina sano, s.r.o. Gynekologicko porodnicka ambulancia

Velky Krtis, Slovakia, 990 01

Status
Completed
 
Locations

Hospital de la Santa Creu i de Sant Pau

Barcelona, Spain, 08025

Status
Completed
 
Locations

Hospital Universitario 12 de Octubre

Madrid, Spain, 28041

Status
Completed
 
Locations

Hospital de Basurto

Bilbao, Spain, 48013

Status
Completed
 
Locations

Hospital General Universitario de Valencia

Valencia, Spain, 46014

Status
Completed
 
Locations

NZOZ NOVITA, Specjalistyczne Gabinety Lekarskie S.C

Lublin, Poland, 20-632

Status
Completed
 
Locations

Specjalistyczny Gabinet Ginekologiczno-Polozniczy

Lublin, Poland, 20-400

Status
Completed
 
Locations

CLINICAL MEDICAL RESEARCH Sp. z o. o.

Katowice, Poland, 40-156

Status
Completed
 
Locations

Vita Longa Sp. z o.o.

Katowice, Poland, 40-748

Status
Completed
 
Locations

MICS Centrum Medyczne Torun

Bydgoszcz, Poland, 85-065

Status
Completed
 
Locations

Gabinet Ginekologiczny Janusz Tomaszewski

Bialystok, Poland, 15-244

Status
Completed
 
Locations

Indywidualna Specjalistyczna Praktyka Lek Krzysztof Wilk

Katowice, Poland, 40-301

Status
Completed
 
Locations

MTZ Clinical Research Sp z o.o.

Warszawa, Poland, 02-106

Status
Completed
 
Locations

Prywatny Gabinet Lekarski Ginekologia, Poloznictwo i Ultr.

Lodz, Poland, 90-602

Status
Completed
 
Locations

VitroLive Sp. z o.o.

Szczecin, Poland, 70-483

Status
Completed
 
Locations

Medical Concierge Centrum Medyczne

Warszawa, Poland, 02-798

Status
Completed
 
Locations

Clinic Elite

Tartu, Estonia, 50407

Status
Completed
 
Locations

Parnu Hospital

Parnu, Estonia, 80010

Status
Completed
 
Locations

The Ottawa Hospital

Ottawa, Canada, K1H 7W9

Status
Completed
 
Locations

Clinique OVO

Montreal, Canada, H4P 2S4

Status
Completed
 
Locations

Alpha Recherche Clinique LB9

Quebec, Canada, G2J 0C4

Status
Completed
 
Locations

JSC Seimos gydytojas family medical center

Vilnius, Lithuania, LT-01118

Status
Completed
 
Locations

JSC Gyvenk Silciau Medical Center Maxmeda

Vilnius, Lithuania, LT-03225

Status
Completed
 
Locations

MHAT Niamed

Stara Zagora, Bulgaria, 6000

Status
Completed
 
Locations

MC Asklepii OOD

Dupnitza, Bulgaria, 2600

Status
Completed
 
Locations

Medical Center Panaceya

Sofia, Bulgaria, 1606

Status
Completed
 
Locations

Spec. Hospital for Active Treatment of Oncological Diseases

Sofia, Bulgaria, 1233

Status
Completed
 
Locations

Praxis f. Gynäkologie und Geburtshilfe

Bernburg, Germany, 06406

Status
Completed
 
Locations

Praxisklinik am Rosengarten

Mannheim, Germany, 68165

Status
Completed
 
Locations

Charité - Campus Virchow-Klinikum (CVK)

Berlin, Germany, 13353

Status
Completed
 
Locations

emovis GmbH

Berlin, Germany, 10629

Status
Completed
 
Locations

Universitätsklinikum Heidelberg

Heidelberg, Germany, 69120

Status
Completed
 
Locations

HUS / Naistenklinikka

Helsinki, Finland, 00029

Status
Completed
 
Locations

I.Vasaraudzes Private Practice

Riga, Latvia, LV-1011

Status
Completed
 
Locations

Vitols and Vitols Ltd

Riga, Latvia, LV-1006

Status
Completed
 
Locations

AZ Jan Palfijn Gent

Gent, Belgium, 9000

Status
Completed
 
Locations

Social Medical Corporation Tokeidai Memorial Hospital

Sapporo, Japan, 060-0031

Status
Completed
 
Locations

Teine Keijinkai Hospital

Sapporo, Japan, 006-8555

Status
Completed
 
Locations

Nishikawa Women's Health Clinic

Sapporo, Japan, 060-0061

Status
Completed
 
Locations

Aiiku Ladies Clinic

Funabashi, Japan, 274-0071

Status
Completed
 
Locations

Tokyo Bay Urayasu Ichikawa Medical Center

Urayasu, Japan, 279-0001

Status
Completed
 
Locations

NTT Medical Center Tokyo

Shinagawa-ku, Japan, 141-8625

Status
Completed
 
Locations

Fujisawa City Hospital

Fujisawa, Japan, 251-8550

Status
Completed
 
Locations

Kashiwazaki ladies clinic

Saitama, Japan, 330-0855

Status
Completed
 
Locations

Ibaraki Prefectural Central Hospital

Kasama, Japan, 309-1793

Status
Completed
 
Locations

Hitachi General Hospital

Hitachi, Japan, 317-0077

Status
Completed
 
Locations

Toyama Rosai Hospital

Uozu, Japan, 937-0042

Status
Completed
 
Locations

OMI MEDICAL CENTER

Kusatsu, Japan, 525-8585

Status
Completed
 
Locations

Suita Tokushukai Hospital

Suita, Japan, 565-0814

Status
Completed
 
Locations

Kurashiki Medical Clinic

Kurashiki, Japan, 710-0824

Status
Completed
 
Locations

JCHO Tokuyama Central Hospital

Shunan, Japan, 745-8522

Status
Completed
 
Locations

Saiseikai Nagasaki Hospital

Nagasaki, Japan, 850-0003

Status
Completed
 
Locations

CU Saint-Luc/UZ St-Luc

BRUXELLES - BRUSSEL, Belgium, 1200

Status
Completed
 
Locations

Ziekenhuis Oost-Limburg

GENK, Belgium, 3600

Status
Completed
 
Locations

UZ Gent

GENT, Belgium, 9000

Status
Completed
 
Locations

Cortex Study Center

Budapest, Hungary, 1026

Status
Completed
 
Locations

Peking University First Hospital

Beijing, China, 100034

Status
Completed
 
Locations

Wuhan Tongji Reproductive Medicine Hospital

Wuhan, China, 430013

Status
Completed
 
Locations

First Affiliated Hospital of Guangzhou Medical University

Guangzhou, China, 510120

Status
Completed
 
Locations

Guangzhou Women and Children's Medical Center

Guangzhou, China, 510623

Status
Completed
 
Locations

Women's Hospital School of Medicine Zhejiang University

Hangzhou, China, 310006

Status
Completed
 
Locations

The Second Affiliated Hospital of Nanjing Medical university

Nanjing, China, 210011

Status
Completed
 
Locations

Paramount Research Solutions-College Park

College Park, United States, 30349

Status
Completed
 
Locations

University of Alabama at Birmingham

Birmingham, United States, 35294-0026

Status
Completed
 
Locations

Southern Clinical Research Associates LLC

Metairie, United States, 70001

Status
Completed
 
Locations

A Premier Medical Research of Florida, LLC

Orange City, United States, 32763

Status
Terminated
 
Locations

Eastern Virginia Medical School

Norfolk, United States, 23507

Status
Completed
 
Locations

Aventiv Research - Dublin

Dublin, United States, 43016

Status
Completed
 
Locations

Journey Medical Research

Snellville, United States, 30078

Status
Completed
 
Locations

Carolina Women's Research & Wellness Center

Durham, United States, 27713

Status
Completed
 
Locations

Seattle Clinical Research Center

Seattle, United States, 98105

Status
Completed
 
Locations

Clinical Inquest Center, Ltd.

Beavercreek, United States, 45432

Status
Completed
 
Locations

UT Health Women’s Research Center at Memorial City

Houston, United States, 77024

Status
Completed
 
Locations

University Hospitals Landerbrook Health Center

Mayfield Heights, United States, 44124

Status
Completed
 
Locations

SUNY Downstate Medical Center

Brooklyn, United States, 11203

Status
Completed
 
Locations

Chattanooga Medical Research, LLC

Chattanooga, United States, 37404

Status
Completed
 
Locations

Medisense, Inc.

Atlanta, United States, 30363

Status
Completed
 
Locations

Virginia Physicians For Women

North Chesterfield, United States, 23235

Status
Completed
 
Locations

Continental Clinical Solutions, LLC

Towson, United States, 21204

Status
Completed
 
Locations

Helix Biomedics, LLC

Boynton Beach, United States, 33435

Status
Completed
 
Locations

Diagnamics, Inc.

Encinitas, United States, 92024

Status
Completed
 
Locations

Lyndhurst Clinical Research

Winston-Salem, United States, 27103

Status
Completed
 
Locations

Advanced Women's Health Institute

Greenwood Village, United States, 80111

Status
Completed
 
Locations

Mobile Ob-Gyn, PC

Mobile, United States, 36608-6703

Status
Completed
 
Locations

Advances in Health

Pearland, United States, 77584

Status
Completed
 
Locations

Wayne State University Physicians Group

Detroit, United States, 48201

Status
Completed
 
Locations

Biopharma Informatic, Inc.

Houston, United States, 77043

Status
Completed
 
Locations

Office of Dr. James A. Simon, MD

Washington, United States, 20036

Status
Completed
 
Locations

Suncoast Clinical Research Center, Inc.

New Port Richey, United States, 34652

Status
Completed
 
Locations

Bosque Womens Care

Albuquerque, United States, 87109

Status
Completed
 
Locations

Physician Care Clinical Research

Sarasota, United States, 34239

Status
Not yet recruiting
 
Locations

HWC Women’s Research Center

Englewood, United States, 45322

Status
Completed
 
Locations

Augusta University Medical Center

Augusta, United States, 30912

Status
Completed
 
Locations

Medical Research Center of Memphis, LLC

Memphis, United States, 38120

Status
Completed
 
Locations

Palmetto Clinical Research

Summerville, United States, 29485

Status
Completed
 
Locations

Yokosuka Kyosai Hospital

Yokosuka, Japan, 238-8558

Status
Completed
 
Locations

Japanese Red Cross Kumamoto Hospital

Kumamoto, Japan, 861-8520

Status
Completed
 
Locations

ARETAIEION University Hospital

Athens, Greece, 11528

Status
Completed
 
Locations

University General Hospital of Patras | Univ Obs & Gynae Cli

Patra, Greece, 26504

Status
Completed
 
Locations

V. Jonaitienes private gynecology clinic

Vilnius, Lithuania, LT-01123

Status
Completed
 
Locations

ClinSearch, LLC

Chattanooga, United States, 37421

Status
Completed
 
Locations

International Clinical Research-Tennessee LLC.

Murfreesboro, United States, 37130

Status
Completed
 
Locations

Centex Studies, Inc.

Houston, United States, 77090

Status
Completed
 
Locations

Alliance for Multispecialty Research, LLC

Fort Myers, United States, 33912

Status
Completed
 
Locations

Accel Research Sites - Cahaba Medical Care

Birmingham, United States, 35218

Status
Completed
 
Locations

Discovery Clinical Trials

Dallas, United States, 75230

Status
Completed
 
Locations

West Coast OB/GYN Associates

San Diego, United States, 92123

Status
Completed
 
Locations

SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont

Szeged, Hungary, 6725

Status
Completed
 
Locations

I.Dinsbergas Physician Practice

Riga, Latvia, LV-1013

Status
Completed
 
Locations

Nagasaki University Hospital

Nagasaki, Japan, 852-8501

Status
Completed
 
Locations

Centex Studies, Inc.

Houston, United States, 77058

Status
Completed
 
Locations

Tidewater Clinical Research, Inc.

Norfolk, United States, 23456

Status
Completed
 
Locations

Clinical Research Prime

Idaho Falls, United States, 83404

Status
Completed
 
Locations

Precision Trials, AZ, LLC

Phoenix, United States, 85032

Status
Completed
 
Locations

Sykehuset i Vestfold HF, Tønsberg

Tønsberg, Norway, 3116

Status
Completed
 
Locations

Essential Women’s Health Associates

Las Vegas, United States, 89113

Status
Completed
 
Locations

Latvian Maritime Medicine Center

Riga, Latvia, LV-1005

Status
Completed
 
Locations

Beijing Obstetrics and Gynecology Hospital,Capital Med.Uni.

Beijing, China, 100026

Status
Completed
 
Locations

Lääkärikeskus Gyneko

Oulu, Finland, 90100

Status
Completed
 
Locations

Sou Clinic

Yotsukaido, Japan, 284-0001

Status
Completed
 
Locations

SHOGAT Prof Dimitar Stamatov

Varna, Bulgaria, 9000

Status
Completed
 

Trial Design