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

NCT ID: NCT04614246

Last Updated: 2023-08-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 215 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-29
• Study Completion Date: 2022-05-03

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

Conditions

Endometriosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

BAY1817080 150 mg

Participants will receive 150 mg of BAY1817080 twice daily over a 12-week intervention period

Group Type: EXPERIMENTAL

BAY1817080

Intervention Type: DRUG

Tablet, oral administration

BAY1817080 75 mg

Participants will receive 75 mg of BAY1817080 twice daily over a 12-week intervention period

Group Type: EXPERIMENTAL

BAY1817080

Intervention Type: DRUG

Tablet, oral administration

BAY1817080 25 mg

Participants will receive 25 mg of BAY1817080 twice daily over a 12-week intervention period

Group Type: EXPERIMENTAL

BAY1817080

Intervention Type: DRUG

Tablet, oral administration

Elagolix

Participants will receive 150 mg of Elagolix once daily over a 12-week intervention period

Group Type: ACTIVE_COMPARATOR

Elagolix

Intervention Type: DRUG

Tablet, oral administration

Placebo

Participants will receive placebo matching BAY1817080 twice daily over a 12-week intervention period

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Tablet, oral administration

Interventions

BAY1817080

Tablet, oral administration

Intervention Type: DRUG

Elagolix

Tablet, oral administration

Intervention Type: DRUG

Placebo

Tablet, oral administration

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Accel Research Sites - Cahaba Medical Care

Birmingham, Alabama, United States

University of Alabama at Birmingham

Birmingham, Alabama, United States

Mobile Ob-Gyn, PC

Mobile, Alabama, United States

Precision Trials, AZ, LLC

Phoenix, Arizona, United States

Diagnamics, Inc.

Encinitas, California, United States

West Coast OB/GYN Associates

San Diego, California, United States

Advanced Women's Health Institute

Greenwood Village, Colorado, United States

Office of Dr. James A. Simon, MD

Washington D.C., District of Columbia, United States

Helix Biomedics, LLC

Boynton Beach, Florida, United States

Alliance for Multispecialty Research, LLC - Fort Meyers

Fort Myers, Florida, United States

Suncoast Clinical Research Center, Inc.

New Port Richey, Florida, United States

A Premier Medical Research of Florida, LLC

Orange City, Florida, United States

Physician Care Clinical Research

Sarasota, Florida, United States

Medisense, Inc.

Atlanta, Georgia, United States

Augusta University Medical Center

Augusta, Georgia, United States

Paramount Research Solutions-College Park

College Park, Georgia, United States

Journey Medical Research

Snellville, Georgia, United States

Clinical Research Prime

Idaho Falls, Idaho, United States

Southern Clinical Research Associates LLC

Metairie, Louisiana, United States

Continental Clinical Solutions, LLC

Towson, Maryland, United States

Wayne State University Physicians Group

Detroit, Michigan, United States

Essential Women's Health Associates

Las Vegas, Nevada, United States

Bosque Womens Care

Albuquerque, New Mexico, United States

SUNY Downstate Medical Center

Brooklyn, New York, United States

Carolina Women's Research & Wellness Center

Durham, North Carolina, United States

Lyndhurst Clinical Research

Winston-Salem, North Carolina, United States

Clinical Inquest Center, Ltd.

Beavercreek, Ohio, United States

Aventiv Research - Dublin

Dublin, Ohio, United States

Centricity Research formerly Aventiv - Dublin

Dublin, Ohio, United States

HWC Women's Research Center

Englewood, Ohio, United States

University Hospitals Landerbrook Health Center

Mayfield Heights, Ohio, United States

Palmetto Clinical Research

Summerville, South Carolina, United States

Chattanooga Medical Research, LLC

Chattanooga, Tennessee, United States

ClinSearch, LLC

Chattanooga, Tennessee, United States

Medical Research Center of Memphis, LLC

Memphis, Tennessee, United States

International Clinical Research-Tennessee LLC.

Murfreesboro, Tennessee, United States

Discovery Clinical Trials - Dallas

Dallas, Texas, United States

UT Health Women's Research Center at Memorial City

Houston, Texas, United States

Biopharma Informatic, Inc.

Houston, Texas, United States

Centex Studies, Inc.

Houston, Texas, United States

Centex Studies, Inc.

Houston, Texas, United States

Advances in Health

Pearland, Texas, United States

Tidewater Clinical Research, Inc.

Norfolk, Virginia, United States

Eastern Virginia Medical School | OB/GYN Clinical Research Center

Norfolk, Virginia, United States

Eastern Virginia Medical School

Norfolk, Virginia, United States

Virginia Physicians For Women

North Chesterfield, Virginia, United States

Seattle Clinical Research Center

Seattle, Washington, United States

Medizinische Universität Graz

Graz, Styria, Austria

Universitätsklinikum AKH Wien

Vienna, , Austria

AZ Jan Palfijn Gent

Ghent, Oost-Vlaanderen, Belgium

CU Saint-Luc/UZ St-Luc

Bruxelles - Brussel, , Belgium

Ziekenhuis Oost-Limburg

Genk, , Belgium

UZ Gent

Ghent, , Belgium

MC Asklepii OOD

Dupnitsa, , Bulgaria

Spec. Hospital for Active Treatment of Oncological Diseases

Sofia, , Bulgaria

Medical Center Panaceya

Sofia, , Bulgaria

MHAT Niamed

Stara Zagora, , Bulgaria

SHOGAT Prof Dimitar Stamatov

Varna, , Bulgaria

The Ottawa Hospital

Ottawa, Ontario, Canada

The Ottawa Hospital | The Ottawa Hospital Research Institute - Neurology - Ottawa Stroke Program

Ottawa, Ontario, Canada

The Ottawa Hospital

Ottawa, Ontario, Canada

Clinique OVO

Montreal, Quebec, Canada

Alpha Recherche Clinique LB9

Québec, , Canada

First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Guangzhou Women and Children's Medical Center

Guangzhou, Guangdong, China

Wuhan Tongji Reproductive Medicine Hospital

Wuhan, Hubei, China

The Second Affiliated Hospital of Nanjing Medical university

Nanjing, Jiangsu, China

The Second Affiliated Hospital of Nanjing Medical university

Nanjing, Jiangsu, China

Women's Hospital School of Medicine Zhejiang University

Hangzhou, Zhejiang, China

Beijing Obstetrics and Gynecology Hospital,Capital Med.Uni.

Beijing, , China

Peking University First Hospital

Beijing, , China

Fakultni nemocnice Brno

Brno, , Czechia

Gynekologie Meda s.r.o. - Lidicka

Brno střed, , Czechia

GYN-MIKA s.r.o.

České Budějovice, , Czechia

GynCare MUDr. Michael Svec s.r.o.

Pilsen, , Czechia

Centrum gynekologicke rehabilitace

Písek, , Czechia

GYNERA

Prague, , Czechia

Gynekologie Studentsky dum s.r.o.

Prague, , Czechia

Fakultní nemocnice Bulovka

Prague, , Czechia

Dr. Smrhova-Kovacs

Tábor, , Czechia

Parnu Hospital

Pärnu, , Estonia

Clinic Elite

Tartu, , Estonia

HUS / Naistenklinikka

Helsinki, , Finland

Lääkärikeskus Gyneko

Oulu, , Finland

Universitätsklinikum Heidelberg

Heidelberg, Baden-Wurttemberg, Germany

Praxisklinik am Rosengarten

Mannheim, Baden-Wurttemberg, Germany

Praxis f. Gynäkologie und Geburtshilfe

Bernburg, Saxony-Anhalt, Germany

emovis GmbH

Berlin, , Germany

Charité - Campus Virchow-Klinikum (CVK)

Berlin, , Germany

ARETAIEION University Hospital

Athens, , Greece

University General Hospital of Patras | Univ Obs & Gynae Cli

Pátrai, , Greece

Cortex Study Center

Budapest, , Hungary

SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont

Szeged, , Hungary

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, Lazio, Italy

IRCCS Ospedale Policlinico San Martino

Genoa, Liguria, Italy

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Lombardy, Italy

ASST Sette Laghi

Varese, Lombardy, Italy

A.O.U. Careggi

Florence, Tuscany, Italy

A.O.U.I. Verona

Verona, Veneto, Italy

Aiiku Ladies Clinic

Funabashi, Chiba, Japan

Tokyo Bay Urayasu Ichikawa Medical Center

Urayasu, Chiba, Japan

Sou Clinic

Yotsukaidō, Chiba, Japan

Teine Keijinkai Hospital

Sapporo, Hokkaido, Japan

Social Medical Corporation Tokeidai Memorial Hospital

Sapporo, Hokkaido, Japan

Nishikawa Women's Health Clinic

Sapporo, Hokkaido, Japan

Hitachi General Hospital

Hitachi, Ibaraki, Japan

Ibaraki Prefectural Central Hospital

Kasama, Ibaraki, Japan

Fujisawa City Hospital

Fujisawa, Kanagawa, Japan

Yokosuka Kyosai Hospital

Yokosuka, Kanagawa, Japan

Kurashiki Medical Clinic

Kurashiki, Okayama-ken, Japan

Suita Tokushukai Hospital

Suita, Osaka, Japan

Omi Medical Center

Kusatsu, Shiga, Japan

Kashiwazaki ladies clinic

Saitama, Tokyo, Japan

NTT Medical Center Tokyo

Shinagawa-ku, Tokyo, Japan

Toyama Rosai Hospital

Uozu, Toyama, Japan

JCHO Tokuyama Central Hospital

Shūnan, Yamaguchi, Japan

Japanese Red Cross Kumamoto Hospital

Kumamoto, , Japan

Saiseikai Nagasaki Hospital

Nagasaki, , Japan

Nagasaki University Hospital

Nagasaki, , Japan

Latvian Maritime Medicine Center

Riga, , Latvia

Vitols and Vitols Ltd

Riga, , Latvia

I.Vasaraudzes Private Practice

Riga, , Latvia

I.Dinsbergas Physician Practice

Riga, , Latvia

JSC Seimos gydytojas family medical center

Vilnius, , Lithuania

V. Jonaitienes private gynecology clinic

Vilnius, , Lithuania

JSC Gyvenk Silciau Medical Center Maxmeda

Vilnius, , Lithuania

Kirkeparken Spesialistpraksis

Fredrikstad, , Norway

Oslo Universitetssykehus HF, Ullevål

Oslo, , Norway

Sykehuset i Vestfold HF, Tønsberg

Tønsberg, , Norway

Gabinet Ginekologiczny Janusz Tomaszewski

Bialystok, , Poland

MICS Centrum Medyczne Torun

Bydgoszcz, , Poland

CLINICAL MEDICAL RESEARCH Sp. z o. o.

Katowice, , Poland

NZOZ MEDEM Wilk Sp. j.

Katowice, , Poland

Vita Longa Sp. z o.o.

Katowice, , Poland

Prywatny Gabinet Lekarski Ginekologia, Poloznictwo i Ultr.

Lodz, , Poland

Specjalistyczny Gabinet Ginekologiczno-Polozniczy

Lublin, , Poland

NZOZ NOVITA, Specjalistyczne Gabinety Lekarskie S.C

Lublin, , Poland

VitroLive Sp. z o.o.

Szczecin, , Poland

MTZ Clinical Research Sp z o.o.

Warsaw, , Poland

Medical Concierge Centrum Medyczne

Warsaw, , Poland

ULMUS, s r.o.

Hlohovec, , Slovakia

GA Lucenec s.r.o

Lučenec, , Slovakia

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

Veľký Krtíš, , Slovakia

Hospital de Basurto

Bilbao, Vizcaya, Spain

Hospital de la Santa Creu i de Sant Pau | Ginecologia

Barcelona, , Spain

Hospital Universitario 12 de Octubre

Madrid, , Spain

Hospital General Universitario de Valencia

Valencia, , Spain

Countries

United States; Austria; Belgium; Bulgaria; Canada; China; Czechia; Estonia; Finland; Germany; Greece; Hungary; Italy; Japan; Latvia; Lithuania; Norway; Poland; Slovakia; Spain

References

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.

Reference Type: DERIVED

PMID: 38890641 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34978027 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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Other Identifiers

2020-003131-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

20584

Identifier Type: -

Identifier Source: org_study_id