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
- Registration Number
- NCT04614246
- Lead Sponsor
- Bayer
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 215
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Participant must be ≥ 18 years of age at the time of signing the informed consent
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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).
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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.
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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
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Ability to swallow the study intervention, i.e., the different kinds of tablets, as complete units
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Good general health (except for findings related to endometriosis) as proven by medical history, physical and gynecological examinations and laboratory test results
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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.
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Current pregnancy or less than 3 months since delivery, abortion or stop of lactation before Visit 1a
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Hypersensitivity to any ingredient of the study intervention and/or the standardized rescue medications
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Known osteoporosis
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History of a low trauma fracture
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Contraindications for elagolix or the standardized rescue medications
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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
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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)
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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)
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Any disease or condition that may worsen during the study period according to the assessment and opinion of the investigator
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Abnormal uterine bleeding in terms of regularity or heaviness (with the exception of heavy menstrual bleeding that does not require treatment)
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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)
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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
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Major surgery scheduled during the study period
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Non-responsiveness of EAPP to earlier treatment with GnRH-agonists or GnRH-antagonists, based on the judgement of the investigator
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SARS-CoV-2- positive virus RNA test within 4 weeks prior to Visit 1a reported by participant, regardless of whether the participant had symptoms
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History of COVID-19 infection with persistent/ongoing symptoms
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Contact with SARS-CoV-2- positive or COVID-19 patient within the last 4 weeks prior to Visit 1a
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Intake of medication prohibited due to potential drug-drug interaction
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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
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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
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Previous assignment to study intervention (randomization) in this study (allowing previously randomized participants to be re-included into the study may lead to bias)
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Laboratory values outside the inclusion range (specified in the laboratory manual) and considered clinically relevant
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BAY1817080 75 mg BAY1817080 Participants will receive 75 mg of BAY1817080 twice daily over a 12-week intervention period Placebo Placebo Participants will receive placebo matching BAY1817080 twice daily over a 12-week intervention period Elagolix Elagolix Participants will receive 150 mg of Elagolix once daily over a 12-week intervention period BAY1817080 150 mg BAY1817080 Participants will receive 150 mg of BAY1817080 twice daily over a 12-week intervention period BAY1817080 25 mg BAY1817080 Participants will receive 25 mg of BAY1817080 twice daily over a 12-week intervention period
- Primary Outcome Measures
Name Time Method Absolute Change in Mean Worst Endometriosis Associated Pelvic Pain (EAPP), Primary Per Protocol Set (pPPS) change from baseline to week 12 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.
- Secondary Outcome Measures
Name Time Method Number of Participants With Treatment-emergent Adverse Events (TEAE) up to 14 days after the last study medication intake 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.
Least Squares Mean (SE) Changes in Worst EAPP From Baseline to Week 12, Per Protocol Set change from baseline to week 12 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.
Trial Locations
- Locations (144)
Physician Care Clinical Research
🇺🇸Sarasota, Florida, United States
Medisense, Inc.
🇺🇸Atlanta, Georgia, United States
HWC Women's Research Center
🇺🇸Englewood, Ohio, United States
Chattanooga Medical Research, LLC
🇺🇸Chattanooga, Tennessee, United States
UT Health Women's Research Center at Memorial City
🇺🇸Houston, Texas, United States
Centex Studies, Inc.
🇺🇸Houston, Texas, United States
Seattle Clinical Research Center
🇺🇸Seattle, Washington, United States
ClinSearch, LLC
🇺🇸Chattanooga, Tennessee, United States
Biopharma Informatic, Inc.
🇺🇸Houston, Texas, United States
Gynekologie Meda s.r.o. - Lidicka
🇨🇿Brno - stred, Czechia
GYN-MIKA s.r.o.
🇨🇿Ceske Budejovice, Czechia
A.O.U.I. Verona
🇮🇹Verona, Veneto, Italy
Tokyo Bay Urayasu Ichikawa Medical Center
🇯🇵Urayasu, Chiba, Japan
Hitachi General Hospital
🇯🇵Hitachi, Ibaraki, Japan
Lääkärikeskus Gyneko
🇫🇮Oulu, Finland
Wayne State University Physicians Group
🇺🇸Detroit, Michigan, United States
Precision Trials, AZ, LLC
🇺🇸Phoenix, Arizona, United States
Essential Women's Health Associates
🇺🇸Las Vegas, Nevada, United States
Carolina Women's Research & Wellness Center
🇺🇸Durham, North Carolina, United States
Eastern Virginia Medical School
🇺🇸Norfolk, Virginia, United States
Medizinische Universität Graz
🇦🇹Graz, Steiermark, Austria
Clinique OVO
🇨🇦Montreal, Quebec, Canada
ARETAIEION University Hospital
🇬🇷Athens, Greece
Gabinet Ginekologiczny Janusz Tomaszewski
🇵🇱Bialystok, Poland
IRCCS Ospedale Policlinico San Martino
🇮🇹Genova, Liguria, Italy
Alliance for Multispecialty Research, LLC - Fort Meyers
🇺🇸Fort Myers, Florida, United States
A Premier Medical Research of Florida, LLC
🇺🇸Orange City, Florida, United States
Helix Biomedics, LLC
🇺🇸Boynton Beach, Florida, United States
International Clinical Research-Tennessee LLC.
🇺🇸Murfreesboro, Tennessee, United States
Suncoast Clinical Research Center, Inc.
🇺🇸New Port Richey, Florida, United States
Office of Dr. James A. Simon, MD
🇺🇸Washington, District of Columbia, United States
Palmetto Clinical Research
🇺🇸Summerville, South Carolina, United States
Spec. Hospital for Active Treatment of Oncological Diseases
🇧🇬Sofia, Bulgaria
University General Hospital of Patras | Univ Obs & Gynae Cli
🇬🇷Patra, Greece
ULMUS, s r.o.
🇸🇰Hlohovec, Slovakia
Medical Research Center of Memphis, LLC
🇺🇸Memphis, Tennessee, United States
MHAT Niamed
🇧🇬Stara Zagora, Bulgaria
Alpha Recherche Clinique LB9
🇨🇦Quebec, Canada
Vitols and Vitols Ltd
🇱🇻Riga, Latvia
Universitätsklinikum AKH Wien
🇦🇹Wien, Austria
Ziekenhuis Oost-Limburg
🇧🇪Genk, Belgium
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
🇮🇹Roma, Lazio, Italy
A.O.U. Careggi
🇮🇹Firenze, Toscana, Italy
NZOZ NOVITA, Specjalistyczne Gabinety Lekarskie S.C
🇵🇱Lublin, Poland
Universitätsklinikum Heidelberg
🇩🇪Heidelberg, Baden-Württemberg, Germany
AZ Jan Palfijn Gent
🇧🇪Gent, Oost-Vlaanderen, Belgium
Praxis f. Gynäkologie und Geburtshilfe
🇩🇪Bernburg, Sachsen-Anhalt, Germany
Charité - Campus Virchow-Klinikum (CVK)
🇩🇪Berlin, Germany
I.Vasaraudzes Private Practice
🇱🇻Riga, Latvia
I.Dinsbergas Physician Practice
🇱🇻Riga, Latvia
GA Lucenec s.r.o
🇸🇰Lucenec, Slovakia
Yokosuka Kyosai Hospital
🇯🇵Yokosuka, Kanagawa, Japan
Kashiwazaki ladies clinic
🇯🇵Saitama, Tokyo, Japan
Ibaraki Prefectural Central Hospital
🇯🇵Kasama, Ibaraki, Japan
Kurashiki Medical Clinic
🇯🇵Kurashiki, Okayama, Japan
Fujisawa City Hospital
🇯🇵Fujisawa, Kanagawa, Japan
Suita Tokushukai Hospital
🇯🇵Suita, Osaka, Japan
Omi Medical Center
🇯🇵Kusatsu, Shiga, Japan
Toyama Rosai Hospital
🇯🇵Uozu, Toyama, Japan
JCHO Tokuyama Central Hospital
🇯🇵Shunan, 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
JSC Seimos gydytojas family medical center
🇱🇹Vilnius, Lithuania
V. Jonaitienes private gynecology clinic
🇱🇹Vilnius, Lithuania
JSC Gyvenk Silciau Medical Center Maxmeda
🇱🇹Vilnius, Lithuania
MICS Centrum Medyczne Torun
🇵🇱Bydgoszcz, Poland
Kirkeparken Spesialistpraksis
🇳🇴Fredrikstad, Norway
NZOZ MEDEM Wilk Sp. j.
🇵🇱Katowice, Poland
Hospital General Universitario de Valencia
🇪🇸Valencia, Spain
Sykehuset i Vestfold HF, Tønsberg
🇳🇴Tønsberg, Norway
CLINICAL MEDICAL RESEARCH Sp. z o. o.
🇵🇱Katowice, Poland
Vita Longa Sp. z o.o.
🇵🇱Katowice, Poland
Prywatny Gabinet Lekarski Ginekologia, Poloznictwo i Ultr.
🇵🇱Lodz, Poland
MTZ Clinical Research Sp z o.o.
🇵🇱Warszawa, Poland
Medical Concierge Centrum Medyczne
🇵🇱Warszawa, Poland
Hospital de Basurto
🇪🇸Bilbao, Vizcaya, Spain
Specjalistyczny Gabinet Ginekologiczno-Polozniczy
🇵🇱Lublin, Poland
VitroLive Sp. z o.o.
🇵🇱Szczecin, Poland
Virina sano, s.r.o. Gynekologicko porodnicka ambulancia
🇸🇰Velky Krtis, Slovakia
Accel Research Sites - Cahaba Medical Care
🇺🇸Birmingham, Alabama, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Hospital de la Santa Creu i de Sant Pau | Ginecologia
🇪🇸Barcelona, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Diagnamics, Inc.
🇺🇸Encinitas, California, United States
Mobile Ob-Gyn, PC
🇺🇸Mobile, Alabama, United States
West Coast OB/GYN Associates
🇺🇸San Diego, California, United States
Advanced Women's Health Institute
🇺🇸Greenwood Village, Colorado, United States
Paramount Research Solutions-College Park
🇺🇸College Park, Georgia, United States
Augusta University Medical Center
🇺🇸Augusta, Georgia, United States
Journey Medical Research
🇺🇸Snellville, Georgia, United States
Clinical Research Prime
🇺🇸Idaho Falls, Idaho, United States
Continental Clinical Solutions, LLC
🇺🇸Towson, Maryland, United States
Bosque Womens Care
🇺🇸Albuquerque, New Mexico, United States
Clinical Inquest Center, Ltd.
🇺🇸Beavercreek, Ohio, United States
Lyndhurst Clinical Research
🇺🇸Winston-Salem, North Carolina, United States
Aventiv Research - Dublin
🇺🇸Dublin, Ohio, United States
Centricity Research formerly Aventiv - Dublin
🇺🇸Dublin, Ohio, United States
University Hospitals Landerbrook Health Center
🇺🇸Mayfield Heights, Ohio, United States
Discovery Clinical Trials - Dallas
🇺🇸Dallas, Texas, United States
Advances in Health
🇺🇸Pearland, Texas, United States
Eastern Virginia Medical School | OB/GYN Clinical Research Center
🇺🇸Norfolk, Virginia, United States
Tidewater Clinical Research, Inc.
🇺🇸Norfolk, Virginia, United States
Virginia Physicians For Women
🇺🇸North Chesterfield, Virginia, United States
CU Saint-Luc/UZ St-Luc
🇧🇪Bruxelles - Brussel, Belgium
UZ Gent
🇧🇪Gent, Belgium
MC Asklepii OOD
🇧🇬Dupnitza, Bulgaria
Medical Center Panaceya
🇧🇬Sofia, Bulgaria
The Ottawa Hospital
🇨🇦Ottawa, Ontario, Canada
SHOGAT Prof Dimitar Stamatov
🇧🇬Varna, Bulgaria
First Affiliated Hospital of Guangzhou Medical University
🇨🇳Guangzhou, Guangdong, China
Beijing Obstetrics and Gynecology Hospital,Capital Med.Uni.
🇨🇳Beijing, China
Guangzhou Women and Children's Medical Center
🇨🇳Guangzhou, Guangdong, China
Wuhan Tongji Reproductive Medicine Hospital
🇨🇳Wuhan, Hubei, China
Women's Hospital School of Medicine Zhejiang University
🇨🇳Hangzhou, Zhejiang, China
The Second Affiliated Hospital of Nanjing Medical university
🇨🇳Nanjing, Jiangsu, China
Peking University First Hospital
🇨🇳Beijing, China
Fakultni nemocnice Brno
🇨🇿Brno, Czechia
GYNERA
🇨🇿Praha 5, Czechia
Centrum gynekologicke rehabilitace
🇨🇿Pisek, Czechia
GynCare MUDr. Michael Svec s.r.o.
🇨🇿Plzen, Czechia
Gynekologie Studentsky dum s.r.o.
🇨🇿Praha 6, Czechia
Fakultní nemocnice Bulovka
🇨🇿Praha 8, Czechia
Dr. Smrhova-Kovacs
🇨🇿Tabor, Czechia
HUS / Naistenklinikka
🇫🇮Helsinki, Finland
Parnu Hospital
🇪🇪Parnu, Estonia
Clinic Elite
🇪🇪Tartu, Estonia
emovis GmbH
🇩🇪Berlin, Germany
SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont
🇭🇺Szeged, Hungary
Cortex Study Center
🇭🇺Budapest, Hungary
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
🇮🇹Milano, Lombardia, Italy
ASST Sette Laghi
🇮🇹Varese, Lombardia, Italy
Aiiku Ladies Clinic
🇯🇵Funabashi, Chiba, Japan
Sou Clinic
🇯🇵Yotsukaido, 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
Oslo Universitetssykehus HF, Ullevål
🇳🇴Oslo, Norway
SUNY Downstate Medical Center
🇺🇸Brooklyn, New York, United States
The Ottawa Hospital | The Ottawa Hospital Research Institute - Neurology - Ottawa Stroke Program
🇨🇦Ottawa, Ontario, Canada
Southern Clinical Research Associates LLC
🇺🇸Metairie, Louisiana, United States
Praxisklinik am Rosengarten
🇩🇪Mannheim, Baden-Württemberg, Germany
NTT Medical Center Tokyo
🇯🇵Shinagawa-ku, Tokyo, Japan