AzTrials
AzTrials

EndometriosisPhase 2SCHUMANNNCT04614246

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

A Phase 2 study testing BAY1817080 and Elagolix in people with Endometriosis, run by Bayer at 147 sites in 20 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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 Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Endometriosis
What is being tested?
BAY1817080 and Elagolix
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
215 participants
Where
147 sitesin 20 countries
Study dates
29 Jan 2021to 3 May 2022
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 12Show fewer
  • 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.

Who cannot join

  • 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
Show all 28Show fewer
  • 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 locations and contacts

147 sites in 20 countries.

147 sites in 20 countries

United States47 sites

  • Bosque Womens Care

    Albuquerque, New Mexico, 87109

  • Medisense, Inc.

    Atlanta, Georgia, 30363

  • Augusta University Medical Center

    Augusta, Georgia, 30912

  • Clinical Inquest Center, Ltd.

    Beavercreek, Ohio, 45432

  • Accel Research Sites - Cahaba Medical Care

    Birmingham, Alabama, 35218

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294-0026

  • Helix Biomedics, LLC

    Boynton Beach, Florida, 33435

  • SUNY Downstate Medical Center

    Brooklyn, New York, 11203

  • Chattanooga Medical Research, LLC

    Chattanooga, Tennessee, 37404

  • ClinSearch, LLC

    Chattanooga, Tennessee, 37421

  • Paramount Research Solutions-College Park

    College Park, Georgia, 30349

  • Discovery Clinical Trials - Dallas

    Dallas, Texas, 75230

  • Wayne State University Physicians Group

    Detroit, Michigan, 48201

  • Aventiv Research - Dublin

    Dublin, Ohio, 43016

  • Centricity Research formerly Aventiv - Dublin

    Dublin, Ohio, 43016

  • Carolina Women's Research & Wellness Center

    Durham, North Carolina, 27713

  • Diagnamics, Inc.

    Encinitas, California, 92024

  • HWC Women's Research Center

    Englewood, Ohio, 45322

  • Alliance for Multispecialty Research, LLC - Fort Meyers

    Fort Myers, Florida, 33912

  • Advanced Women's Health Institute

    Greenwood Village, Colorado, 80111

  • UT Health Women's Research Center at Memorial City

    Houston, Texas, 77024

  • Biopharma Informatic, Inc.

    Houston, Texas, 77043

  • Centex Studies, Inc.

    Houston, Texas, 77058

  • Centex Studies, Inc.

    Houston, Texas, 77090

  • Clinical Research Prime

    Idaho Falls, Idaho, 83404

  • Essential Women's Health Associates

    Las Vegas, Nevada, 89113

  • University Hospitals Landerbrook Health Center

    Mayfield Heights, Ohio, 44124

  • Medical Research Center of Memphis, LLC

    Memphis, Tennessee, 38120

  • Southern Clinical Research Associates LLC

    Metairie, Louisiana, 70001

  • Mobile Ob-Gyn, PC

    Mobile, Alabama, 36608-6703

  • International Clinical Research-Tennessee LLC.

    Murfreesboro, Tennessee, 37130

  • Suncoast Clinical Research Center, Inc.

    New Port Richey, Florida, 34652

  • Tidewater Clinical Research, Inc.

    Norfolk, Virginia, 23456

  • Eastern Virginia Medical School | OB/GYN Clinical Research Center

    Norfolk, Virginia, 23507

  • Eastern Virginia Medical School

    Norfolk, Virginia, 23507

  • Virginia Physicians For Women

    North Chesterfield, Virginia, 23235

  • A Premier Medical Research of Florida, LLC

    Orange City, Florida, 32763

  • Advances in Health

    Pearland, Texas, 77584

  • Precision Trials, AZ, LLC

    Phoenix, Arizona, 85032

  • West Coast OB/GYN Associates

    San Diego, California, 92123

  • Physician Care Clinical Research

    Sarasota, Florida, 34239

  • Seattle Clinical Research Center

    Seattle, Washington, 98105

  • Journey Medical Research

    Snellville, Georgia, 30078

  • Palmetto Clinical Research

    Summerville, South Carolina, 29485

  • Continental Clinical Solutions, LLC

    Towson, Maryland, 21204

  • Office of Dr. James A. Simon, MD

    Washington D.C., District of Columbia, 20036

  • Lyndhurst Clinical Research

    Winston-Salem, North Carolina, 27103

Other trials in United States

Japan20 sites

  • Fujisawa City Hospital

    Fujisawa, Kanagawa, 251-8550

  • Aiiku Ladies Clinic

    Funabashi, Chiba, 274-0071

  • Hitachi General Hospital

    Hitachi, Ibaraki, 317-0077

  • Ibaraki Prefectural Central Hospital

    Kasama, Ibaraki, 309-1793

  • Japanese Red Cross Kumamoto Hospital

    Kumamoto, 861-8520

  • Kurashiki Medical Clinic

    Kurashiki, Okayama-ken, 710-0824

  • Omi Medical Center

    Kusatsu, Shiga, 525-8585

  • Saiseikai Nagasaki Hospital

    Nagasaki, 850-0003

  • Nagasaki University Hospital

    Nagasaki, 852-8501

  • Kashiwazaki ladies clinic

    Saitama, Tokyo, 330-0855

  • Teine Keijinkai Hospital

    Sapporo, Hokkaido, 006-8555

  • Social Medical Corporation Tokeidai Memorial Hospital

    Sapporo, Hokkaido, 060-0031

  • Nishikawa Women's Health Clinic

    Sapporo, Hokkaido, 060-0061

  • NTT Medical Center Tokyo

    Shinagawa-ku, Tokyo, 141-8625

  • JCHO Tokuyama Central Hospital

    Shūnan, Yamaguchi, 745-8522

  • Suita Tokushukai Hospital

    Suita, Osaka, 565-0814

  • Toyama Rosai Hospital

    Uozu, Toyama, 937-0042

  • Tokyo Bay Urayasu Ichikawa Medical Center

    Urayasu, Chiba, 279-0001

  • Yokosuka Kyosai Hospital

    Yokosuka, Kanagawa, 238-8558

  • Sou Clinic

    Yotsukaidō, Chiba, 284-0001

Other trials in Japan

Poland11 sites

  • Gabinet Ginekologiczny Janusz Tomaszewski

    Bialystok, 15-244

  • MICS Centrum Medyczne Torun

    Bydgoszcz, 85-065

  • CLINICAL MEDICAL RESEARCH Sp. z o. o.

    Katowice, 40-156

  • NZOZ MEDEM Wilk Sp. j.

    Katowice, 40-301

  • Vita Longa Sp. z o.o.

    Katowice, 40-748

  • Prywatny Gabinet Lekarski Ginekologia, Poloznictwo i Ultr.

    Lodz, 90-602

  • Specjalistyczny Gabinet Ginekologiczno-Polozniczy

    Lublin, 20-400

  • NZOZ NOVITA, Specjalistyczne Gabinety Lekarskie S.C

    Lublin, 20-632

  • VitroLive Sp. z o.o.

    Szczecin, 70-483

  • MTZ Clinical Research Sp z o.o.

    Warsaw, 02-106

  • Medical Concierge Centrum Medyczne

    Warsaw, 02-798

Other trials in Poland

Czechia9 sites

  • Fakultni nemocnice Brno

    Brno, 625 00

  • Gynekologie Meda s.r.o. - Lidicka

    Brno-střed, 60200

  • GYN-MIKA s.r.o.

    České Budějovice, 370 01

  • GynCare MUDr. Michael Svec s.r.o.

    Pilsen, 326 00

  • Centrum gynekologicke rehabilitace

    Písek, 39701

  • GYNERA

    Prague, 156 00

  • Gynekologie Studentsky dum s.r.o.

    Prague, 160 00

  • Fakultní nemocnice Bulovka

    Prague, 180 81

  • Dr. Smrhova-Kovacs

    Tábor, 39003

Other trials in Czechia

China8 sites

  • Beijing Obstetrics and Gynecology Hospital,Capital Med.Uni.

    Beijing, 100026

  • Peking University First Hospital

    Beijing, 100034

  • First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510120

  • Guangzhou Women and Children's Medical Center

    Guangzhou, Guangdong, 510623

  • Women's Hospital School of Medicine Zhejiang University

    Hangzhou, Zhejiang, 310006

  • The Second Affiliated Hospital of Nanjing Medical university

    Nanjing, Jiangsu, 210000

  • The Second Affiliated Hospital of Nanjing Medical university

    Nanjing, Jiangsu, 210011

  • Wuhan Tongji Reproductive Medicine Hospital

    Wuhan, Hubei, 430013

Other trials in China

Italy6 sites

  • A.O.U. Careggi

    Florence, Tuscany, 50134

  • IRCCS Ospedale Policlinico San Martino

    Genoa, Liguria, 16132

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

    Milan, Lombardy, 20122

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Rome, Lazio, 00168

  • ASST Sette Laghi

    Varese, Lombardy, 21100

  • A.O.U.I. Verona

    Verona, Veneto, 37126

Other trials in Italy

Bulgaria5 sites

  • MC Asklepii OOD

    Dupnitsa, 2600

  • Spec. Hospital for Active Treatment of Oncological Diseases

    Sofia, 1233

  • Medical Center Panaceya

    Sofia, 1606

  • MHAT Niamed

    Stara Zagora, 6000

  • SHOGAT Prof Dimitar Stamatov

    Varna, 9000

Other trials in Bulgaria

Canada5 sites

  • Clinique OVO

    Montreal, Quebec, H4P 2S4

  • The Ottawa Hospital

    Ottawa, Ontario, K1H 7W9

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

    Ottawa, Ontario, K1Y4E9

  • The Ottawa Hospital

    Ottawa, Ontario, K1Y4E9

  • Alpha Recherche Clinique LB9

    Québec, G2J 0C4

Other trials in Canada

Germany5 sites

  • emovis GmbH

    Berlin, 10629

  • Charité - Campus Virchow-Klinikum (CVK)

    Berlin, 13353

  • Praxis f. Gynäkologie und Geburtshilfe

    Bernburg, Saxony-Anhalt, 06406

  • Universitätsklinikum Heidelberg

    Heidelberg, Baden-Wurttemberg, 69120

  • Praxisklinik am Rosengarten

    Mannheim, Baden-Wurttemberg, 68165

Other trials in Germany

Belgium4 sites

  • CU Saint-Luc/UZ St-Luc

    Bruxelles - Brussel, 1200

  • Ziekenhuis Oost-Limburg

    Genk, 3600

  • AZ Jan Palfijn Gent

    Ghent, Oost-Vlaanderen, 9000

  • UZ Gent

    Ghent, 9000

Other trials in Belgium

Latvia4 sites

  • Latvian Maritime Medicine Center

    Riga, LV-1005

  • Vitols and Vitols Ltd

    Riga, LV-1006

  • I.Vasaraudzes Private Practice

    Riga, LV-1011

  • I.Dinsbergas Physician Practice

    Riga, LV-1013

Other trials in Latvia

Spain4 sites

  • Hospital de la Santa Creu i de Sant Pau | Ginecologia

    Barcelona, 08041

  • Hospital de Basurto

    Bilbao, Vizcaya, 48013

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital General Universitario de Valencia

    Valencia, 46014

Other trials in Spain

Lithuania3 sites

  • JSC Seimos gydytojas family medical center

    Vilnius, LT-01118

  • V. Jonaitienes private gynecology clinic

    Vilnius, LT-01123

  • JSC Gyvenk Silciau Medical Center Maxmeda

    Vilnius, LT-03225

Other trials in Lithuania

Norway3 sites

  • Kirkeparken Spesialistpraksis

    Fredrikstad, 1605

  • Oslo Universitetssykehus HF, Ullevål

    Oslo, 0450

  • Sykehuset i Vestfold HF, Tønsberg

    Tønsberg, 3116

Other trials in Norway

Slovakia3 sites

  • ULMUS, s r.o.

    Hlohovec, 920 01

  • GA Lucenec s.r.o

    Lučenec, 984 01

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

    Veľký Krtíš, 990 01

Other trials in Slovakia

Austria2 sites

  • Medizinische Universität Graz

    Graz, Styria, 8036

  • Universitätsklinikum AKH Wien

    Vienna, 1090

Other trials in Austria

Estonia2 sites

  • Parnu Hospital

    Pärnu, 80010

  • Clinic Elite

    Tartu, 50407

Other trials in Estonia

Finland2 sites

  • HUS / Naistenklinikka

    Helsinki, 00029

  • Lääkärikeskus Gyneko

    Oulu, 90100

Other trials in Finland

Greece2 sites

  • ARETAIEION University Hospital

    Athens, 11528

  • University General Hospital of Patras | Univ Obs & Gynae Cli

    Pátrai, 26504

Other trials in Greece

Hungary2 sites

  • Cortex Study Center

    Budapest, 1026

  • SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont

    Szeged, 6725

Other trials in Hungary

About this study

Official title: 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
Conditions
Endometriosis
Being tested
BAY1817080, Elagolix, Placebo
Medical subject headings
Endometriosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BAY1817080Drug

    Tablet, oral administration

  • ElagolixDrug

    Tablet, oral administration

  • PlaceboDrug

    Tablet, oral administration

Study groups in NCT04614246
Study groupRoleWhat they receive
BAY1817080 150 mgExperimentalParticipants will receive 150 mg of BAY1817080 twice daily over a 12-week intervention period
Receives: Drug: BAY1817080
BAY1817080 75 mgExperimentalParticipants will receive 75 mg of BAY1817080 twice daily over a 12-week intervention period
Receives: Drug: BAY1817080
BAY1817080 25 mgExperimentalParticipants will receive 25 mg of BAY1817080 twice daily over a 12-week intervention period
Receives: Drug: BAY1817080
ElagolixActive comparatorParticipants will receive 150 mg of Elagolix once daily over a 12-week intervention period
Receives: Drug: Elagolix
PlaceboPlacebo comparatorParticipants will receive placebo matching BAY1817080 twice daily over a 12-week intervention period
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: change from baseline to week 12

Secondary outcomes (2)

  1. 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.

    Measured: change from baseline to week 12

  2. 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.

    Measured: up to 14 days after the last study medication intake

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Nov 2020
  2. Study start29 Jan 2021
  3. Primary completion17 Jan 2022
  4. Study completion3 May 2022

Why it stopped: Study terminated by Sponsor

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
215 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04614246
Sponsor's protocol ID
20584
Other IDs
2020-003131-16
Acronym
SCHUMANN
Status last verified
Jul 2023
First submitted
2 Nov 2020
Last updated
1 Aug 2023
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • 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.

    PubMed 38890641

  • 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.

    PubMed 34978027

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BAY1817080 and Elagolix in people with Endometriosis, run by Bayer at 147 sites in 20 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 147 sites in United States, Japan, Poland, Czechia, China and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Absolute Change in Mean Worst Endometriosis Associated Pelvic Pain (EAPP), Primary Per Protocol Set (pPPS) (time frame: change from baseline to week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04614246, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023.

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