SCHUMANN: 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

Sponsor

Bayer (Industry)

Overall Status

Completed

CT.gov ID

NCT04614246

Collaborator

(none)

194

Enrollment

142

Locations

Arms

15.1

Actual Duration (Months)

1.4

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Endometriosis	Drug: BAY1817080 Drug: Elagolix Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

194 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Double blind to placebo and open-label for active comparator

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jan 29, 2021

Actual Primary Completion Date :

Jan 27, 2022

Actual Study Completion Date :

May 3, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Absolute change in mean worst EAPP from baseline to end of intervention [At baseline (last 28 days before start of study drug) and at day 57-84 (+3)]
Endometriosis associated pelvic pain (EAPP) will be measured daily on the numerical rating scale (NRS) ranging from 0 to 10 by item 1 of the Endometriosis Symptom Diary (ESD). The higher number indicates a higher level of pain experience

Secondary Outcome Measures

Number of participants with treatment-emergent adverse events [From start of study drug administration until 14 days after the last study medication intake]
Any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Accel Research Sites - Cahaba Medical Care	Birmingham	Alabama	United States	35218
2	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294-0026
3	Mobile Ob-Gyn, PC	Mobile	Alabama	United States	36608-6703
4	Precision Trials, AZ, LLC	Phoenix	Arizona	United States	85032
5	Diagnamics, Inc.	Encinitas	California	United States	92024
6	West Coast OB/GYN Associates	San Diego	California	United States	92123
7	Advanced Women's Health Institute	Greenwood Village	Colorado	United States	80111
8	Office of Dr. James A. Simon, MD	Washington	District of Columbia	United States	20036
9	Helix Biomedics, LLC	Boynton Beach	Florida	United States	33435
10	Alliance for Multispecialty Research, LLC	Fort Myers	Florida	United States	33912
11	Suncoast Clinical Research Center, Inc.	New Port Richey	Florida	United States	34652
12	A Premier Medical Research of Florida, LLC	Orange City	Florida	United States	32763
13	Physician Care Clinical Research	Sarasota	Florida	United States	34239
14	Medisense, Inc.	Atlanta	Georgia	United States	30363
15	Augusta University Medical Center	Augusta	Georgia	United States	30912
16	Paramount Research Solutions-College Park	College Park	Georgia	United States	30349
17	Journey Medical Research	Snellville	Georgia	United States	30078
18	Clinical Research Prime	Idaho Falls	Idaho	United States	83404
19	Southern Clinical Research Associates LLC	Metairie	Louisiana	United States	70001
20	Continental Clinical Solutions, LLC	Towson	Maryland	United States	21204
21	Wayne State University Physicians Group	Detroit	Michigan	United States	48201
22	Essential Women's Health Associates	Las Vegas	Nevada	United States	89113
23	Bosque Womens Care	Albuquerque	New Mexico	United States	87109
24	SUNY Downstate Medical Center	Brooklyn	New York	United States	11203
25	Carolina Women's Research & Wellness Center	Durham	North Carolina	United States	27713
26	Lyndhurst Clinical Research	Winston-Salem	North Carolina	United States	27103
27	Clinical Inquest Center, Ltd.	Beavercreek	Ohio	United States	45432
28	Aventiv Research - Dublin	Dublin	Ohio	United States	43016
29	HWC Women's Research Center	Englewood	Ohio	United States	45322
30	University Hospitals Landerbrook Health Center	Mayfield Heights	Ohio	United States	44124
31	Palmetto Clinical Research	Summerville	South Carolina	United States	29485
32	Chattanooga Medical Research, LLC	Chattanooga	Tennessee	United States	37404
33	ClinSearch, LLC	Chattanooga	Tennessee	United States	37421
34	Medical Research Center of Memphis, LLC	Memphis	Tennessee	United States	38120
35	International Clinical Research-Tennessee LLC.	Murfreesboro	Tennessee	United States	37130
36	Discovery Clinical Trials	Dallas	Texas	United States	75230
37	UT Health Women's Research Center at Memorial City	Houston	Texas	United States	77024
38	Biopharma Informatic, Inc.	Houston	Texas	United States	77043
39	Centex Studies, Inc.	Houston	Texas	United States	77058
40	Centex Studies, Inc.	Houston	Texas	United States	77090
41	Advances in Health	Pearland	Texas	United States	77584
42	Tidewater Clinical Research, Inc.	Norfolk	Virginia	United States	23456
43	Eastern Virginia Medical School	Norfolk	Virginia	United States	23507
44	Virginia Physicians For Women	North Chesterfield	Virginia	United States	23235
45	Seattle Clinical Research Center	Seattle	Washington	United States	98105
46	Medizinische Universität Graz	Graz	Steiermark	Austria	8036
47	Universitätsklinikum AKH Wien	Wien		Austria	1090
48	AZ Jan Palfijn Gent	Gent	Oost-Vlaanderen	Belgium	9000
49	CU Saint-Luc/UZ St-Luc	Bruxelles - Brussel		Belgium	1200
50	Ziekenhuis Oost-Limburg	Genk		Belgium	3600
51	UZ Gent	Gent		Belgium	9000
52	MC Asklepii OOD	Dupnitza		Bulgaria	2600
53	Spec. Hospital for Active Treatment of Oncological Diseases	Sofia		Bulgaria	1233
54	Medical Center Panaceya	Sofia		Bulgaria	1606
55	MHAT Niamed	Stara Zagora		Bulgaria	6000
56	SHOGAT Prof Dimitar Stamatov	Varna		Bulgaria	9000
57	The Ottawa Hospital	Ottawa	Ontario	Canada	K1H 7W9
58	Clinique OVO	Montreal	Quebec	Canada	H4P 2S4
59	Alpha Recherche Clinique LB9	Quebec		Canada	G2J 0C4
60	First Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong	China	510120
61	Guangzhou Women and Children's Medical Center	Guangzhou	Guangdong	China	510623
62	Wuhan Tongji Reproductive Medicine Hospital	Wuhan	Hubei	China	430013
63	The Second Affiliated Hospital of Nanjing Medical university	Nanjing	Jiangsu	China	210011
64	Women's Hospital School of Medicine Zhejiang University	Hangzhou	Zhejiang	China	310006
65	Beijing Obstetrics and Gynecology Hospital,Capital Med.Uni.	Beijing		China	100026
66	Peking University First Hospital	Beijing		China	100034
67	Gynekologie Meda s.r.o. - Lidicka	Brno - stred		Czechia	60200
68	Fakultni nemocnice Brno	Brno		Czechia	625 00
69	GYN-MIKA s.r.o.	Ceske Budejovice		Czechia	370 01
70	Centrum gynekologicke rehabilitace	Pisek		Czechia	39701
71	GynCare MUDr. Michael Svec s.r.o.	Plzen		Czechia	326 00
72	GYNERA	Praha 5		Czechia	156 00
73	Gynekologie Studentsky dum s.r.o.	Praha 6		Czechia	160 00
74	Fakultní nemocnice Bulovka	Praha 8		Czechia	180 81
75	Dr. Smrhova-Kovacs	Tabor		Czechia	39003
76	Parnu Hospital	Parnu		Estonia	80010
77	Clinic Elite	Tartu		Estonia	50407
78	HUS / Naistenklinikka	Helsinki		Finland	00029
79	Lääkärikeskus Gyneko	Oulu		Finland	90100
80	Universitätsklinikum Heidelberg	Heidelberg	Baden-Württemberg	Germany	69120
81	Praxisklinik am Rosengarten	Mannheim	Baden-Württemberg	Germany	68165
82	Praxis f. Gynäkologie und Geburtshilfe	Bernburg	Sachsen-Anhalt	Germany	06406
83	emovis GmbH	Berlin		Germany	10629
84	Charité - Campus Virchow-Klinikum (CVK)	Berlin		Germany	13353
85	ARETAIEION University Hospital	Athens		Greece	11528
86	University General Hospital of Patras \| Univ Obs & Gynae Cli	Patra		Greece	26504
87	Cortex Study Center	Budapest		Hungary	1026
88	SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont	Szeged		Hungary	6725
89	Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Roma	Lazio	Italy	00168
90	IRCCS Ospedale Policlinico San Martino	Genova	Liguria	Italy	16132
91	Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico	Milano	Lombardia	Italy	20122
92	ASST Sette Laghi	Varese	Lombardia	Italy	21100
93	A.O.U. Careggi	Firenze	Toscana	Italy	50134
94	A.O.U.I. Verona	Verona	Veneto	Italy	37126
95	Aiiku Ladies Clinic	Funabashi	Chiba	Japan	274-0071
96	Tokyo Bay Urayasu Ichikawa Medical Center	Urayasu	Chiba	Japan	279-0001
97	Sou Clinic	Yotsukaido	Chiba	Japan	284-0001
98	Teine Keijinkai Hospital	Sapporo	Hokkaido	Japan	006-8555
99	Social Medical Corporation Tokeidai Memorial Hospital	Sapporo	Hokkaido	Japan	060-0031
100	Nishikawa Women's Health Clinic	Sapporo	Hokkaido	Japan	060-0061
101	Hitachi General Hospital	Hitachi	Ibaraki	Japan	317-0077
102	Ibaraki Prefectural Central Hospital	Kasama	Ibaraki	Japan	309-1793
103	Fujisawa City Hospital	Fujisawa	Kanagawa	Japan	251-8550
104	Yokosuka Kyosai Hospital	Yokosuka	Kanagawa	Japan	238-8558
105	Kurashiki Medical Clinic	Kurashiki	Okayama	Japan	710-0824
106	Suita Tokushukai Hospital	Suita	Osaka	Japan	565-0814
107	Omi Medical Center	Kusatsu	Shiga	Japan	525-8585
108	Kashiwazaki ladies clinic	Saitama	Tokyo	Japan	330-0855
109	NTT Medical Center Tokyo	Shinagawa-ku	Tokyo	Japan	141-8625
110	Toyama Rosai Hospital	Uozu	Toyama	Japan	937-0042
111	JCHO Tokuyama Central Hospital	Shunan	Yamaguchi	Japan	745-8522
112	Japanese Red Cross Kumamoto Hospital	Kumamoto		Japan	861-8520
113	Saiseikai Nagasaki Hospital	Nagasaki		Japan	850-0003
114	Nagasaki University Hospital	Nagasaki		Japan	852-8501
115	Latvian Maritime Medicine Center	Riga		Latvia	LV-1005
116	Vitols and Vitols Ltd	Riga		Latvia	LV-1006
117	I.Vasaraudzes Private Practice	Riga		Latvia	LV-1011
118	I.Dinsbergas Physician Practice	Riga		Latvia	LV-1013
119	JSC Seimos gydytojas family medical center	Vilnius		Lithuania	LT-01118
120	V. Jonaitienes private gynecology clinic	Vilnius		Lithuania	LT-01123
121	JSC Gyvenk Silciau Medical Center Maxmeda	Vilnius		Lithuania	LT-03225
122	Kirkeparken Spesialistpraksis	Fredrikstad		Norway	1605
123	Oslo Universitetssykehus HF, Ullevål	Oslo		Norway	0450
124	Sykehuset i Vestfold HF, Tønsberg	Tønsberg		Norway	3116
125	Gabinet Ginekologiczny Janusz Tomaszewski	Bialystok		Poland	15-244
126	MICS Centrum Medyczne Torun	Bydgoszcz		Poland	85-065
127	CLINICAL MEDICAL RESEARCH Sp. z o. o.	Katowice		Poland	40-156
128	Indywidualna Specjalistyczna Praktyka Lek Krzysztof Wilk	Katowice		Poland	40-301
129	Vita Longa Sp. z o.o.	Katowice		Poland	40-748
130	Prywatny Gabinet Lekarski Ginekologia, Poloznictwo i Ultr.	Lodz		Poland	90-602
131	Specjalistyczny Gabinet Ginekologiczno-Polozniczy	Lublin		Poland	20-400
132	NZOZ NOVITA, Specjalistyczne Gabinety Lekarskie S.C	Lublin		Poland	20-632
133	VitroLive Sp. z o.o.	Szczecin		Poland	70-483
134	MTZ Clinical Research Sp z o.o.	Warszawa		Poland	02-106
135	Medical Concierge Centrum Medyczne	Warszawa		Poland	02-798
136	ULMUS, s r.o.	Hlohovec		Slovakia	920 01
137	GA Lucenec s.r.o	Lucenec		Slovakia	984 01
138	Virina sano, s.r.o. Gynekologicko porodnicka ambulancia	Velky Krtis		Slovakia	990 01
139	Hospital de Basurto	Bilbao	Vizcaya	Spain	48013
140	Hospital de la Santa Creu i de Sant Pau	Barcelona		Spain	08025
141	Hospital Universitario 12 de Octubre	Madrid		Spain	28041
142	Hospital General Universitario de Valencia	Valencia		Spain	46014

Sponsors and Collaborators

Bayer

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Bayer

ClinicalTrials.gov Identifier:

NCT04614246

Other Study ID Numbers:

20584
2020-003131-16

First Posted:

Nov 3, 2020

Last Update Posted:

Jun 21, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Endometriosis

Study Results

No Results Posted as of Jun 21, 2022