A Study to Test Whether Study Drug BAY1128688 Brings Pain Relief to Women With Endometriosis and if so to Get a First Idea Which Dose(s) Work Best

NCT03373422 | Terminated Phase 2

• 2 other identifiers: 174722017-000244-18
• Study Type: interventional
• Target: 121
• Locations: 13 countries
• Sites: 68

Brief Summary

Purpose of the study is to test whether study drug BAY1128688 brings relief for pain to women with endometriosis and if so to get a first impression which dose(s) work best.

Conditions

Endometriosis

Outcome Measures

Primary Outcomes (1)

• Absolute change in mean pain of the 7 days with worst EAPP comparing the 28-day baseline cycle (baseline period of daily pain recordings) to the 28-day end of treatment cycle (daily pain recordings during the last 28 days of the treatment period)

  EAPP: endometriosis-associated pelvic pain, measured on the NRS (Numerical Rating Scale) by item 1 of the ESD (Endometriosis Symptom Diary)

  12 weeks

Secondary Outcomes (1)

• Incidence of treatment-emergent adverse events

  18 weeks

Study Arms (6)

BAY1128688 (dose 1)

EXPERIMENTAL

One BAY1128688 tablet (lowest dose) in the morning, one placebo tablet in the evening

Drug: BAY1128688; Drug: Placebo

BAY1128688 (dose 2)

EXPERIMENTAL

One BAY1128688 tablet (first intermediate dose) in the morning, one placebo tablet in the evening

Drug: BAY1128688; Drug: Placebo

BAY1128688 (dose 3)

EXPERIMENTAL

One BAY1128688 tablet (second intermediate dose) in the morning, one placebo tablet in the evening

Drug: BAY1128688; Drug: Placebo

BAY1128688 (dose 4)

EXPERIMENTAL

One BAY1128688 tablet (second intermediate dose) in the morning and one in the evening

Drug: BAY1128688

BAY1128688 (dose 5)

EXPERIMENTAL

One BAY1128688 tablet (highest dose) in the morning and one in the evening

Drug: BAY1128688

Placebo

PLACEBO COMPARATOR

One placebo tablet in the morning and one in the evening

Drug: Placebo

Interventions

BAY1128688 DRUG

Various dosing OD (once daily) and BID (twice daily)

BAY1128688 (dose 1); BAY1128688 (dose 2); BAY1128688 (dose 3); BAY1128688 (dose 4); BAY1128688 (dose 5)

Placebo DRUG

Matching placebo tablets

BAY1128688 (dose 1); BAY1128688 (dose 2); BAY1128688 (dose 3); Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women of at least 18 years of age at the time of signing of informed consent
• Women with endometriosis confirmed by at least one of the two criteria:
• surgery within the last 10 years
• imaging within the last 12 months
• moderate to severe pelvic pain which will be assessed over a period of 28 days
• Willingness to use only ibuprofen as rescue pain medication for endometriosis-associated pelvic pain
• Willingness to use non-hormonal barrier method for contraception (here spermicide-coated condoms) from screening visit until the end of the study (unless adequate contraception is achieved by vasectomy of the partner or use of copper intrauterine device \[IUD\] or commitment to abstinence) and refrain from using hormonal contraception

You may not qualify if:

• Pregnancy or lactation (more than three months since delivery, abortion, or lactation before start of treatment) AND no wish for pregnancy during the study
• Altered bilirubin metabolism and liver function at Visit 1
• Requirement to use pain medications for reasons other than endometriosis
• Contraindications to using ibuprofen
• Signs of hyperandrogenism
• Absence of menstrual cycles and/or abnormal vaginal/genital bleeding
• History of hysterectomy, tubal-ligation or bilateral ovariectomy
• Uncontrolled thyroid disorder

Sponsors & Collaborators

• Bayer: lead

Study Sites (68)

Medizinische Universität Graz

Graz, Styria, 8036, Austria

Location

Kepler Universitätsklinikum

Linz, Upper Austria, 4020, Austria

Location

Landeskrankenhaus - Universitätskliniken Innsbruck

Innsbruck, 6020, Austria

Location

Allgemeines Krankenhaus der Stadt Wien

Vienna, 1090, Austria

Location

AZ Jan Palfijn Gent

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

CU Saint-Luc/UZ St-Luc

Bruxelles - Brussel, 1200, Belgium

Location

Ziekenhuis Oost-Limburg

Genk, 3600, Belgium

Location

CHU de Tivoli

La Louvière, 7100, Belgium

Location

Gynekologie MEDA s.r.o.

Brno, 602 00, Czechia

Location

GYN-F s.r.o.

Hradec Králové, 500 03, Czechia

Location

G-Centrum Olomouc s.r.o. Dr. Skrivanek

Olomouc, 772 00, Czechia

Location

GynCare MUDr. Michael Svec s.r.o.

Pilsen, 326 00, Czechia

Location

Centrum gynekologicke rehabilitace

Písek, 39701, Czechia

Location

Dr. Smrhova-Kovacs

Tábor, 39003, Czechia

Location

Aarhus Universitetshospital, Skejby

Aarhus N, 8200, Denmark

Location

H:S Rigshospitalet

København Ø, DK-2100, Denmark

Location

HUS / Naistenklinikka

Helsinki, 00290, Finland

Location

Keski-Suomen keskussairaala

Jyväskylä, 40620, Finland

Location

Lääkäriasema Cantti Oy

Kuopio, 70110, Finland

Location

Lääkärikeskus Gyneko

Oulu, 90100, Finland

Location

Centre Hospitalier Universitaire - Angers

Angers, 49100, France

Location

Cochin - Paris

Paris, 75674, France

Location

Vincentius-Diakonissen-Kliniken gAG

Karlsruhe, Baden-Wurttemberg, 76199, Germany

Location

Praxisklinik am Rosengarten

Mannheim, Baden-Wurttemberg, 68165, Germany

Location

Klinikum rechts der Isar

München, Bavaria, 81675, Germany

Location

Praxis Hr. Dr. A. Gerick

Aachen, North Rhine-Westphalia, 52072, Germany

Location

Praxis Hr. Dr. S. Fiedler

Aachen, North Rhine-Westphalia, 52074, Germany

Location

Frauenarztpraxis Dr. Wolfgang Clemens

Stolberg, North Rhine-Westphalia, 52222, Germany

Location

Praxis f. Gynäkologie und Geburtshilfe

Bernburg, Saxony-Anhalt, 06406, Germany

Location

Frauenarztpraxis Dr. Wetzel

Blankenburg, Saxony-Anhalt, 38889, Germany

Location

Praxis Hr. Prof. Dr. A. Ebert

Berlin, 10787, Germany

Location

Charité Campus Benjamin Franklin (CBF)

Berlin, 12200, Germany

Location

Semmelweis University

Budapest, 1082, Hungary

Location

Semmelweis University

Budapest, 1085, Hungary

Location

Bajcsy Zsilinszky Korhaz-Rendelointezet

Budapest, 1106, Hungary

Location

Robert Karoly Magankorhaz

Budapest, 1135, Hungary

Location

NAP - Rendelo, Private Clinic

Debrecen, 4028, Hungary

Location

Debreceni Egyetem Klinikai Kozpont

Debrecen, 4032, Hungary

Location

SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont

Szeged, 6725, Hungary

Location

Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

Székesfehérvár, 8000, Hungary

Location

Casa di Cura Privata Malzoni - Villa dei Platani

Avellino, Campania, 83100, Italy

Location

A.O.U. di Bologna Policlinico S.Orsola Malpighi

Bologna, Emilia-Romagna, 40138, Italy

Location

A.S.U. Integrata di Udine

Udine, Friuli Venezia Giulia, 33100, Italy

Location

Fondazione Policlinico Universitario Agostino Gemelli

Rome, Lazio, 00168, Italy

Location

IRCCS A.O.U. San Martino IST Ist. Nazionale Ricerca Cancro

Genoa, Liguria, 16132, Italy

Location

A.O.U. Careggi

Florence, Tuscany, 50134, Italy

Location

A.O.U. Senese

Siena, Tuscany, 53100, Italy

Location

A.O.U. Integrata Verona

Verona, Veneto, 37126, Italy

Location

Flevoziekenhuis

Almere Stad, 1315 RA, Netherlands

Location

Isala

Zwolle, 8025 AB, Netherlands

Location

CLINICAL MEDICAL RESEARCH Sp. z o. o.

Katowice, 40-001, Poland

Location

Vita Longa Sp. z o.o.

Katowice, 40-748, Poland

Location

Prywatny Gabinet Lekarski Ginekologia, Poloznictwo i Ultr.

Lodz, 90-602, Poland

Location

Specjalistyczny Gabinet Ginekologiczno-Polozniczy

Lublin, 20-064, Poland

Location

NZOZ NOVITA, Specjalistyczne Gabinety Lekarskie

Lublin, 20-632, Poland

Location

VitroLive Sp. z o.o.

Szczecin, 70-483, Poland

Location

Twoja Przychodnia - Szczecinskie Centrum Medyczne

Szczecin, 71-434, Poland

Location

NZOZ Zieniewicz Medical

Warsaw, 02-201, Poland

Location

Hospital Clínic i Provincial de Barcelona

Barcelona, 08036, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario "La Paz"

Madrid, 28046, Spain

Location

Hospital Regional de Málaga

Málaga, 29010, Spain

Location

Hospital Universitario Virgen del Rocío

Seville, 41013, Spain

Location

Hospital General Universitario de Valencia

Valencia, 46014, Spain

Location

York Teaching Hospital NHS Foundation Trust

York, North Yorkshire, YO318HE, United Kingdom

Location

Liverpool Womens Hospital

Liverpool, L8 7SS, United Kingdom

Location

Norfolk and Norwich Hospital

Norwich, NR4 7UY, United Kingdom

Location

Whiston Hospital

Prescot, L35 5DR, United Kingdom

Location

Related Publications (1)

• Hilpert J, Groettrup-Wolfers E, Kosturski H, Bennett L, Barnes CLK, Gude K, Gashaw I, Reif S, Steger-Hartmann T, Scheerans C, Solms A, Rottmann A, Mao G, Chapron C. Hepatotoxicity of AKR1C3 Inhibitor BAY1128688: Findings from an Early Terminated Phase IIa Trial for the Treatment of Endometriosis. Drugs R D. 2023 Sep;23(3):221-237. doi: 10.1007/s40268-023-00427-5. Epub 2023 Jul 9.

  PMID: 37422772 DERIVED

MeSH Terms

Conditions

Endometriosis

Interventions

BAY1128688

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2017
• First Posted: December 14, 2017
• Study Start: November 30, 2017
• Primary Completion: July 23, 2018
• Study Completion: October 22, 2018
• Last Updated: October 3, 2019

Record last verified: 2019-10

Locations

BE (4); FR (2); FI (4); AU (4); GB (4); IT (8); DE (10); NL (2); CZ (6); DK (2); PL (8); ES (6); HU (8)