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 (AKRENDO1)

A Randomized, Placebo-controlled, Double-blind, Parallel-group, Multi-center, Exploratory Dose-response Study to Assess the Efficacy and Safety of Different Oral Doses of BAY1128688 in Women With Symptomatic Endometriosis Over a 12-week Treatment Period

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.

Study Overview

• Status: Terminated
• Conditions: Endometriosis
• Intervention / Treatment: Drug: Placebo; Drug: BAY1128688

• Study Type: Interventional
• Enrollment (Actual): 121
• Phase: Phase 2

Contacts and Locations

Study Locations

• Austria
  • Innsbruck, Austria, 6020
    • Landeskrankenhaus - Universitätskliniken Innsbruck
  • Wien, Austria, 1090
    • Allgemeines Krankenhaus der Stadt Wien
  • Oberösterreich
    • Linz, Oberösterreich, Austria, 4020
      • Kepler Universitätsklinikum
  • Steiermark
    • Graz, Steiermark, Austria, 8036
      • Medizinische Universität Graz
• Belgium
  • Bruxelles - Brussel, Belgium, 1200
    • CU Saint-Luc/UZ St-Luc
  • Genk, Belgium, 3600
    • Ziekenhuis Oost-Limburg
  • La Louviere, Belgium, 7100
    • CHU de Tivoli
  • Oost-Vlaanderen
    • Gent, Oost-Vlaanderen, Belgium, 9000
      • AZ Jan Palfijn Gent
• Czechia
  • Brno, Czechia, 602 00
    • Gynekologie MEDA s.r.o.
  • Hradec Kralove, Czechia, 500 03
    • GYN-F s.r.o.
  • Olomouc, Czechia, 772 00
    • G-Centrum Olomouc s.r.o. Dr. Skrivanek
  • Pisek, Czechia, 39701
    • Centrum gynekologicke rehabilitace
  • Plzen, Czechia, 326 00
    • Gyncare MUDr. Michael Švec s.r.o.
  • Tabor, Czechia, 39003
    • Dr. Smrhova-Kovacs
• Denmark
  • Aarhus N, Denmark, 8200
    • Aarhus Universitetshospital, Skejby
  • København Ø, Denmark, DK-2100
    • H:S Rigshospitalet
• Finland
  • Helsinki, Finland, 00290
    • HUS / Naistenklinikka
  • Jyväskylä, Finland, 40620
    • Keski-Suomen Keskussairaala
  • Kuopio, Finland, 70110
    • Lääkäriasema Cantti Oy
  • Oulu, Finland, 90100
    • Lääkärikeskus Gyneko
• France
  • Angers, France, 49100
    • Centre Hospitalier Universitaire - Angers
  • Paris, France, 75674
    • Cochin - Paris
• Germany
  • Berlin, Germany, 10787
    • Praxis Hr. Prof. Dr. A. Ebert
  • Berlin, Germany, 12200
    • Charité Campus Benjamin Franklin (CBF)
  • Baden-Württemberg
    • Karlsruhe, Baden-Württemberg, Germany, 76199
      • Vincentius-Diakonissen-Kliniken gAG
    • Mannheim, Baden-Württemberg, Germany, 68165
      • Praxisklinik am Rosengarten
  • Bayern
    • München, Bayern, Germany, 81675
      • Klinikum rechts der Isar
  • Nordrhein-Westfalen
    • Aachen, Nordrhein-Westfalen, Germany, 52072
      • Praxis Hr. Dr. A. Gerick
    • Aachen, Nordrhein-Westfalen, Germany, 52074
      • Praxis Hr. Dr. S. Fiedler
    • Stolberg, Nordrhein-Westfalen, Germany, 52222
      • Frauenarztpraxis Dr. Wolfgang Clemens
  • Sachsen-Anhalt
    • Bernburg, Sachsen-Anhalt, Germany, 06406
      • Praxis f. Gynäkologie und Geburtshilfe
    • Blankenburg, Sachsen-Anhalt, Germany, 38889
      • Frauenarztpraxis Dr. Wetzel
• Hungary
  • Budapest, Hungary, 1085
    • Semmelweis University
  • Budapest, Hungary, 1082
    • Semmelweis University
  • Budapest, Hungary, 1106
    • Bajcsy Zsilinszky Korhaz-Rendelointezet
  • Budapest, Hungary, 1135
    • Robert Karoly Magankorhaz
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem Klinikai Kozpont
  • Debrecen, Hungary, 4028
    • NAP - Rendelo, Private Clinic
  • Szeged, Hungary, 6725
    • SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont
  • Szekesfehervar, Hungary, 8000
    • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
• Italy
  • Campania
    • Avellino, Campania, Italy, 83100
      • Casa di Cura Privata Malzoni - Villa dei Platani
  • Emilia-Romagna
    • Bologna, Emilia-Romagna, Italy, 40138
      • A.O.U. di Bologna Policlinico S.Orsola Malpighi
  • Friuli-Venezia Giulia
    • Udine, Friuli-Venezia Giulia, Italy, 33100
      • A.S.U. Integrata di Udine
  • Lazio
    • Roma, Lazio, Italy, 00168
      • Fondazione Policlinico Universitario Agostino Gemelli
  • Liguria
    • Genova, Liguria, Italy, 16132
      • IRCCS A.O.U. San Martino IST Ist. Nazionale Ricerca Cancro
  • Toscana
    • Firenze, Toscana, Italy, 50134
      • A.O.U. Careggi
    • Siena, Toscana, Italy, 53100
      • A.O.U. Senese
  • Veneto
    • Verona, Veneto, Italy, 37126
      • A.O.U. Integrata Verona
• Netherlands
  • Almere, Netherlands, 1315 RA
    • Flevoziekenhuis
  • Zwolle, Netherlands, 8025 AB
    • Isala
• Poland
  • Katowice, Poland, 40-748
    • Vita Longa Sp. z o.o.
  • Katowice, Poland, 40-001
    • CLINICAL MEDICAL RESEARCH Sp. z o. o.
  • Lodz, Poland, 90-602
    • Prywatny Gabinet Lekarski Ginekologia, Poloznictwo i Ultr.
  • Lublin, Poland, 20-064
    • Specjalistyczny Gabinet Ginekologiczno-Polozniczy
  • Lublin, Poland, 20-632
    • NZOZ NOVITA, Specjalistyczne Gabinety Lekarskie
  • Szczecin, Poland, 71-434
    • Twoja Przychodnia - Szczecinskie Centrum Medyczne
  • Szczecin, Poland, 70-483
    • VitroLive Sp. z o.o.
  • Warszawa, Poland, 02-201
    • Nzoz Zieniewicz Medical
• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic i Provincial de Barcelona
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain, 28046
    • Hospital Universitario "La Paz"
  • Málaga, Spain, 29010
    • Hospital Regional De Malaga
  • Sevilla, Spain, 41013
    • Hospital Universitario Virgen del Rocío
  • Valencia, Spain, 46014
    • Hospital General Universitario de Valencia
• United Kingdom
  • Liverpool, United Kingdom, L8 7SS
    • Liverpool Womens Hospital
  • Norwich, United Kingdom, NR4 7UY
    • Norfolk and Norwich Hospital
  • Prescot, United Kingdom, L35 5DR
    • Whiston Hospital
  • North Yorkshire
    • York, North Yorkshire, United Kingdom, YO318HE
      • York Teaching Hospital NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BAY1128688 (dose 1); One BAY1128688 tablet (lowest dose) in the morning, one placebo tablet in the evening	Drug: Placebo; Matching placebo tablets; Drug: BAY1128688; Various dosing OD (once daily) and BID (twice daily)
Experimental: BAY1128688 (dose 2); One BAY1128688 tablet (first intermediate dose) in the morning, one placebo tablet in the evening	Drug: Placebo; Matching placebo tablets; Drug: BAY1128688; Various dosing OD (once daily) and BID (twice daily)
Experimental: BAY1128688 (dose 3); One BAY1128688 tablet (second intermediate dose) in the morning, one placebo tablet in the evening	Drug: Placebo; Matching placebo tablets; Drug: BAY1128688; Various dosing OD (once daily) and BID (twice daily)
Experimental: BAY1128688 (dose 4); One BAY1128688 tablet (second intermediate dose) in the morning and one in the evening	Drug: BAY1128688; Various dosing OD (once daily) and BID (twice daily)
Experimental: BAY1128688 (dose 5); One BAY1128688 tablet (highest dose) in the morning and one in the evening	Drug: BAY1128688; Various dosing OD (once daily) and BID (twice daily)
Placebo Comparator: Placebo; One placebo tablet in the morning and one in the evening	Drug: Placebo; Matching placebo tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Incidence of treatment-emergent adverse events	18 weeks

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2017
• Primary Completion (Actual): July 23, 2018
• Study Completion (Actual): October 22, 2018

Study Registration Dates

• First Submitted: November 23, 2017
• First Submitted That Met QC Criteria: December 13, 2017
• First Posted (Actual): December 14, 2017

Study Record Updates

• Last Update Posted (Actual): October 3, 2019
• Last Update Submitted That Met QC Criteria: October 2, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endometriosis
• Other Study ID Numbers: 17472; 2017-000244-18 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No