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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)

Primary Purpose

Endometriosis

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BAY1128688
Placebo
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometriosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Kepler Universitätsklinikum
  • Medizinische Universität Graz
  • Landeskrankenhaus - Universitätskliniken Innsbruck
  • Allgemeines Krankenhaus der Stadt Wien
  • AZ Jan Palfijn Gent
  • CU Saint-Luc/UZ St-Luc
  • Ziekenhuis Oost-Limburg
  • CHU de Tivoli
  • Gynekologie MEDA s.r.o.
  • GYN-F s.r.o.
  • G-Centrum Olomouc s.r.o. Dr. Skrivanek
  • Centrum gynekologicke rehabilitace
  • GynCare MUDr. Michael Svec s.r.o.
  • Dr. Smrhova-Kovacs
  • Aarhus Universitetshospital, Skejby
  • H:S Rigshospitalet
  • HUS / Naistenklinikka
  • Keski-Suomen keskussairaala
  • Lääkäriasema Cantti Oy
  • Lääkärikeskus Gyneko
  • Centre Hospitalier Universitaire - Angers
  • Cochin - Paris
  • Vincentius-Diakonissen-Kliniken gAG
  • Praxisklinik am Rosengarten
  • Klinikum rechts der Isar
  • Praxis Hr. Dr. A. Gerick
  • Praxis Hr. Dr. S. Fiedler
  • Frauenarztpraxis Dr. Wolfgang Clemens
  • Praxis f. Gynäkologie und Geburtshilfe
  • Frauenarztpraxis Dr. Wetzel
  • Praxis Hr. Prof. Dr. A. Ebert
  • Charité Campus Benjamin Franklin (CBF)
  • Semmelweis University
  • Semmelweis University
  • Bajcsy Zsilinszky Korhaz-Rendelointezet
  • Robert Karoly Magankorhaz
  • NAP - Rendelo, Private Clinic
  • Debreceni Egyetem Klinikai Kozpont
  • SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont
  • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
  • Casa di Cura Privata Malzoni - Villa dei Platani
  • A.O.U. di Bologna Policlinico S.Orsola Malpighi
  • A.S.U. Integrata di Udine
  • Fondazione Policlinico Universitario Agostino Gemelli
  • IRCCS A.O.U. San Martino IST Ist. Nazionale Ricerca Cancro
  • A.O.U. Careggi
  • A.O.U. Senese
  • A.O.U. Integrata Verona
  • Flevoziekenhuis
  • Isala
  • CLINICAL MEDICAL RESEARCH Sp. z o. o.
  • Vita Longa Sp. z o.o.
  • Prywatny Gabinet Lekarski Ginekologia, Poloznictwo i Ultr.
  • Specjalistyczny Gabinet Ginekologiczno-Polozniczy
  • NZOZ NOVITA, Specjalistyczne Gabinety Lekarskie
  • VitroLive Sp. z o.o.
  • Twoja Przychodnia - Szczecinskie Centrum Medyczne
  • NZOZ Zieniewicz Medical
  • Hospital Clínic i Provincial de Barcelona
  • Hospital Universitario 12 de Octubre
  • Hospital Universitario "La Paz"
  • Hospital Regional de Málaga
  • Hospital Universitario Virgen del Rocío
  • Hospital General Universitario de Valencia
  • York Teaching Hospital NHS Foundation Trust
  • Liverpool Womens Hospital
  • Norfolk and Norwich Hospital
  • Whiston Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

BAY1128688 (dose 1)

BAY1128688 (dose 2)

BAY1128688 (dose 3)

BAY1128688 (dose 4)

BAY1128688 (dose 5)

Placebo

Arm Description

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

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

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

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

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

One placebo tablet in the morning and one in the evening

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Incidence of treatment-emergent adverse events

Full Information

First Posted
November 23, 2017
Last Updated
October 2, 2019
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT03373422
Brief Title
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
Acronym
AKRENDO1
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Terminated
Why Stopped
Study BAY1128688/17472 (AKRENDO 1) was terminated early on 20 July 2018 due to hepatotoxicity
Study Start Date
November 30, 2017 (Actual)
Primary Completion Date
July 23, 2018 (Actual)
Study Completion Date
October 22, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
121 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BAY1128688 (dose 1)
Arm Type
Experimental
Arm Description
One BAY1128688 tablet (lowest dose) in the morning, one placebo tablet in the evening
Arm Title
BAY1128688 (dose 2)
Arm Type
Experimental
Arm Description
One BAY1128688 tablet (first intermediate dose) in the morning, one placebo tablet in the evening
Arm Title
BAY1128688 (dose 3)
Arm Type
Experimental
Arm Description
One BAY1128688 tablet (second intermediate dose) in the morning, one placebo tablet in the evening
Arm Title
BAY1128688 (dose 4)
Arm Type
Experimental
Arm Description
One BAY1128688 tablet (second intermediate dose) in the morning and one in the evening
Arm Title
BAY1128688 (dose 5)
Arm Type
Experimental
Arm Description
One BAY1128688 tablet (highest dose) in the morning and one in the evening
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
One placebo tablet in the morning and one in the evening
Intervention Type
Drug
Intervention Name(s)
BAY1128688
Intervention Description
Various dosing OD (once daily) and BID (twice daily)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo tablets
Primary Outcome Measure Information:
Title
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)
Description
EAPP: endometriosis-associated pelvic pain, measured on the NRS (Numerical Rating Scale) by item 1 of the ESD (Endometriosis Symptom Diary)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Incidence of treatment-emergent adverse events
Time Frame
18 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
Facility Name
Kepler Universitätsklinikum
City
Linz
State/Province
Oberösterreich
ZIP/Postal Code
4020
Country
Austria
Facility Name
Medizinische Universität Graz
City
Graz
State/Province
Steiermark
ZIP/Postal Code
8036
Country
Austria
Facility Name
Landeskrankenhaus - Universitätskliniken Innsbruck
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Allgemeines Krankenhaus der Stadt Wien
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
AZ Jan Palfijn Gent
City
Gent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Facility Name
CU Saint-Luc/UZ St-Luc
City
Bruxelles - Brussel
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Ziekenhuis Oost-Limburg
City
Genk
ZIP/Postal Code
3600
Country
Belgium
Facility Name
CHU de Tivoli
City
La Louviere
ZIP/Postal Code
7100
Country
Belgium
Facility Name
Gynekologie MEDA s.r.o.
City
Brno
ZIP/Postal Code
602 00
Country
Czechia
Facility Name
GYN-F s.r.o.
City
Hradec Kralove
ZIP/Postal Code
500 03
Country
Czechia
Facility Name
G-Centrum Olomouc s.r.o. Dr. Skrivanek
City
Olomouc
ZIP/Postal Code
772 00
Country
Czechia
Facility Name
Centrum gynekologicke rehabilitace
City
Pisek
ZIP/Postal Code
39701
Country
Czechia
Facility Name
GynCare MUDr. Michael Svec s.r.o.
City
Plzen
ZIP/Postal Code
326 00
Country
Czechia
Facility Name
Dr. Smrhova-Kovacs
City
Tabor
ZIP/Postal Code
39003
Country
Czechia
Facility Name
Aarhus Universitetshospital, Skejby
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
Facility Name
H:S Rigshospitalet
City
København Ø
ZIP/Postal Code
DK-2100
Country
Denmark
Facility Name
HUS / Naistenklinikka
City
Helsinki
ZIP/Postal Code
00290
Country
Finland
Facility Name
Keski-Suomen keskussairaala
City
Jyväskylä
ZIP/Postal Code
40620
Country
Finland
Facility Name
Lääkäriasema Cantti Oy
City
Kuopio
ZIP/Postal Code
70110
Country
Finland
Facility Name
Lääkärikeskus Gyneko
City
Oulu
ZIP/Postal Code
90100
Country
Finland
Facility Name
Centre Hospitalier Universitaire - Angers
City
Angers
ZIP/Postal Code
49100
Country
France
Facility Name
Cochin - Paris
City
Paris
ZIP/Postal Code
75674
Country
France
Facility Name
Vincentius-Diakonissen-Kliniken gAG
City
Karlsruhe
State/Province
Baden-Württemberg
ZIP/Postal Code
76199
Country
Germany
Facility Name
Praxisklinik am Rosengarten
City
Mannheim
State/Province
Baden-Württemberg
ZIP/Postal Code
68165
Country
Germany
Facility Name
Klinikum rechts der Isar
City
München
State/Province
Bayern
ZIP/Postal Code
81675
Country
Germany
Facility Name
Praxis Hr. Dr. A. Gerick
City
Aachen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
52072
Country
Germany
Facility Name
Praxis Hr. Dr. S. Fiedler
City
Aachen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Frauenarztpraxis Dr. Wolfgang Clemens
City
Stolberg
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
52222
Country
Germany
Facility Name
Praxis f. Gynäkologie und Geburtshilfe
City
Bernburg
State/Province
Sachsen-Anhalt
ZIP/Postal Code
06406
Country
Germany
Facility Name
Frauenarztpraxis Dr. Wetzel
City
Blankenburg
State/Province
Sachsen-Anhalt
ZIP/Postal Code
38889
Country
Germany
Facility Name
Praxis Hr. Prof. Dr. A. Ebert
City
Berlin
ZIP/Postal Code
10787
Country
Germany
Facility Name
Charité Campus Benjamin Franklin (CBF)
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Facility Name
Semmelweis University
City
Budapest
ZIP/Postal Code
1082
Country
Hungary
Facility Name
Semmelweis University
City
Budapest
ZIP/Postal Code
1085
Country
Hungary
Facility Name
Bajcsy Zsilinszky Korhaz-Rendelointezet
City
Budapest
ZIP/Postal Code
1106
Country
Hungary
Facility Name
Robert Karoly Magankorhaz
City
Budapest
ZIP/Postal Code
1135
Country
Hungary
Facility Name
NAP - Rendelo, Private Clinic
City
Debrecen
ZIP/Postal Code
4028
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Kozpont
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont
City
Szeged
ZIP/Postal Code
6725
Country
Hungary
Facility Name
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
City
Szekesfehervar
ZIP/Postal Code
8000
Country
Hungary
Facility Name
Casa di Cura Privata Malzoni - Villa dei Platani
City
Avellino
State/Province
Campania
ZIP/Postal Code
83100
Country
Italy
Facility Name
A.O.U. di Bologna Policlinico S.Orsola Malpighi
City
Bologna
State/Province
Emilia-Romagna
ZIP/Postal Code
40138
Country
Italy
Facility Name
A.S.U. Integrata di Udine
City
Udine
State/Province
Friuli-Venezia Giulia
ZIP/Postal Code
33100
Country
Italy
Facility Name
Fondazione Policlinico Universitario Agostino Gemelli
City
Roma
State/Province
Lazio
ZIP/Postal Code
00168
Country
Italy
Facility Name
IRCCS A.O.U. San Martino IST Ist. Nazionale Ricerca Cancro
City
Genova
State/Province
Liguria
ZIP/Postal Code
16132
Country
Italy
Facility Name
A.O.U. Careggi
City
Firenze
State/Province
Toscana
ZIP/Postal Code
50134
Country
Italy
Facility Name
A.O.U. Senese
City
Siena
State/Province
Toscana
ZIP/Postal Code
53100
Country
Italy
Facility Name
A.O.U. Integrata Verona
City
Verona
State/Province
Veneto
ZIP/Postal Code
37126
Country
Italy
Facility Name
Flevoziekenhuis
City
Almere
ZIP/Postal Code
1315 RA
Country
Netherlands
Facility Name
Isala
City
Zwolle
ZIP/Postal Code
8025 AB
Country
Netherlands
Facility Name
CLINICAL MEDICAL RESEARCH Sp. z o. o.
City
Katowice
ZIP/Postal Code
40-001
Country
Poland
Facility Name
Vita Longa Sp. z o.o.
City
Katowice
ZIP/Postal Code
40-748
Country
Poland
Facility Name
Prywatny Gabinet Lekarski Ginekologia, Poloznictwo i Ultr.
City
Lodz
ZIP/Postal Code
90-602
Country
Poland
Facility Name
Specjalistyczny Gabinet Ginekologiczno-Polozniczy
City
Lublin
ZIP/Postal Code
20-064
Country
Poland
Facility Name
NZOZ NOVITA, Specjalistyczne Gabinety Lekarskie
City
Lublin
ZIP/Postal Code
20-632
Country
Poland
Facility Name
VitroLive Sp. z o.o.
City
Szczecin
ZIP/Postal Code
70-483
Country
Poland
Facility Name
Twoja Przychodnia - Szczecinskie Centrum Medyczne
City
Szczecin
ZIP/Postal Code
71-434
Country
Poland
Facility Name
NZOZ Zieniewicz Medical
City
Warszawa
ZIP/Postal Code
02-201
Country
Poland
Facility Name
Hospital Clínic i Provincial de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario "La Paz"
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Regional de Málaga
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocío
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital General Universitario de Valencia
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
York Teaching Hospital NHS Foundation Trust
City
York
State/Province
North Yorkshire
ZIP/Postal Code
YO318HE
Country
United Kingdom
Facility Name
Liverpool Womens Hospital
City
Liverpool
ZIP/Postal Code
L8 7SS
Country
United Kingdom
Facility Name
Norfolk and Norwich Hospital
City
Norwich
ZIP/Postal Code
NR4 7UY
Country
United Kingdom
Facility Name
Whiston Hospital
City
Prescot
ZIP/Postal Code
L35 5DR
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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