Trial Condition(s):

Endometriosis

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)

Bayer Identifier:

17472

ClinicalTrials.gov Identifier:

NCT03373422

EudraCT Number:

2017-000244-18

Terminated/Withdrawn

Trial Purpose

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.

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

Trial Summary

Enrollment Goal
121
Trial Dates
black-arrow
Phase
2
Could I receive a placebo?
Yes
Products
BAY1128688
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Ziekenhuis Oost-Limburg

GENK, Belgium, 3600

Status
Completed
 
Locations

AZ Jan Palfijn Gent

Gent, Belgium, 9000

Status
Completed
 
Locations

Hospital Clínic i Provincial de Barcelona

Barcelona, Spain, 08036

Status
Completed
 
Locations

Hospital Universitario Virgen del Rocío

Sevilla, Spain, 41013

Status
Completed
 
Locations

Hospital Regional de Málaga

Málaga, Spain, 29010

Status
Completed
 
Locations

Hospital Universitario 12 de Octubre

Madrid, Spain, 28041

Status
Completed
 
Locations

Hospital General Universitario de Valencia

Valencia, Spain, 46014

Status
Completed
 
Locations

Hospital Universitario "La Paz"

Madrid, Spain, 28046

Status
Completed
 
Locations

CU Saint-Luc/UZ St-Luc

BRUXELLES - BRUSSEL, Belgium, 1200

Status
Completed
 
Locations

CHU de Tivoli

LA LOUVIERE, Belgium, 7100

Status
Completed
 
Locations

Aarhus Universitetshospital, Skejby

Aarhus N, Denmark, 8200

Status
Completed
 
Locations

H:S Rigshospitalet

København Ø, Denmark, DK-2100

Status
Completed
 
Locations

Allgemeines Krankenhaus der Stadt Wien

Wien, Austria, 1090

Status
Completed
 
Locations

Medizinische Universität Graz

Graz, Austria, 8036

Status
Completed
 
Locations

Kepler Universitätsklinikum

Linz, Austria, 4020

Status
Completed
 
Locations

Landeskrankenhaus - Universitätskliniken Innsbruck

Innsbruck, Austria, 6020

Status
Completed
 
Locations

NZOZ Zieniewicz Medical

Warszawa, Poland, 02-201

Status
Completed
 
Locations

NZOZ NOVITA, Specjalistyczne Gabinety Lekarskie

Lublin, Poland, 20-632

Status
Completed
 
Locations

Prywatny Gabinet Lekarski Ginekologia, Poloznictwo i Ultr.

Lodz, Poland, 90-602

Status
Completed
 
Locations

Vita Longa Sp. z o.o.

Katowice, Poland, 40-748

Status
Completed
 
Locations

Specjalistyczny Gabinet Ginekologiczno-Polozniczy

Lublin, Poland, 20-064

Status
Completed
 
Locations

CLINICAL MEDICAL RESEARCH Sp. z o. o.

Katowice, Poland, 40-001

Status
Completed
 
Locations

VitroLive Sp. z o.o.

Szczecin, Poland, 70-483

Status
Completed
 
Locations

Twoja Przychodnia - Szczecinskie Centrum Medyczne

Szczecin, Poland, 71-434

Status
Completed
 
Locations

Centrum gynekologicke rehabilitace

Pisek, Czech Republic, 39701

Status
Completed
 
Locations

Dr. Smrhova-Kovacs

Tabor, Czech Republic, 39003

Status
Completed
 
Locations

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

Olomouc, Czech Republic, 772 00

Status
Completed
 
Locations

GYN-F s.r.o.

Hradec Kralove, Czech Republic, 500 03

Status
Completed
 
Locations

GynCare MUDr. Michael Svec s.r.o.

Plzen, Czech Republic, 326 00

Status
Completed
 
Locations

Semmelweis University

Budapest, Hungary, 1082

Status
Completed
 
Locations

Semmelweis University

Budapest, Hungary, 1085

Status
Completed
 
Locations

Debreceni Egyetem Klinikai Kozpont

Debrecen, Hungary, 4032

Status
Completed
 
Locations

SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont

Szeged, Hungary, 6725

Status
Completed
 
Locations

Robert Karoly Magankorhaz

Budapest, Hungary, 1135

Status
Completed
 
Locations

Bajcsy Zsilinszky Korhaz-Rendelointezet

Budapest, Hungary, 1106

Status
Completed
 
Locations

Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

Szekesfehervar, Hungary, 8000

Status
Completed
 
Locations

NAP - Rendelo, Private Clinic

Debrecen, Hungary, 4028

Status
Completed
 
Locations

Fondazione Policlinico Universitario Agostino Gemelli

Roma, Italy, 00168

Status
Completed
 
Locations

A.O.U. Senese

Siena, Italy, 53100

Status
Completed
 
Locations

A.O.U. Integrata Verona

Verona, Italy, 37126

Status
Completed
 
Locations

A.S.U. Integrata di Udine

Udine, Italy, 33100

Status
Completed
 
Locations

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

Bologna, Italy, 40138

Status
Completed
 
Locations

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

Genova, Italy, 16132

Status
Completed
 
Locations

Casa di Cura Privata Malzoni - Villa dei Platani

Avellino, Italy, 83100

Status
Completed
 
Locations

Norfolk and Norwich Hospital

Norwich, United Kingdom, NR4 7UY

Status
Completed
 
Locations

York Teaching Hospital NHS Foundation Trust

York, United Kingdom, YO318HE

Status
Completed
 
Locations

Flevoziekenhuis

ALMERE, Netherlands, 1315 RA

Status
Completed
 
Locations

Lääkäriasema Cantti Oy

Kuopio, Finland, 70110

Status
Completed
 
Locations

HUS / Naistenklinikka

Helsinki, Finland, 00290

Status
Completed
 
Locations

Lääkärikeskus Gyneko

Oulu, Finland, 90100

Status
Completed
 
Locations

Keski-Suomen keskussairaala

Jyväskylä, Finland, 40620

Status
Completed
 
Locations

Cochin - Paris

PARIS, France, 75674

Status
Completed
 
Locations

Centre Hospitalier Universitaire - Angers

Angers, France, 49100

Status
Completed
 
Locations

A.O.U. Careggi

Firenze, Italy, 50134

Status
Completed
 
Locations

Praxis Hr. Prof. Dr. A. Ebert

Berlin, Germany, 10787

Status
Completed
 
Locations

Praxis Hr. Dr. A. Gerick

Aachen, Germany, 52072

Status
Completed
 
Locations

Klinikum rechts der Isar

München, Germany, 81675

Status
Completed
 
Locations

Praxisklinik am Rosengarten

Mannheim, Germany, 68165

Status
Completed
 
Locations

Vincentius-Diakonissen-Kliniken gAG

Karlsruhe, Germany, 76199

Status
Completed
 
Locations

Praxis f. Gynäkologie und Geburtshilfe

Bernburg, Germany, 06406

Status
Completed
 
Locations

Charité Campus Benjamin Franklin (CBF)

Berlin, Germany, 12200

Status
Completed
 
Locations

Frauenarztpraxis Dr. Wolfgang Clemens

Stolberg, Germany, 52222

Status
Completed
 
Locations

Praxis Hr. Dr. S. Fiedler

Aachen, Germany, 52074

Status
Completed
 
Locations

Frauenarztpraxis Dr. Wetzel

Blankenburg, Germany, 38889

Status
Completed
 
Locations

Whiston Hospital

Prescot, United Kingdom, L35 5DR

Status
Completed
 
Locations

Isala

ZWOLLE, Netherlands, 8025 AB

Status
Completed
 
Locations

Liverpool Womens Hospital

Liverpool, United Kingdom, L8 7SS

Status
Completed
 
Locations

Gynekologie MEDA s.r.o.

Brno, Czech Republic, 602 00

Status
Completed
 

Trial Design