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:
EudraCT Number:
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
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Locations Ziekenhuis Oost-Limburg GENK, Belgium, 3600 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations AZ Jan Palfijn Gent Gent, Belgium, 9000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Clínic i Provincial de Barcelona Barcelona, Spain, 08036 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Universitario Virgen del Rocío Sevilla, Spain, 41013 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Regional de Málaga Málaga, Spain, 29010 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Universitario 12 de Octubre Madrid, Spain, 28041 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital General Universitario de Valencia Valencia, Spain, 46014 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Universitario "La Paz" Madrid, Spain, 28046 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations CU Saint-Luc/UZ St-Luc BRUXELLES - BRUSSEL, Belgium, 1200 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations CHU de Tivoli LA LOUVIERE, Belgium, 7100 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Aarhus Universitetshospital, Skejby Aarhus N, Denmark, 8200 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations H:S Rigshospitalet København Ø, Denmark, DK-2100 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Allgemeines Krankenhaus der Stadt Wien Wien, Austria, 1090 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Medizinische Universität Graz Graz, Austria, 8036 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kepler Universitätsklinikum Linz, Austria, 4020 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Landeskrankenhaus - Universitätskliniken Innsbruck Innsbruck, Austria, 6020 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations NZOZ Zieniewicz Medical Warszawa, Poland, 02-201 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations NZOZ NOVITA, Specjalistyczne Gabinety Lekarskie Lublin, Poland, 20-632 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Prywatny Gabinet Lekarski Ginekologia, Poloznictwo i Ultr. Lodz, Poland, 90-602 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Vita Longa Sp. z o.o. Katowice, Poland, 40-748 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Specjalistyczny Gabinet Ginekologiczno-Polozniczy Lublin, Poland, 20-064 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations CLINICAL MEDICAL RESEARCH Sp. z o. o. Katowice, Poland, 40-001 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations VitroLive Sp. z o.o. Szczecin, Poland, 70-483 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Twoja Przychodnia - Szczecinskie Centrum Medyczne Szczecin, Poland, 71-434 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centrum gynekologicke rehabilitace Pisek, Czech Republic, 39701 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Dr. Smrhova-Kovacs Tabor, Czech Republic, 39003 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations G-Centrum Olomouc s.r.o. Dr. Skrivanek Olomouc, Czech Republic, 772 00 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations GYN-F s.r.o. Hradec Kralove, Czech Republic, 500 03 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations GynCare MUDr. Michael Svec s.r.o. Plzen, Czech Republic, 326 00 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Semmelweis University Budapest, Hungary, 1082 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Semmelweis University Budapest, Hungary, 1085 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Debreceni Egyetem Klinikai Kozpont Debrecen, Hungary, 4032 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont Szeged, Hungary, 6725 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Robert Karoly Magankorhaz Budapest, Hungary, 1135 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Bajcsy Zsilinszky Korhaz-Rendelointezet Budapest, Hungary, 1106 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz Szekesfehervar, Hungary, 8000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations NAP - Rendelo, Private Clinic Debrecen, Hungary, 4028 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fondazione Policlinico Universitario Agostino Gemelli Roma, Italy, 00168 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations A.O.U. Senese Siena, Italy, 53100 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations A.O.U. Integrata Verona Verona, Italy, 37126 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations A.S.U. Integrata di Udine Udine, Italy, 33100 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations A.O.U. di Bologna Policlinico S.Orsola Malpighi Bologna, Italy, 40138 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations IRCCS A.O.U. San Martino IST Ist. Nazionale Ricerca Cancro Genova, Italy, 16132 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Casa di Cura Privata Malzoni - Villa dei Platani Avellino, Italy, 83100 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Norfolk and Norwich Hospital Norwich, United Kingdom, NR4 7UY | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations York Teaching Hospital NHS Foundation Trust York, United Kingdom, YO318HE | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Flevoziekenhuis ALMERE, Netherlands, 1315 RA | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Lääkäriasema Cantti Oy Kuopio, Finland, 70110 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations HUS / Naistenklinikka Helsinki, Finland, 00290 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Lääkärikeskus Gyneko Oulu, Finland, 90100 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Keski-Suomen keskussairaala Jyväskylä, Finland, 40620 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Cochin - Paris PARIS, France, 75674 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centre Hospitalier Universitaire - Angers Angers, France, 49100 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations A.O.U. Careggi Firenze, Italy, 50134 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Praxis Hr. Prof. Dr. A. Ebert Berlin, Germany, 10787 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Praxis Hr. Dr. A. Gerick Aachen, Germany, 52072 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Klinikum rechts der Isar München, Germany, 81675 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Praxisklinik am Rosengarten Mannheim, Germany, 68165 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Vincentius-Diakonissen-Kliniken gAG Karlsruhe, Germany, 76199 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Praxis f. Gynäkologie und Geburtshilfe Bernburg, Germany, 06406 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Charité Campus Benjamin Franklin (CBF) Berlin, Germany, 12200 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Frauenarztpraxis Dr. Wolfgang Clemens Stolberg, Germany, 52222 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Praxis Hr. Dr. S. Fiedler Aachen, Germany, 52074 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Frauenarztpraxis Dr. Wetzel Blankenburg, Germany, 38889 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Whiston Hospital Prescot, United Kingdom, L35 5DR | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Isala ZWOLLE, Netherlands, 8025 AB | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Liverpool Womens Hospital Liverpool, United Kingdom, L8 7SS | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Gynekologie MEDA s.r.o. Brno, Czech Republic, 602 00 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
N/A
Assignment:
Parallel Assignment
Trial Arms:
6
Primary Outcome
- 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)Timeframe: 12 weeks
Secondary Outcome
- Incidence of treatment-emergent adverse eventsTimeframe: 18 weeks
Additional Information
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