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
- Conditions
- Endometriosis
- Interventions
- Drug: BAY1128688Drug: Placebo
- Registration Number
- NCT03373422
- Lead Sponsor
- Bayer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 121
-
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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BAY1128688 (dose 3) Placebo One BAY1128688 tablet (second intermediate dose) in the morning, one placebo tablet in the evening BAY1128688 (dose 2) BAY1128688 One BAY1128688 tablet (first intermediate dose) in the morning, one placebo tablet in the evening BAY1128688 (dose 3) BAY1128688 One BAY1128688 tablet (second intermediate dose) in the morning, one placebo tablet in the evening BAY1128688 (dose 4) BAY1128688 One BAY1128688 tablet (second intermediate dose) in the morning and one in the evening BAY1128688 (dose 1) Placebo One BAY1128688 tablet (lowest dose) in the morning, one placebo tablet in the evening BAY1128688 (dose 5) BAY1128688 One BAY1128688 tablet (highest dose) in the morning and one in the evening Placebo Placebo One placebo tablet in the morning and one in the evening BAY1128688 (dose 1) BAY1128688 One BAY1128688 tablet (lowest dose) in the morning, one placebo tablet in the evening BAY1128688 (dose 2) Placebo One BAY1128688 tablet (first intermediate dose) in the morning, one placebo tablet in the evening
- Primary Outcome Measures
Name Time Method 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) 12 weeks EAPP: endometriosis-associated pelvic pain, measured on the NRS (Numerical Rating Scale) by item 1 of the ESD (Endometriosis Symptom Diary)
- Secondary Outcome Measures
Name Time Method Incidence of treatment-emergent adverse events 18 weeks
Trial Locations
- Locations (67)
Kepler Universitätsklinikum
🇦🇹Linz, Oberösterreich, Austria
Medizinische Universität Graz
🇦🇹Graz, Steiermark, Austria
Landeskrankenhaus - Universitätskliniken Innsbruck
🇦🇹Innsbruck, Austria
Allgemeines Krankenhaus der Stadt Wien
🇦🇹Wien, Austria
AZ Jan Palfijn Gent
🇧🇪Gent, Oost-Vlaanderen, Belgium
Lääkäriasema Cantti Oy
🇫🇮Kuopio, Finland
Fondazione Policlinico Universitario Agostino Gemelli
🇮🇹Roma, Lazio, Italy
Isala
🇳🇱Zwolle, Netherlands
CLINICAL MEDICAL RESEARCH Sp. z o. o.
🇵🇱Katowice, Poland
Vita Longa Sp. z o.o.
🇵🇱Katowice, Poland
Prywatny Gabinet Lekarski Ginekologia, Poloznictwo i Ultr.
🇵🇱Lodz, Poland
Debreceni Egyetem Klinikai Kozpont
🇭🇺Debrecen, Hungary
Bajcsy Zsilinszky Korhaz-Rendelointezet
🇭🇺Budapest, Hungary
NAP - Rendelo, Private Clinic
🇭🇺Debrecen, Hungary
SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont
🇭🇺Szeged, Hungary
A.O.U. Integrata Verona
🇮🇹Verona, Veneto, Italy
NZOZ Zieniewicz Medical
🇵🇱Warszawa, Poland
Praxis Hr. Dr. S. Fiedler
🇩🇪Aachen, Nordrhein-Westfalen, Germany
Praxis f. Gynäkologie und Geburtshilfe
🇩🇪Bernburg, Sachsen-Anhalt, Germany
A.S.U. Integrata di Udine
🇮🇹Udine, Friuli-Venezia Giulia, Italy
Semmelweis University
🇭🇺Budapest, Hungary
Klinikum rechts der Isar
🇩🇪München, Bayern, Germany
Frauenarztpraxis Dr. Wetzel
🇩🇪Blankenburg, Sachsen-Anhalt, Germany
Lääkärikeskus Gyneko
🇫🇮Oulu, Finland
Centre Hospitalier Universitaire - Angers
🇫🇷Angers, France
Cochin - Paris
🇫🇷Paris, France
Praxis Hr. Prof. Dr. A. Ebert
🇩🇪Berlin, Germany
Flevoziekenhuis
🇳🇱Almere, Netherlands
Vincentius-Diakonissen-Kliniken gAG
🇩🇪Karlsruhe, Baden-Württemberg, Germany
Praxisklinik am Rosengarten
🇩🇪Mannheim, Baden-Württemberg, Germany
Robert Karoly Magankorhaz
🇭🇺Budapest, Hungary
Praxis Hr. Dr. A. Gerick
🇩🇪Aachen, Nordrhein-Westfalen, Germany
Frauenarztpraxis Dr. Wolfgang Clemens
🇩🇪Stolberg, Nordrhein-Westfalen, Germany
VitroLive Sp. z o.o.
🇵🇱Szczecin, Poland
Liverpool Womens Hospital
🇬🇧Liverpool, United Kingdom
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Charité Campus Benjamin Franklin (CBF)
🇩🇪Berlin, Germany
NZOZ NOVITA, Specjalistyczne Gabinety Lekarskie
🇵🇱Lublin, Poland
Casa di Cura Privata Malzoni - Villa dei Platani
🇮🇹Avellino, Campania, Italy
A.O.U. di Bologna Policlinico S.Orsola Malpighi
🇮🇹Bologna, Emilia-Romagna, Italy
A.O.U. Senese
🇮🇹Siena, Toscana, Italy
Centrum gynekologicke rehabilitace
🇨🇿Pisek, Czechia
GynCare MUDr. Michael Svec s.r.o.
🇨🇿Plzen, Czechia
CHU de Tivoli
🇧🇪La Louviere, Belgium
Ziekenhuis Oost-Limburg
🇧🇪Genk, Belgium
CU Saint-Luc/UZ St-Luc
🇧🇪Bruxelles - Brussel, Belgium
GYN-F s.r.o.
🇨🇿Hradec Kralove, Czechia
Gynekologie MEDA s.r.o.
🇨🇿Brno, Czechia
G-Centrum Olomouc s.r.o. Dr. Skrivanek
🇨🇿Olomouc, Czechia
Dr. Smrhova-Kovacs
🇨🇿Tabor, Czechia
Aarhus Universitetshospital, Skejby
🇩🇰Aarhus N, Denmark
H:S Rigshospitalet
🇩🇰København Ø, Denmark
HUS / Naistenklinikka
🇫🇮Helsinki, Finland
Keski-Suomen keskussairaala
🇫🇮Jyväskylä, Finland
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
🇭🇺Szekesfehervar, Hungary
A.O.U. Careggi
🇮🇹Firenze, Toscana, Italy
IRCCS A.O.U. San Martino IST Ist. Nazionale Ricerca Cancro
🇮🇹Genova, Liguria, Italy
Specjalistyczny Gabinet Ginekologiczno-Polozniczy
🇵🇱Lublin, Poland
Twoja Przychodnia - Szczecinskie Centrum Medyczne
🇵🇱Szczecin, Poland
Hospital Clínic i Provincial de Barcelona
🇪🇸Barcelona, Spain
Hospital Universitario "La Paz"
🇪🇸Madrid, Spain
Hospital Regional de Málaga
🇪🇸Málaga, Spain
Norfolk and Norwich Hospital
🇬🇧Norwich, United Kingdom
Whiston Hospital
🇬🇧Prescot, United Kingdom
Hospital General Universitario de Valencia
🇪🇸Valencia, Spain
Hospital Universitario Virgen del Rocío
🇪🇸Sevilla, Spain
York Teaching Hospital NHS Foundation Trust
🇬🇧York, North Yorkshire, United Kingdom