Clinical trial NCT03373422: 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
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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Endometriosis
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2017-12-14
Enrollment: 121
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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)
timeFrame: 12 weeks
Secondary outcomes:
measure: Incidence of treatment-emergent adverse events
timeFrame: 18 weeks
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Kepler Universitätsklinikum
state: Oberösterreich
city: Graz
country: Austria
facility: Medizinische Universität Graz
state: Steiermark
city: Innsbruck
country: Austria
facility: Landeskrankenhaus - Universitätskliniken Innsbruck
city: Wien
country: Austria
facility: Allgemeines Krankenhaus der Stadt Wien
city: Gent
country: Belgium
facility: AZ Jan Palfijn Gent
state: Oost-Vlaanderen
city: Bruxelles - Brussel
country: Belgium
facility: CU Saint-Luc/UZ St-Luc
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
city: La Louviere
country: Belgium
facility: CHU de Tivoli
city: Brno
country: Czechia
facility: Gynekologie MEDA s.r.o.
city: Hradec Kralove
country: Czechia
facility: GYN-F s.r.o.
city: Olomouc
country: Czechia
facility: G-Centrum Olomouc s.r.o. Dr. Skrivanek
city: Pisek
country: Czechia
facility: Centrum gynekologicke rehabilitace
city: Plzen
country: Czechia
facility: GynCare MUDr. Michael Svec s.r.o.
city: Tabor
country: Czechia
facility: Dr. Smrhova-Kovacs
city: Aarhus N
country: Denmark
facility: Aarhus Universitetshospital, Skejby
city: København Ø
country: Denmark
facility: H:S Rigshospitalet
city: Helsinki
country: Finland
facility: HUS / Naistenklinikka
city: Jyväskylä
country: Finland
facility: Keski-Suomen keskussairaala
city: Kuopio
country: Finland
facility: Lääkäriasema Cantti Oy
city: Oulu
country: Finland
facility: Lääkärikeskus Gyneko
city: Angers
country: France
facility: Centre Hospitalier Universitaire - Angers
city: Paris
country: France
facility: Cochin - Paris
city: Karlsruhe
country: Germany
facility: Vincentius-Diakonissen-Kliniken gAG
state: Baden-Württemberg
city: Mannheim
country: Germany
facility: Praxisklinik am Rosengarten
state: Baden-Württemberg
city: München
country: Germany
facility: Klinikum rechts der Isar
state: Bayern
city: Aachen
country: Germany
facility: Praxis Hr. Dr. A. Gerick
state: Nordrhein-Westfalen
city: Aachen
country: Germany
facility: Praxis Hr. Dr. S. Fiedler
state: Nordrhein-Westfalen
city: Stolberg
country: Germany
facility: Frauenarztpraxis Dr. Wolfgang Clemens
state: Nordrhein-Westfalen
city: Bernburg
country: Germany
facility: Praxis f. Gynäkologie und Geburtshilfe
state: Sachsen-Anhalt
city: Blankenburg
country: Germany
facility: Frauenarztpraxis Dr. Wetzel
state: Sachsen-Anhalt
city: Berlin
country: Germany
facility: Praxis Hr. Prof. Dr. A. Ebert
city: Berlin
country: Germany
facility: Charité Campus Benjamin Franklin (CBF)
city: Budapest
country: Hungary
facility: Semmelweis University
city: Budapest
country: Hungary
facility: Semmelweis University
city: Budapest
country: Hungary
facility: Bajcsy Zsilinszky Korhaz-Rendelointezet
city: Budapest
country: Hungary
facility: Robert Karoly Magankorhaz
city: Debrecen
country: Hungary
facility: NAP - Rendelo, Private Clinic
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont
city: Szeged
country: Hungary
facility: SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont
city: Szekesfehervar
country: Hungary
facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
city: Avellino
country: Italy
facility: Casa di Cura Privata Malzoni - Villa dei Platani
state: Campania
city: Bologna
country: Italy
facility: A.O.U. di Bologna Policlinico S.Orsola Malpighi
state: Emilia-Romagna
city: Udine
country: Italy
facility: A.S.U. Integrata di Udine
state: Friuli-Venezia Giulia
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli
state: Lazio
city: Genova
country: Italy
facility: IRCCS A.O.U. San Martino IST Ist. Nazionale Ricerca Cancro
state: Liguria
city: Firenze
country: Italy
facility: A.O.U. Careggi
state: Toscana
city: Siena
country: Italy
facility: A.O.U. Senese
state: Toscana
city: Verona
country: Italy
facility: A.O.U. Integrata Verona
state: Veneto
city: Almere
country: Netherlands
facility: Flevoziekenhuis
city: Zwolle
country: Netherlands
facility: Isala
city: Katowice
country: Poland
facility: CLINICAL MEDICAL RESEARCH Sp. z o. o.
city: Katowice
country: Poland
facility: Vita Longa Sp. z o.o.
city: Lodz
country: Poland
facility: Prywatny Gabinet Lekarski Ginekologia, Poloznictwo i Ultr.
city: Lublin
country: Poland
facility: Specjalistyczny Gabinet Ginekologiczno-Polozniczy
city: Lublin
country: Poland
facility: NZOZ NOVITA, Specjalistyczne Gabinety Lekarskie
city: Szczecin
country: Poland
facility: VitroLive Sp. z o.o.
city: Szczecin
country: Poland
facility: Twoja Przychodnia - Szczecinskie Centrum Medyczne
city: Warszawa
country: Poland
facility: NZOZ Zieniewicz Medical
city: Barcelona
country: Spain
facility: Hospital Clínic i Provincial de Barcelona
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario "La Paz"
city: Málaga
country: Spain
facility: Hospital Regional de Málaga
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia
city: York
country: United Kingdom
facility: York Teaching Hospital NHS Foundation Trust
state: North Yorkshire
city: Liverpool
country: United Kingdom
facility: Liverpool Womens Hospital
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich Hospital
city: Prescot
country: United Kingdom
facility: Whiston Hospital
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: