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

Endometriosis Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03373422
• Other study ID #: 17472
• Secondary ID: 2017-000244-18
• Status: Terminated
• Phase: Phase 2
• Start date: November 30, 2017
• Est. completion date: October 22, 2018

Study information

• Verified date: October 2019
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 121
• Est. completion date: October 22, 2018
• Est. primary completion date: July 23, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endometriosis

Intervention

Drug:
• BAY1128688
Various dosing OD (once daily) and BID (twice daily)
• Placebo
Matching placebo tablets

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Austria,  Belgium,  Czechia,  Denmark,  Finland,  France,  Germany,  Hungary,  Italy,  Netherlands,  Poland,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	12 weeks
Secondary	Incidence of treatment-emergent adverse events		18 weeks