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AKRENDO1: 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

Sponsor
Bayer (Industry)
Overall Status
Terminated
CT.gov ID
NCT03373422
Collaborator
(none)
121
Enrollment
68
Locations
6
Arms
10.7
Actual Duration (Months)
1.8
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
121 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Nov 30, 2017
Actual Primary Completion Date :
Jul 23, 2018
Actual Study Completion Date :
Oct 22, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: BAY1128688 (dose 1)

One BAY1128688 tablet (lowest dose) in the morning, one placebo tablet in the evening

Drug: BAY1128688
Various dosing OD (once daily) and BID (twice daily)

Drug: Placebo
Matching placebo tablets
Experimental: BAY1128688 (dose 2)

One BAY1128688 tablet (first intermediate dose) in the morning, one placebo tablet in the evening

Drug: BAY1128688
Various dosing OD (once daily) and BID (twice daily)

Drug: Placebo
Matching placebo tablets
Experimental: BAY1128688 (dose 3)

One BAY1128688 tablet (second intermediate dose) in the morning, one placebo tablet in the evening

Drug: BAY1128688
Various dosing OD (once daily) and BID (twice daily)

Drug: Placebo
Matching placebo tablets
Experimental: BAY1128688 (dose 4)

One BAY1128688 tablet (second intermediate dose) in the morning and one in the evening

Drug: BAY1128688
Various dosing OD (once daily) and BID (twice daily)
Experimental: BAY1128688 (dose 5)

One BAY1128688 tablet (highest dose) in the morning and one in the evening

Drug: BAY1128688
Various dosing OD (once daily) and BID (twice daily)
Placebo Comparator: Placebo

One placebo tablet in the morning and one in the evening

Drug: Placebo
Matching placebo tablets

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Incidence of treatment-emergent adverse events [18 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kepler Universitätsklinikum Linz Oberösterreich Austria 4020
2 Medizinische Universität Graz Graz Steiermark Austria 8036
3 Landeskrankenhaus - Universitätskliniken Innsbruck Innsbruck Austria 6020
4 Allgemeines Krankenhaus der Stadt Wien Wien Austria 1090
5 AZ Jan Palfijn Gent Gent Oost-Vlaanderen Belgium 9000
6 CU Saint-Luc/UZ St-Luc Bruxelles - Brussel Belgium 1200
7 Ziekenhuis Oost-Limburg Genk Belgium 3600
8 CHU de Tivoli La Louviere Belgium 7100
9 Gynekologie MEDA s.r.o. Brno Czechia 602 00
10 GYN-F s.r.o. Hradec Kralove Czechia 500 03
11 G-Centrum Olomouc s.r.o. Dr. Skrivanek Olomouc Czechia 772 00
12 Centrum gynekologicke rehabilitace Pisek Czechia 39701
13 GynCare MUDr. Michael Svec s.r.o. Plzen Czechia 326 00
14 Dr. Smrhova-Kovacs Tabor Czechia 39003
15 Aarhus Universitetshospital, Skejby Aarhus N Denmark 8200
16 H:S Rigshospitalet København Ø Denmark DK-2100
17 HUS / Naistenklinikka Helsinki Finland 00290
18 Keski-Suomen keskussairaala Jyväskylä Finland 40620
19 Lääkäriasema Cantti Oy Kuopio Finland 70110
20 Lääkärikeskus Gyneko Oulu Finland 90100
21 Centre Hospitalier Universitaire - Angers Angers France 49100
22 Cochin - Paris Paris France 75674
23 Vincentius-Diakonissen-Kliniken gAG Karlsruhe Baden-Württemberg Germany 76199
24 Praxisklinik am Rosengarten Mannheim Baden-Württemberg Germany 68165
25 Klinikum rechts der Isar München Bayern Germany 81675
26 Praxis Hr. Dr. A. Gerick Aachen Nordrhein-Westfalen Germany 52072
27 Praxis Hr. Dr. S. Fiedler Aachen Nordrhein-Westfalen Germany 52074
28 Frauenarztpraxis Dr. Wolfgang Clemens Stolberg Nordrhein-Westfalen Germany 52222
29 Praxis f. Gynäkologie und Geburtshilfe Bernburg Sachsen-Anhalt Germany 06406
30 Frauenarztpraxis Dr. Wetzel Blankenburg Sachsen-Anhalt Germany 38889
31 Praxis Hr. Prof. Dr. A. Ebert Berlin Germany 10787
32 Charité Campus Benjamin Franklin (CBF) Berlin Germany 12200
33 Semmelweis University Budapest Hungary 1082
34 Semmelweis University Budapest Hungary 1085
35 Bajcsy Zsilinszky Korhaz-Rendelointezet Budapest Hungary 1106
36 Robert Karoly Magankorhaz Budapest Hungary 1135
37 NAP - Rendelo, Private Clinic Debrecen Hungary 4028
38 Debreceni Egyetem Klinikai Kozpont Debrecen Hungary 4032
39 SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont Szeged Hungary 6725
40 Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz Szekesfehervar Hungary 8000
41 Casa di Cura Privata Malzoni - Villa dei Platani Avellino Campania Italy 83100
42 A.O.U. di Bologna Policlinico S.Orsola Malpighi Bologna Emilia-Romagna Italy 40138
43 A.S.U. Integrata di Udine Udine Friuli-Venezia Giulia Italy 33100
44 Fondazione Policlinico Universitario Agostino Gemelli Roma Lazio Italy 00168
45 IRCCS A.O.U. San Martino IST Ist. Nazionale Ricerca Cancro Genova Liguria Italy 16132
46 A.O.U. Careggi Firenze Toscana Italy 50134
47 A.O.U. Senese Siena Toscana Italy 53100
48 A.O.U. Integrata Verona Verona Veneto Italy 37126
49 Flevoziekenhuis Almere Netherlands 1315 RA
50 Isala Zwolle Netherlands 8025 AB
51 CLINICAL MEDICAL RESEARCH Sp. z o. o. Katowice Poland 40-001
52 Vita Longa Sp. z o.o. Katowice Poland 40-748
53 Prywatny Gabinet Lekarski Ginekologia, Poloznictwo i Ultr. Lodz Poland 90-602
54 Specjalistyczny Gabinet Ginekologiczno-Polozniczy Lublin Poland 20-064
55 NZOZ NOVITA, Specjalistyczne Gabinety Lekarskie Lublin Poland 20-632
56 VitroLive Sp. z o.o. Szczecin Poland 70-483
57 Twoja Przychodnia - Szczecinskie Centrum Medyczne Szczecin Poland 71-434
58 NZOZ Zieniewicz Medical Warszawa Poland 02-201
59 Hospital Clínic i Provincial de Barcelona Barcelona Spain 08036
60 Hospital Universitario 12 de Octubre Madrid Spain 28041
61 Hospital Universitario "La Paz" Madrid Spain 28046
62 Hospital Regional de Málaga Málaga Spain 29010
63 Hospital Universitario Virgen del Rocío Sevilla Spain 41013
64 Hospital General Universitario de Valencia Valencia Spain 46014
65 York Teaching Hospital NHS Foundation Trust York North Yorkshire United Kingdom YO318HE
66 Liverpool Womens Hospital Liverpool United Kingdom L8 7SS
67 Norfolk and Norwich Hospital Norwich United Kingdom NR4 7UY
68 Whiston Hospital Prescot United Kingdom L35 5DR

Sponsors and Collaborators

  • Bayer

Investigators

  • Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bayer
ClinicalTrials.gov Identifier:
NCT03373422
Other Study ID Numbers:
  • 17472
  • 2017-000244-18
First Posted:
Dec 14, 2017
Last Update Posted:
Oct 3, 2019
Last Verified:
Oct 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Endometriosis

Study Results

No Results Posted as of Oct 3, 2019