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

Phase 2

Terminated

• Conditions: Endometriosis
• Interventions: Drug: BAY1128688; Drug: 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

Study Timeline

• Study First Submitted: 2017-11-23
• Study Start: 2017-11-30
• Study First Submitted QC: 2017-12-13
• Study First Posted: 2017-12-14
• Primary Completion: 2018-07-23
• Study Completion: 2018-10-22
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-02
• Last Update Posted: 2019-10-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 121

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

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 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
BAY1128688 (dose 4)	BAY1128688	One BAY1128688 tablet (second intermediate dose) in the morning and one 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

CU Saint-Luc/UZ St-Luc; 🇧🇪 Bruxelles - Brussel, Belgium

Ziekenhuis Oost-Limburg; 🇧🇪 Genk, Belgium

CHU de Tivoli; 🇧🇪 La Louviere, Belgium

Gynekologie MEDA s.r.o.; 🇨🇿 Brno, Czechia

GYN-F s.r.o.; 🇨🇿 Hradec Kralove, Czechia

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