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 1

• Conditions: Endometriosis; MedDRA version: 20.0 Level: LLT Classification code 10014788 Term: Endometriosis related pain System Organ Class: 100000024185; MedDRA version: 20.0 Level: PT Classification code 10014778 Term: Endometriosis System Organ Class: 10038604 - Reproductive system and breast disorders; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2017-000244-18-NL
• Lead Sponsor: Bayer AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-09-12
• Study Completion: 2018-10-22
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 121

Inclusion Criteria

- Women of at least 18 years of age at the time of signing of informed consent
- Diagnosis of endometriosis confirmed by at least one of the two criteria:
-- visually-confirmed (by surgery or clinical inspection) within the last 10 years
-- imaging-confirmed within the last 12 months
- Symptoms of moderate to severe pelvic pain which will be assessed over a period of 28 days
- Good general health
- 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 (maximum 280 days) and to refrain from using hormonal contraception

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 120
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Pregnancy or lactation (less 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 and/or contraindications to using the study drug
- Signs of hyperandrogenism
- Absence of menstrual cycles and/or abnormal vaginal/genital bleeding
- History of hysterectomy, tubal-ligation or bilateral ovariectomy
- Any diseases, conditions or medications/treatments that might intefere with the conduct of the study or the interpretation of the results

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Explore the dose response relationship of different doses of BAY 1128688 compared to placebo in the treatment of endometriosis-related symptoms over a 12-week treatment period;Secondary Objective: Assessment of safety and tolerability of BAY 1128688 over a 12-week treatment period ;Primary end point(s): Absolute change in mean pain of the 7 days with worst EAPP from baseline (last 28 days before SoT visit) to end of treatment (last 28 days of the treatment period, Day 57 - 84) (measured on the NRS by item 1 of the ESD).;Timepoint(s) of evaluation of this end point: 12 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The secondary safety variable is the incidence of treatment-emergent adverse events;Timepoint(s) of evaluation of this end point: 18 weeks