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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Endometriosis

Intervention / Treatment
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* Drug: BAY1128688
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BAY1128688 (dose 1)<br>One BAY1128688 tablet (lowest dose) in the morning, one placebo tablet in the evening | Drug: BAY1128688<br>* Various dosing OD (once daily) and BID (twice daily)<br>Drug: Placebo<br>* Matching placebo tablets<br>|
| Experimental: BAY1128688 (dose 2)<br>One BAY1128688 tablet (first intermediate dose) in the morning, one placebo tablet in the evening | Drug: BAY1128688<br>* Various dosing OD (once daily) and BID (twice daily)<br>Drug: Placebo<br>* Matching placebo tablets<br>|
| Experimental: BAY1128688 (dose 3)<br>One BAY1128688 tablet (second intermediate dose) in the morning, one placebo tablet in the evening | Drug: BAY1128688<br>* Various dosing OD (once daily) and BID (twice daily)<br>Drug: Placebo<br>* Matching placebo tablets<br>|
| Experimental: BAY1128688 (dose 4)<br>One BAY1128688 tablet (second intermediate dose) in the morning and one in the evening | Drug: BAY1128688<br>* Various dosing OD (once daily) and BID (twice daily)<br>|
| Experimental: BAY1128688 (dose 5)<br>One BAY1128688 tablet (highest dose) in the morning and one in the evening | Drug: BAY1128688<br>* Various dosing OD (once daily) and BID (twice daily)<br>|
| Placebo Comparator: Placebo<br>One placebo tablet in the morning and one in the evening | Drug: Placebo<br>* Matching placebo tablets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of treatment-emergent adverse events |  | 18 weeks |