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.

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 BAY 1128688 in women with symptomatic endometriosis over a 12-week treatment period - Akrendo 1

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-000244-18-DE

Enrollment

120

Registered

2017-08-14

Start date

2018-02-14

Completion date

Unknown

Last updated

2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometriosis MedDRA version: 20.0 Level: LLT Classification code 10014788 Term: Endometriosis related pain System Organ Class: 10038604 - Reproductive system and breast disorders MedDRA version: 20.0 Level: PT Classification code 10014778 Term: Endometriosis System Organ Class: 10038604 - Reproductive system and breast disorders

Interventions

Product Name: BAY 1128688 coated tablet 3 mg Product Code: BAY 1128688 coated tablet 3 mg 001 Pharmaceutical Form: Coated tablet INN or Proposed INN: no

Eligibility

Sex/Gender

All

Inclusion criteria

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 (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. 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

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
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	—

Countries

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

Contacts

Public ContactClinical Trials Contact

Bayer AG

clinical-trials-contact@bayer.com+4930300139003

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026