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 BAY1128688 in Women With Symptomatic Endometriosis Over a 12-week Treatment Period

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03373422

Acronym

AKRENDO1

Enrollment

121

Registered

2017-12-14

Start date

2017-11-30

Completion date

2018-10-22

Last updated

2019-10-03

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

Conditions

Endometriosis

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.

Interventions

DRUGBAY1128688

Various dosing OD (once daily) and BID (twice daily)

DRUGPlacebo

Matching placebo tablets

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame
Incidence of treatment-emergent adverse events	18 weeks

Countries

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026