Study BAY1128688/17472 (AKRENDO 1) was terminated early on 20 July 2018 due to hepatotoxicity

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.

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