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

• Status: Terminated
• Trial end date: 2018-10-22
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer

Criteria

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