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.

Phase 1

Conditions: Endometriosis
MedDRA version: 20.0Level: LLTClassification code 10014788Term: Endometriosis related painSystem Organ Class: 100000024185
MedDRA version: 20.0Level: PTClassification code 10014778Term: EndometriosisSystem Organ Class: 10038604 - Reproductive system and breast disorders
Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

Registration Number: EUCTR2017-000244-18-ES

Lead Sponsor: Bayer AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 120

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 (maximum 280 days) and to 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

- 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