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: 10038604 - Reproductive system and breast disorders; 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-AT
• Lead Sponsor: Bayer AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-08
• Last Update Posted: 12 November 2018

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 (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

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified