Status:
TERMINATED
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
Lead Sponsor:
Bayer
Conditions:
Endometriosis
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 30 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 22 2018
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT03373422
Start Date
November 30 2017
End Date
October 22 2018
Last Update
October 3 2019
Active Locations (68)
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1
Medizinische Universität Graz
Graz, Styria, Austria, 8036
2
Kepler Universitätsklinikum
Linz, Upper Austria, Austria, 4020
3
Landeskrankenhaus - Universitätskliniken Innsbruck
Innsbruck, Austria, 6020
4
Allgemeines Krankenhaus der Stadt Wien
Vienna, Austria, 1090