Pre-menopausal women 18 years and older with confirmed endometriosis and moderate to severe endometriosis-associated pelvic pain (EAPP), otherwise in good general health. MedDRA version: 20.0 Level: PT Classification code 10014778 Term: Endometriosis System Organ Class: 10038604 - Reproductive system and breast disorders
Conditions
Sponsors
Bayer AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed and dated informed consent 2. Pre-menopausal women 18 years (inclusive) and above at the time of Visit 1 3. Women with endometriosis confirmed by laparoscopy or laparotomy OR diagnosed based on imaging 4. Moderate to severe endometriosis-associated pelvic pain (EAPP) 5. Adherence to screening period diary entries 6. Willingness to use only standardized pain medication if needed 7. Good general health (except for findings related to endometriosis) 8. Normal or clinically insignificant cervical cytology not requiring further follow-up 9. An endometrial biopsy performed at the screening phase without significant histological disorder 10. Use of an acceptable non-hormonal method of contraception 11. Willingness / ability to comply with electronic diary entry for the duration of study participation 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 315 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Pregnancy or lactation (less than 3 months since delivery, abortion, or lactation before Visit 1) 2. Hypersensitivity to any ingredient of the study treatments 3. Laboratory values outside the inclusion range before randomization, and considered clinically relevant 4. Any diseases or conditions that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study drug including abnormal liver parameters 5. Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results 6. Undiagnosed abnormal genital bleeding 7. Abuse of alcohol, drugs, or medicines (e.g. laxatives) as evaluated by the investigator 8. Use of other treatments that might interfere with the conduct of the study or the interpretation of the results 9. Endometriosis-specific treatments for symptom relief except rescue pain medication according to protocol 10. Simultaneous participation in another clinical trial with investigational medicinal product(s). Participation in another trial prior to study entry that might have an impact on the study objectives, at the discretion of the investigator 11. Inability to cooperate with the study procedures for any reason 12. Previous assignment to treatment (e.g. randomization) during this study (allowing previously randomized subjects to be re-included into the study may lead to bias) 13. Hypersensitivity to any ingredient of standardized pain medication 14. Wish for pregnancy during the study 15. Regular use of pain medication due to other underlying diseases 16. Non-responsiveness of EAPP to GnRH-a
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to assess the efficacy and safety of two doses of vilaprisan compared to placebo in women with symptomatic endometriosis;Secondary Objective: The secondary objective of this study is to evaluate the safety and tolerability of two different doses of vilaprisan in women with symptomatic endometriosis;Primary end point(s): Change in the subject’s 7-day mean ‘worst pain’ from baseline to Month 3 of the first 24-week treatment period measured on a daily NRS. ;Timepoint(s) of evaluation of this end point: Month 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The proportion of subjects with an improvement on dysmenorrhea AND the proportion of subjects with an improvement on non-menstrual pelvic pain, from baseline and no increase in rescue pain medication use. ;Timepoint(s) of evaluation of this end point: Month 3 | — |
Countries
Austria, Bulgaria, Canada, China, Czech Republic, Denmark, Finland, Germany, Hungary, Italy, Japan, Poland, Portugal, Spain, Sweden, Switzerland, Taiwan, United States
Contacts
Public ContactBayer Clinical Trial Contact
Bayer AG
Outcome results
None listed