Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bayer
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
Premenopausal women18 years and above at the time of screening.
Women with endometriosis confirmed by laparoscopy or laparotomy within the last ten years but not less than 8 weeks before the screening visit In Japan, diagnosis based on imaging (transvaginal ultrasound or MRI) also qualifies for inclusion.
Moderate to severe endometriosis-associated pelvic pain (EAPP) of ≥5 in the last 28 days before screening visit 1 measured on the numeric rating scale (NRS; i.e. 4-week recall period).
At randomization: Adherence to the study procedures during the screening period, at least 24 diary entries of ESD item 1 during the last 28 consecutive days before the randomization visit, and a sum of the available ESD item 1 ('worst pain' on the daily NRS) entries during this period of at least 98 (corresponding to an average score of ≥ 3.5).
Willingness to use only ibuprofen as rescue pain medication for EAPP, if needed according to investigator's instruction.
Use of a non-hormonal barrier method (i.e. spermicide-coated condoms) for contraception from screening visit until the end of the study. This is not required if adequate contraception is achieved by vasectomy of the partner
You may not be if
Pregnancy or lactation (less than three months since delivery, abortion, or lactation before start of treatment)
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
Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results.
Any disease or condition that may worsen under hormonal treatment according to the assessment and opinion of the investigator.
Undiagnosed abnormal genital bleeding
Wish for pregnancy during the study
Regular use of pain medication due to other underlying diseases
Non-responsiveness of endometriosis associated pelvic pain (EAPP) to GnRH-a or surgery (partial response is not exclusionary).
Clareo Health | Bay98-7196, Dose Finding / POC Study
