Bay98-7196, Dose Finding / POC Study

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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).