Summary:
Premenopausal female subjects (aged 18 to 49 years, inclusive) with a surgical
diagnosis of endometriosis within 10 years prior to screening and with moderate to severe endometriosisassociated
pain.
Criteria:
- Subject is a premenopausal female 18 to 49 years of age (inclusive) at the time of Screening.
- Subject has a surgical diagnosis of endometriosis established by means of documented surgical
visualization (e.g., laparoscopy or laparotomy) within 10 years prior to entry into Washout or
Screening.
- Subject must agree to switch from her usual analgesic medication for endometriosis pain to only
those rescue analgesics permitted by the protocol during the Screening and Treatment Periods.
- Subject must have the following documented in the e-Diary during the last 35 days prior to
Study Day 1:
o At least 2 days of "moderate" or "severe" DYS
AND either
o At least 2 days of "moderate" or "severe" NMPP and an average NMPP score of at least 1.0,
OR
o At least 4 days of "moderate" or "severe" NMPP and an average NMPP score of at least 0.5.