Secondary endpoints for the PETAL study were evaluated to assess the
improvement of endometriosis symptoms following treatment with elagolix.
Improvement in endometriosis symptoms was documented using several
different scales for endometriosis pain. The following were assessed
before, during and after the six months of treatment:
-- Total Composite Pelvic Sign and Symptoms Score (CPSSS), a validated
0-15 scale that assesses five components of endometriosis pain
severity, each on a 0-3 scale.
-- Dysmenorrhea (pelvic pain during menstruation), a component of the
CPSSS; 0-3 scale (0=absence of pain, 1=mild pain, 2=moderate pain,
-- 98% of patients at baseline had moderate or severe dysmenorrhea.
-- Non-menstrual pelvic pain (pelvic pain outside of menstruation), a
component of the CPSSS; 0-3 scale (0=absence of pain, 1=mild pain,
2=moderate pain, 3=severe pain)
-- 97% of patients at baseline had moderate or severe non-menstrual
-- Responder Rate, percentage of patients who had a one point or greater
decrease in pain score.
-- Visual Analog Scale (VAS) to assess pelvic pain levels using daily
Elagolix provided a clinically meaningful and statistically significant
reduction in endometriosis pain from baseline as shown below. The magnitude
of improvement is comparable to that demonstrated with the currently
approved agents, leuprolide and DMPA.
Baseline 150mg qd 75mg bid DMPA
Week 4 mean -3.9
|SOURCE Neurocrine Biosciences, Inc.|
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