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Neurocrine Announces Full Year Results from 603 Study (Petal Study) of Elagolix for Treatment of Endometriosis Pain
Date:5/18/2009

es across all domains "sometimes," "often" or "always." After treatment this shifted dramatically such that 60-80% of subjects said "never" or "rarely" to these same EHP-5 questions. Equally notable is the observation that much of this improvement was sustained post-treatment.

Estradiol and Ovulation: The previously reported pharmacodynamic effect of elagolix was confirmed. Median estradiol values were maintained in the low baseline range while on treatment and, most importantly, were not lowered to values that would be associated with hot flashes or clinically significant bone loss. As reported, Week 24 median estradiol was 47 pg/ml for elagolix once daily and 29 pg/ml for elagolix twice daily. At Week 48, the median values for the groups were normal at 80 pg/ml and 84 pg/ml, respectively. The mean time to ovulation post-treatment was 24 days for women who had been randomized to elagolix and >90% of subjects had evidence of ovulation within 4 weeks of stopping. Prolonged suppression of ovulation was documented, even out to Week 48 in the DMPA subjects who also reported frequent spotting and irregular vaginal bleeding.

Safety and Tolerability: Assessment of vital signs, physical examination, electrocardiogram, and clinical laboratory tests did not reveal any safety concerns. Adverse events that were reported were generally mild and transient in nature and not usually associated with study discontinuation. The most common adverse events in this trial were consistent with what we have observed in the other elagolix trials including headache (approximately 20% of subjects reported 1 or more headaches during the 6 months of treatment) and nausea (approximately 15% of subjects reported 1 or more episode of nausea). The most common reason for premature discontinuation from the study was withdrawal of consent (i.e., subject moved, work conflict, etc). Seven subjects withdrew from the study with excessive, prolonged or bre
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