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period with elagolix elagolix on bone enrolled
and DMPA active mineral density
comparator plus using DXA scan
additional long-term 2. Dysmenorrhea and
safety assessments pelvic pain
post treatment
0702 Placebo-controlled Dysmenorrhea and 150 Enrolling 1H 09
trial with 2 doses pelvic pain
of optimized assessed with
formulation tablet modified endpoints
0703 Placebo-controlled Dysmenorrhea and 180 Initiated 1H 09
trial with 2 doses pelvic pain
of elagolix and assessed with
leuprolide depot modified endpoints
comparator
The Company completed enrollment in December 2007 of a Phase IIb study in which patients with endometriosis will be treated over a 6-month period. This multi-center, randomized, double-blind, study includes three treatment groups, with two doses of elagolix, 150 mg once a day and 75 mg twice daily, and an active comparator, Depo-Provera(R). In addition to confirming the effect of elagolix on endometriosis symptoms, this study is designed primarily to assess the impact of longer term treatment on bone mineral density as measured by DXA scan at the conclusion of dosing and at 6-months and 12-months post-treatment. Topline results from the 6-month treatment period are expected in the third quarter of 2008. The study will continue after the treatment period for DXA scans and safety assessments. The 6-month results, together with data from the other Phase II studies, will be the basis for securing agreement on a registration plan with the FDA.
The Company is also currently conducting two additional randomized
placebo controlled Phase II clinical trials. The clinical endpoints for
both of these trials are a reduction in pelvic pain associated wit
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| SOURCE Neurocrine Biosciences, Inc. Copyright©2008 PR Newswire. All rights reserved |