Neurocrine Completes Treatment Phase for Endometriosis Study
Neurocrine Biosciences has completed the six-month treatment phase for the elagolix 0603 Phase IIb trial.
The last subject completed her week 24 study visit in early June 2008. This Phase IIb trial (petal study) assesses the impact of elagolix treatment on bone mineral density as the primary endpoint using Dual Energy X-ray Absorptiometry (DXA) scans to document any change from baseline. In addition, efficacy assessments of endometriosis symptoms using the composite pelvic sign and symptoms score and visual analog scale are secondary endpoints.
According to the company, the petal study will contribute to the extensive data set of 10 Phase I studies, two Phase IIa studies and three Phase IIb studies that will serve as the basis for end-of-phase II discussions anticipated in 2009 with the division of reproductive and urologic drug products at the FDA.
Christopher O’Brien, chief medical officer of Neurocrine Biosciences, said: “A total of 252 women with endometriosis were randomized to one of three treatment arms: oral elagolix 150mg once daily, oral elagolix 75mg twice daily or Depo-Provera injection every three months. After completing the six-month treatment phase, subjects continue in the blinded trial for additional DXA, safety and clinical evaluations at six and 12 months post treatment per FDA recommendations.”