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PEARL I trial meets primary efficacy and safety endpoints
04-Jun-2010 - PregLem announced positive Phase III data from its second pivotal study (PEARL I) for its lead product Esmya (ulipristal acetate), as an effective treatment for uterine fibroids (myoma). The final set of positive Phase III results, combined with the positive PEARL II results announced in May ...
PEARL II study meets both primary efficacy and safety endpoints
19-May-2010 - PregLem announced positive Phase III results of EsmyaTM(ulipristal acetate) for the treatment of symptomatic uterine fibroids (myoma). The PEARL II study assessed the efficacy and safety of EsmyaTMcompared to the only currently approved treatment, a GnRH (gonadotropin-releasing hormone) ...
20-Aug-2008 - PregLem SA announced the start of an international Phase III clinical trial program for PGL4001 (ulipristal) in symptomatic uterine myoma, a common benign solid tumor of the genital tract in women of reproductive age. PGL4001, an orally active, selective progesterone receptor modulator, was shown ...
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