Uterine Fibroids Clinical Trial
Official title:
A Phase III, Multicentre, Extension Study Investigating the Efficacy and Safety of Repeated Intermittent 3-month Courses of Open-label Administration of Ulipristal Acetate, in Subjects With Symptomatic Uterine Myomas and Heavy Uterine Bleeding
This is a phase III, multicentre, long-term open-label extension of the phase III study:
Pearl IIIextension (PGL09-027). During Pearl III (PGL09-026) and subsequent Pearl III
extension (PGL09-027), patients have been exposed to a total of 4 cycles of daily 3month
open-label treatment with ulipristal acetate 10mg before entering the proposed study Pearl
extension 2 (PGL11-024).
This proposed study consists of 4 further consecutive courses of 3 months (84 days) open
label ulipristal acetate 10mg once daily treatment each separated by a drug free period.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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