PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata
Status:
Completed
Trial end date:
2015-04-01
Target enrollment:
Participant gender:
Summary
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.