PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata

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.

Inclusion Criteria:

• Subject completed visit F - Follow-up of Pearl III extension study (PGL09-027) - without significant deviations.
• Females of childbearing potential are advised to practice a non-hormonal method of contraception.

Exclusion Criteria:

• Subject has a history of uterus surgery (e.g. hysterectomy, myomectomy) or uterine artery embolization in Pearl III extension (PGL09-027) or afterwards that would interfere with the study assessments.
• Subject has taken or is likely to require treatment during the study with drugs that are not permitted by the study protocol.
• Subject is lactating, has a positive pregnancy test at study start or is planning a pregnancy during the course of the study.
• Subject has abnormal baseline findings, any other medical condition(s) or laboratory finding that, in the opinion of the investigator, might jeopardise the subject's safety or interfere with study evaluations.