NCT01642472

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: PregLem SA · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Uterine Fibroids

Interventions

Type	Name	Description
DRUG	Ulipristal Acetate - open label	Ulipristal Acetate (PGL4001) tablets 10mg orally daily for 3 months (84 days) for each treatment course. There are four 3-month treatment courses in this study.

Timeline

• Start date: 2012-07-01
• Primary completion: 2015-03-01
• Completion: 2015-04-01
• First posted: 2012-07-17
• Last updated: 2016-01-08

Locations

16 sites across 4 countries: Austria, Belgium, Poland, Spain