NCT00755755

PGL4001 Versus Placebo in Uterine Myomas

A Phase III, Randomized, Parallel Group, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of PGL4001 (Ulipristal) Versus Placebo for Pre-Operative Treatment of Symptomatic Uterine Myomas

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 241 (actual)
• Sponsor: PregLem SA · Industry
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

This trial will assess the efficacy and safety of PGL4001 with concomitant iron administration versus placebo with concomitant iron administration, over a 3-month period for the pre-operative treatment of pre-menopausal women suffering from excessive uterine bleeding due to uterine myoma.

Conditions

• Uterine Myomas

Interventions

Type	Name	Description
DRUG	PGL4001 (ulipristal) and iron	tablets
DRUG	PGL4001 matching placebo and iron	tablets
DRUG	PGL4001 (ulipristal) and iron	Tablets

Timeline

• Start date: 2008-10-01
• Primary completion: 2010-03-01
• Completion: 2010-08-01
• First posted: 2008-09-19
• Last updated: 2012-12-13
• Results posted: 2012-11-16

Locations

38 sites across 6 countries: Czechia, Hungary, India, Romania, Russia, Ukraine