NCT01156857

PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata

A Phase III, Multicentre, Clinical Study Investigating the Efficacy and Safety of 3-months Open-label Treatment With PGL4001, Followed by a Randomised, Double-blind Placebo Controlled Period of 10 Days Treatment With Progestin, in Subjects With Myomas and Heavy Uterine Bleeding.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 209 (actual)
• Sponsor: PregLem SA · Industry
• Sex: Female
• Age: 18 Years – 48 Years
• Healthy volunteers: Not accepted

Summary

This is a multicentre, Phase III, efficacy and safety open-label study with PGL4001 10mg once daily for 3 months, blinded towards the administration of progestin or placebo after end of PGL4001 treatment.

Detailed description

PGL4001 will be administered daily to all subjects in an open-label manner with no control group. The three months open label treatment period will be followed by a ten day double blind treatment with progestin or matching placebo. Subjects will be randomly assigned to progestin or matching placebo arm with a 1:1 ratio.

Conditions

• Uterine Fibroids

Interventions

Type	Name	Description
DRUG	PGL4001, placebo	PGL4001 10mg once daily (oral tablets) for 3 months followed by a period of 10 days of placebo (oral tablets).
DRUG	PGL4001, progestin	PGL4001 10mg once daily (oral tablets) for 3 months followed by a period of 10 days of progestin Norethisterone acetate 10mg once daily (oral tablets).

Timeline

• Start date: 2010-07-01
• Primary completion: 2011-11-01
• Completion: 2012-02-01
• First posted: 2010-07-05
• Last updated: 2016-01-15

Locations

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