NCT01629563

PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata

A Phase III, Multicentre, Randomized, Double-blind Clinical Study, Investigating the Efficacy and Safety of Repeated 12-week Courses of Daily 5mg or 10mg Doses of PGL4001 for the Long-term Management of Symptomatic Uterine Fibroids

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 451 (actual)
• Sponsor: PregLem SA · Industry
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

Phase III, multicentre, randomized, double-blind, parallel group, long-term study investigating the efficacy and safety of the 5mg and 10mg doses of PGL4001 for the treatment of uterine myoma.

Detailed description

The target population is composed of pre-menopausal women with symptomatic uterine myoma(s) characterised by heavy bleeding.The main objective of this study is to assess the sustained efficacy and safety of long term on-off treatment with PGL4001 5 or 10mg doses on uterine bleeding, myoma size, pain and quality of life.

Conditions

• Uterine Fibroids

Interventions

Type	Name	Description
DRUG	PGL4001 5 mg	PGL4001 5 mg daily administration
DRUG	PGL4001 10 mg	PGL4001 10mg daily administration

Timeline

• Start date: 2012-06-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2012-06-27
• Last updated: 2019-09-04
• Results posted: 2019-09-04

Locations

49 sites across 11 countries: Belgium, Czechia, France, Germany, Hungary, Italy, Latvia, Lithuania, Romania, Ukraine, United Kingdom