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PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata — PEARLIV  

Uterine Fibroids Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01629563
Study type Interventional
Source PregLem SA
Contact
Status Completed
Phase Phase 3
Start date June 2012
Completion date January 2015
View Details
See also
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