NCT01252069

PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata (PEARLIII-extension Study)

A Phase III, Multicentre, Clinical Study Investigating the Efficacy and Safety of Three Successive Periods of 3-month Open-label PGL4001 Treatment, Each Followed by Ten Days of Double-blind Treatment With Progestin or Placebo and a Drug-free Period Until Return of Menses, in Subjects With Myomas and Heavy Uterine Bleeding

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 132 (actual)
• Sponsor: PregLem SA · Industry
• Sex: Female
• Age: 18 Years – 48 Years
• Healthy volunteers: Not accepted

Summary

This is the long-term extension of a phase III, efficacy and safety open-label (protocol PGL09-026) with PGL4001 10mg tablets once daily for three months, blinded towards the administration of progestin or placebo tablets after end of PGL4001 treatment. This extension study consists of three periods of 3 months open-label PGL4001 treatment, each followed by ten days of double-blind treatment with progestin or placebo and then a period without treatment.

Conditions

• Uterine Fibroids

Interventions

Type	Name	Description
DRUG	PGL4001, placebo, drug free period	PGL4001 10mg once daily (oral tablets) for 3 months followed by a period of 10 days of placebo (oral tablets) during 3 periods each ending with a drug free period until return of menses.
DRUG	PGL4001, progestin, drug free period	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) during 3 periods each ending with a drug free period until return of menses.

Timeline

• Start date: 2011-01-01
• Primary completion: 2013-08-01
• Completion: 2014-01-01
• First posted: 2010-12-02
• Last updated: 2016-01-13

Locations

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