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.
Phase of Trial: Phase III
Latest Information Update: 25 Jan 2016
At a glance
- Drugs Ulipristal (Primary) ; Norethisterone
- Indications Uterine haemorrhage; Uterine leiomyoma
- Focus Adverse reactions; Registrational; Therapeutic Use
- Acronyms PEARL-III
- Sponsors PregLem
- 09 Jun 2011 Status changed from recruiting to active, no longer recruiting as reported by ClinicalTrials.gov.(Parent trial; NCT01156857).
- 02 Jun 2011 New source identified (European Clinical Trials Database).
- 16 Dec 2010 Planned end date changed from 1 Mar 2012 to 1 Jan 2014 as reported by ClinicalTrials.gov.