Status:
COMPLETED
PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata (PEARLIII-extension Study)
Lead Sponsor:
PregLem SA
Conditions:
Uterine Fibroids
Eligibility:
FEMALE
18-48 years
Phase:
PHASE3
Brief 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 progest...
Eligibility Criteria
Inclusion
- Subject completed visit 6 of PGL09-026 study, 10 to 18 days after menstruation following end of treatment with PGL4001, and did not take medications forbidden by the protocol.
Exclusion
- Subject has a large uterine polyp (\> 2cm).
- Subject has one or more ovarian cysts ≥ 4cm diagnosed by ultrasound during PGL09-026 study.
- Subject has abnormal hepatic function at re-test.
- Subject has clinically significant abnormal findings at visit A or any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardize the subject's safety or interfere with study evaluations.
- Subject has a positive pregnancy test or is planning a pregnancy during the course of the study.
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT01252069
Start Date
January 1 2011
End Date
January 1 2014
Last Update
January 13 2016
Active Locations (18)
Enter a location and click search to find clinical trials sorted by distance.
1
Medical University Vienna, department of obstetrics and gynecology
Vienna, Austria, 1090
2
Cliniques Universitaires Saint-Luc Gynécologie-Obstétrique
Brussels, Belgium, 1200
3
CHR de la Citadelle Gynécologie-Obstétrique
Liège, Belgium, 4000
4
Cliniques Universitaires UCL de Mont-Godinne Gynécologie-Obstétrique
Yvoir, Belgium, 5530