PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata
Information source: PregLem SA
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Uterine Fibroids
Intervention: Ulipristal acetate - open label (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: PregLem SA
Summary
This is a phase III, multicentre, long-term open-label extension of the phase III study:
Pearl IIIextension (PGL09-027). During Pearl III (PGL09-026) and subsequent Pearl III
extension (PGL09-027), patients have been exposed to a total of 4 cycles of daily 3month
open-label treatment with ulipristal acetate 10mg before entering the proposed study Pearl
extension 2 (PGL11-024).
This proposed study consists of 4 further consecutive courses of 3 months (84 days) open
label ulipristal acetate 10mg once daily treatment each separated by a drug free period.
Clinical Details
Official title: A Phase III, Multicentre, Extension Study Investigating the Efficacy and Safety of Repeated Intermittent 3-month Courses of Open-label Administration of Ulipristal Acetate, in Subjects With Symptomatic Uterine Myomas and Heavy Uterine Bleeding
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Myoma symptom control assessed with a Global Study Treatment Satisfaction Questionnaire
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Subject completed visit F - Follow-up of Pearl III extension study (PGL09-027) -
without significant deviations.
- Females of childbearing potential are advised to practice a non-hormonal method of
contraception.
Exclusion Criteria:
- Subject has a history of uterus surgery (e. g. hysterectomy, myomectomy) or uterine
artery embolization in Pearl III extension (PGL09-027) or afterwards that would
interfere with the study assessments.
- Subject has taken or is likely to require treatment during the study with drugs that
are not permitted by the study protocol.
- Subject is lactating, has a positive pregnancy test at study start or is planning a
pregnancy during the course of the study.
- Subject has abnormal baseline findings, any other medical condition(s) or laboratory
finding that, in the opinion of the investigator, might jeopardise the subject's
safety or interfere with study evaluations.
Locations and Contacts
Medical University Vienna, Vienna 1090, Austria
Cliniques Universitaires Saint-Luc, Gynécologie-Obstétrique,, Brussels 1200, Belgium
CHR de la Citadelle, Liège 4000, Belgium
Cliniques Universitaires UCL de Mont-Godinne, Yvoir 5530, Belgium
Prywatna Klinika Polozniczo-Ginekologiczna, Bialystok 15-224, Poland
INVICTA Sp. Z o.o., Gdańsk 80-895, Poland
Private practice, Katowice 40-724, Poland
Prywatny Gabinet Lekarski Ginekologia I Poloznictwo Ultrasonografia, Lodz 90-602, Poland
Specjalistyczny Gabinet Ginekologiczno-Polozniczy, Lublin 20-064, Poland
Centralny Szpital Kliniczny MSWiA w Warszawie, Klinika Poloznictwa, Chorob Kobiecych i Ginekologii Onkologicznej, Warszawa 02-507, Poland
Gabinet Lekarski Specjalistyczny "Sonus", Warszawa 02-066, Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wrocławiu, I Katedra i Klinika Ginekologii i Położnictwa, Wroclaw 50-369, Poland
Hospital Universitario Vall Hebrón (Gynecology department) Edificio Maternal, Barcelona 08035, Spain
Clinica Ginecologica CEOGA, Lugo 27002, Spain
HOSPITAL Universitario 12 de Octubre y Fundación de Investigación Biomédica Hospital 12 de Octubre, Madrid 28041, Spain
Private Practice, Madrid 28009, Spain
Additional Information
Starting date: July 2012
Last updated: March 18, 2013
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