Spots Global Cancer Trial Database for PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata
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Trial Identification
Brief Title: PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata
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 ID: NCT01642472
Conditions
Interventions
Study Description
Brief 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Medical University Vienna, Vienna, , Austria
Cliniques Universitaires Saint-Luc, Gynécologie-Obstétrique,, Brussels, , Belgium
CHR de la Citadelle, Liège, , Belgium
Cliniques Universitaires UCL de Mont-Godinne, Yvoir, , Belgium
Prywatna Klinika Polozniczo-Ginekologiczna, Bialystok, , Poland
INVICTA Sp. Z o.o., Gdańsk, , Poland
Private practice, Katowice, , Poland
Prywatny Gabinet Lekarski Ginekologia I Poloznictwo Ultrasonografia, Lodz, , Poland
Specjalistyczny Gabinet Ginekologiczno-Polozniczy, Lublin, , Poland
Gabinet Lekarski Specjalistyczny "Sonus", Warszawa, , Poland
Centralny Szpital Kliniczny MSWiA w Warszawie, Klinika Poloznictwa, Chorob Kobiecych i Ginekologii Onkologicznej, Warszawa, , Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wrocławiu, I Katedra i Klinika Ginekologii i Położnictwa, Wroclaw, , Poland
Hospital Universitario Vall Hebrón (Gynecology department) Edificio Maternal, Barcelona, , Spain
Clinica Ginecologica CEOGA, Lugo, , Spain
Private Practice, Madrid, , Spain
HOSPITAL Universitario 12 de Octubre y Fundación de Investigación Biomédica Hospital 12 de Octubre, Madrid, , Spain
Contact Details
Name: Elke Bestel, Dr
Affiliation: PregLem SA
Role: STUDY_DIRECTOR
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