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, 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.
Study ID: NCT01156857
Conditions
Study Description
Brief Summary: This is a multicentre, Phase III, efficacy and safety open-label study with PGL4001 10mg once daily for 3 months, blinded towards the administration of progestin or placebo after end of PGL4001 treatment.
Detailed Description: PGL4001 will be administered daily to all subjects in an open-label manner with no control group. The three months open label treatment period will be followed by a ten day double blind treatment with progestin or matching placebo. Subjects will be randomly assigned to progestin or matching placebo arm with a 1:1 ratio.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Medical University Graz, department of obstetrics and gynecology, Graz, , Austria
Medical University Vienna, department of obstetrics and gynecology, Vienna, , Austria
Cliniques Universitaires Saint-Luc, Bruxelles, , 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
Private Practice, Lodz, , Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie Klinika Ginekologii Onkologicznej i Ginekologii, Lublin, , Poland
Private Practice, Warszawa, , Poland
Private Practice, 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
Institut Universitari Dexeus Departamento de Ginecología, Barcelona, , Spain
Hospital Universitario Hebron, gynecology department, Barcelona, , Spain
Hospital Clinic i provincial de Barcelona, gynecology department, Barcelona, , Spain
Hospital General de Ciudad Real Gynecology, Ciudad Real, , Spain
Hospital Universitario de Guadalajara Consultas de Ginecología (Planta 0), Guadalajara, , Spain
Clinica Ginecologica CEOGA, departamento de Ginecologia, Lugo, , Spain
Private pratice, Madrid, , Spain
Hospital universitario 12 de Octubre, departamento de ginecologia, Madrid, , Spain
CHIP, Malaga, , Spain
Contact Details
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