Spots Global Cancer Trial Database for PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata (PEARLIII-extension Study)
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Trial Identification
Brief Title: PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata (PEARLIII-extension Study)
Official Title: A Phase III, Multicentre, Clinical Study Investigating the Efficacy and Safety of Three Successive Periods of 3-month Open-label PGL4001 Treatment, Each Followed by Ten Days of Double-blind Treatment With Progestin or Placebo and a Drug-free Period Until Return of Menses, in Subjects With Myomas and Heavy Uterine Bleeding
Study ID: NCT01252069
Conditions
Study Description
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 progestin or placebo tablets after end of PGL4001 treatment. This extension study consists of three periods of 3 months open-label PGL4001 treatment, each followed by ten days of double-blind treatment with progestin or placebo and then a period without treatment.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Medical University Vienna, department of obstetrics and gynecology, Vienna, , Austria
Cliniques Universitaires Saint-Luc Gynécologie-Obstétrique, Bruxelles, , Belgium
CHR de la Citadelle Gynécologie-Obstétrique, Liège, , Belgium
Cliniques Universitaires UCL de Mont-Godinne Gynécologie-Obstétrique, 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
Hospital Universitario Hebron, gynecology department, Barcelona, , Spain
Clinica Ginecologica CEOGA, departamento de Ginecologia, Lugo, , Spain
Private Practice, Madrid, , Spain
HOSPITAL Universitario 12 de Octubre y Fundación de Investigación Biomédica Hospital 12 de Octubre Departamento de Ginecología, Madrid, , Spain
CHIP (Complejo Hospitalario Integral Privado), Malaga, , Spain
Contact Details
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