132
Participants
Start Date
January 31, 2011
Primary Completion Date
August 31, 2013
Study Completion Date
January 31, 2014
PGL4001, placebo, drug free period
PGL4001 10mg once daily (oral tablets) for 3 months followed by a period of 10 days of placebo (oral tablets) during 3 periods each ending with a drug free period until return of menses.
PGL4001, progestin, drug free period
PGL4001 10mg once daily (oral tablets) for 3 months followed by a period of 10 days of progestin Norethisterone acetate 10mg once daily (oral tablets) during 3 periods each ending with a drug free period until return of menses.
Medical University Vienna, department of obstetrics and gynecology, Vienna
Cliniques Universitaires Saint-Luc Gynécologie-Obstétrique, Brussels
CHR de la Citadelle Gynécologie-Obstétrique, Liège
Cliniques Universitaires UCL de Mont-Godinne Gynécologie-Obstétrique, Yvoir
Clinica Ginecologica CEOGA, departamento de Ginecologia, Lugo
Private Practice, Madrid
HOSPITAL Universitario 12 de Octubre y Fundación de Investigación Biomédica Hospital 12 de Octubre Departamento de Ginecología, Madrid
CHIP (Complejo Hospitalario Integral Privado), Málaga
Prywatna Klinika Polozniczo-Ginekologiczna, Bialystok
INVICTA Sp. Z o.o., Gdansk
Private practice, Katowice
Private practice, Lodz
Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie Klinika Ginekologii Onkologicznej i Ginekologii, Lublin
Private Practice, Warsaw
Private practice, Warsaw
Centralny Szpital Kliniczny MSWiA w Warszawie, Klinika Poloznictwa, Chorob Kobiecych i Ginekologii Onkologicznej, Warsaw
Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wrocławiu, I Katedra i Klinika Ginekologii i Położnictwa, Wroclaw
Hospital Universitario Hebron, gynecology department, Barcelona
Lead Sponsor
PregLem SA
INDUSTRY