PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata

Last updated: January 14, 2016
Sponsor: PregLem SA
Overall Status: Completed

Phase

3

Condition

Uterina Myoma

Desmoid Tumors

Uterine Fibroids

Treatment

N/A

Clinical Study ID

NCT01156857
PGL09-026
  • Ages 18-48
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subject is a pre-menopausal woman aged between 18 and 48 years inclusive.

  • Subject with a Body Mass Index ≥18 and ≤40.

  • Subject with myomatous uterus size < 16 weeks.

  • Subject must have at least one uterine myoma of at least 3 cm diameter in size and nomyoma larger than 10 cm diameter diagnosed by ultrasound.

  • Subject complained of strong uterine bleeding.

  • Subject is eligible for hysterectomy or myomectomy.

  • Females of childbearing potential have to practice a non-hormonal method ofcontraception.

Exclusion

Exclusion Criteria:

  • Subject has a history of or current uterus, cervix, ovarian or breast cancer.

  • Subject has a history of endometrium hyperplasia or adenocarcinoma in a biopsyperformed within the past 6 months or similar lesions in the screening biopsy.

  • Subject has a known severe coagulation disorder.

  • Subject has a history of treatment for myoma with a SPRM, including ulipristalacetate.

  • Subject has abnormal hepatic function at study entry.

Study Design

Total Participants: 209
Study Start date:
July 01, 2010
Estimated Completion Date:
February 29, 2012

Study 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.

Connect with a study center

  • Medical University Graz, department of obstetrics and gynecology

    Graz, 8047
    Austria

    Site Not Available

  • Medical University Vienna, department of obstetrics and gynecology

    Vienna, 1090
    Austria

    Site Not Available

  • Cliniques Universitaires Saint-Luc

    Bruxelles, 1200
    Belgium

    Site Not Available

  • CHR de la citadelle

    Liège, 4000
    Belgium

    Site Not Available

  • CHR de la citadelle

    Liège, 4000
    Belgium

    Site Not Available

  • Cliniques Universitaires UCL de Mont-Godinne

    Yvoir, 5530
    Belgium

    Site Not Available

  • Prywatna Klinika Polozniczo-Ginekologiczna

    Bialystok, 15-224
    Poland

    Site Not Available

  • INVICTA Sp. Z o.o.

    Gdańsk, 80-895
    Poland

    Site Not Available

  • INVICTA Sp. Z o.o.

    Gdańsk, 80-895
    Poland

    Site Not Available

  • Private Practice

    Katowice, 40-724
    Poland

    Site Not Available

  • Private Practice

    Lodz, 90-602
    Poland

    Site Not Available

  • Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie Klinika Ginekologii Onkologicznej i Ginekologii

    Lublin, 20-081
    Poland

    Site Not Available

  • Centralny Szpital Kliniczny MSWiA w Warszawie, Klinika Poloznictwa, Chorob Kobiecych i Ginekologii Onkologicznej

    Warszawa, 02-507
    Poland

    Site Not Available

  • Private Practice

    Warszawa, 02-066
    Poland

    Site Not Available

  • Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wrocławiu, I Katedra i Klinika Ginekologii i Położnictwa

    Wroclaw, 50-369
    Poland

    Site Not Available

  • Hospital Clinic i provincial de Barcelona, gynecology department

    Barcelona, 08036
    Spain

    Site Not Available

  • Hospital Universitario Hebron, gynecology department

    Barcelona, 08035
    Spain

    Site Not Available

  • Institut Universitari Dexeus Departamento de Ginecología

    Barcelona, 08028
    Spain

    Site Not Available

  • Hospital General de Ciudad Real Gynecology

    Ciudad Real, 13005
    Spain

    Site Not Available

  • Hospital Universitario de Guadalajara Consultas de Ginecología (Planta 0)

    Guadalajara, 19002
    Spain

    Site Not Available

  • Clinica Ginecologica CEOGA, departamento de Ginecologia

    Lugo, 27002
    Spain

    Site Not Available

  • Hospital universitario 12 de Octubre, departamento de ginecologia

    Madrid, 28041
    Spain

    Site Not Available

  • Private pratice

    Madrid, 28009
    Spain

    Site Not Available

  • CHIP

    Malaga, 29010
    Spain

    Site Not Available

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