PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata (PEARLIII-extension Study)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
PregLem SA
ClinicalTrials.gov Identifier:
NCT01252069
First received: November 30, 2010
Last updated: January 12, 2016
Last verified: January 2016
  Purpose

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.


Condition Intervention Phase
Uterine Fibroids
Drug: PGL4001, placebo, drug free period
Drug: PGL4001, progestin, drug free period
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Further study details as provided by PregLem SA:

Primary Outcome Measures:
  • percentage of subjects in amennorrhoea at the end of each PGL4001 treatment course received [ Time Frame: From baseline to end of each PGL4001 treatment (3months treatment) ] [ Designated as safety issue: No ]

Enrollment: 132
Study Start Date: January 2011
Study Completion Date: January 2014
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
PGL4001 10mg (oral tablets) for 3 months followed by a period of 10 days of placebo (oral tablets) during 3 periods each ended by a drug free period until return of menses.
Drug: 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.
Other Name: Ulipristal acetate
Experimental: B
PGL4001 10mg (oral tablets) for 3 months followed by a period of 10 days of progestin (oral tablets) during 3 periods each ended by a drug free period until return of menses.
Drug: 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.
Other Name: Ulipristal acetate

  Eligibility

Ages Eligible for Study:   18 Years to 48 Years   (Adult)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject completed visit 6 of PGL09-026 study, 10 to 18 days after menstruation following end of treatment with PGL4001, and did not take medications forbidden by the protocol.

Exclusion Criteria:

  • Subject has a large uterine polyp (> 2cm).
  • Subject has one or more ovarian cysts ≥ 4cm diagnosed by ultrasound during PGL09-026 study.
  • Subject has abnormal hepatic function at re-test.
  • Subject has clinically significant abnormal findings at visit A or any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardize the subject's safety or interfere with study evaluations.
  • Subject has a positive pregnancy test or is planning a pregnancy during the course of the study.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01252069

Locations
Austria
Medical University Vienna, department of obstetrics and gynecology
Vienna, Austria, 1090
Belgium
Cliniques Universitaires Saint-Luc Gynécologie-Obstétrique
Bruxelles, Belgium, 1200
CHR de la Citadelle Gynécologie-Obstétrique
Liège, Belgium, 4000
Cliniques Universitaires UCL de Mont-Godinne Gynécologie-Obstétrique
Yvoir, Belgium, 5530
Poland
Prywatna Klinika Polozniczo-Ginekologiczna
Bialystok, Poland, 15-224
INVICTA Sp. Z o.o.
Gdańsk, Poland, 80-895
Private practice
Katowice, Poland, 40-724
Private practice
Lodz, Poland, 90-602
Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie Klinika Ginekologii Onkologicznej i Ginekologii
Lublin, Poland, 20-081
Private Practice
Warszawa, Poland, 00-815
Private practice
Warszawa, Poland, 02-066
Centralny Szpital Kliniczny MSWiA w Warszawie, Klinika Poloznictwa, Chorob Kobiecych i Ginekologii Onkologicznej
Warszawa, Poland, 02-507
Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wrocławiu, I Katedra i Klinika Ginekologii i Położnictwa
Wroclaw, Poland, 50-369
Spain
Hospital Universitario Hebron, gynecology department
Barcelona, Spain, 08035
Clinica Ginecologica CEOGA, departamento de Ginecologia
Lugo, Spain, 27002
Private Practice
Madrid, Spain, 28009
HOSPITAL Universitario 12 de Octubre y Fundación de Investigación Biomédica Hospital 12 de Octubre Departamento de Ginecología
Madrid, Spain, 28041
CHIP (Complejo Hospitalario Integral Privado)
Malaga, Spain, 29010
Sponsors and Collaborators
PregLem SA
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: PregLem SA
ClinicalTrials.gov Identifier: NCT01252069     History of Changes
Other Study ID Numbers: PGL09-027 
Study First Received: November 30, 2010
Last Updated: January 12, 2016
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Poland: Ministry of Health
Austria: Federal Office for Safety in Health Care
Spain: Agencia Española de Medicamentos y Productos Sanitarios

Additional relevant MeSH terms:
Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 30, 2016