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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
PregLem SA
ClinicalTrials.gov Identifier:
NCT01156857
First received: July 1, 2010
Last updated: June 6, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Uterine Fibroids
Drug: PGL4001, placebo
Drug: PGL4001, progestin
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 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.

Resource links provided by NLM:


Further study details as provided by PregLem SA:

Primary Outcome Measures:
  • Efficacy endpoints [ Time Frame: From baseline to end of PGL4001 treatment (3months treatment) and to approximately 2 weeks after double blind treatment with progestin/placebo. ] [ Designated as safety issue: No ]
    Investigate efficacy of PGL4001 on uterine bleeding (% of subjects in amenorrhea at end of PGL4001 treatment), myoma size (transvaginal ultrasound), pain (short Mc Gill questionnaire) and quality of life (specific UFS-QoL questionnaire and general EQ-5D questionnaire).

  • Safety endpoints [ Time Frame: From baseline to end of PGL4001 treatment (3months treatment) and to approximately 2 weeks after double blind treatment with progestin/placebo ] [ Designated as safety issue: Yes ]
    Number and proportion of subjects experiencing treatment-emergent adverse events observed by physical examination, transvaginal ultrasound and blood samples.

  • Exploratory endpoints [ Time Frame: From baseline to end of PGL4001 treatment (3months treatment) ] [ Designated as safety issue: No ]
    Assessment of the strengh of the first menstraual bleed after PGL4001 treament using the Pictorial Bleeding Assessment Chart (PBAC).


Enrollment: 209
Study Start Date: July 2010
Study Completion Date: February 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Drug: PGL4001 10mg (oral tablets) for 3 months followed by a period of 10 days of placebo (oral tablets).
Drug: PGL4001, placebo
PGL4001 10mg (oral tablets) for 3 months followed by a period of 10 days of placebo (oral tablets).
Other Name: Ulipristal acetate
Experimental: B
Drug: PGL4001 10mg (oral tablets) for 3 months followed by a period of 10 days of progestin (oral tablets).
Drug: PGL4001, progestin
PGL4001 10mg (oral tablets) for 3 months followed by a period of 10 days of progestin (oral tablets).
Other Name: Ulipristal acetate

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.

  Eligibility

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

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 no myoma 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 of contraception.

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 biopsy performed 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 ulipristal acetate.
  • Subject has abnormal hepatic function at study entry.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01156857

Locations
Austria
Medical University Graz, department of obstetrics and gynecology
Graz, Austria, 8047
Medical University Vienna, department of obstetrics and gynecology
Vienna, Austria, 1090
Belgium
Cliniques Universitaires Saint-Luc
Bruxelles, Belgium, 1200
CHR de la citadelle
Liège, Belgium, 4000
Cliniques Universitaires UCL de Mont-Godinne
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, 02-066
Private Practice
Warszawa, Poland, 00-815
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 Clinic i provincial de Barcelona, gynecology department
Barcelona, Spain, 08036
Hospital Universitario Hebron, gynecology department
Barcelona, Spain, 08035
Institut Universitari Dexeus Departamento de Ginecología
Barcelona, Spain, 08028
Hospital General de Ciudad Real Gynecology
Ciudad Real, Spain, 13005
Hospital Universitario de Guadalajara Consultas de Ginecología (Planta 0)
Guadalajara, Spain, 19002
Clinica Ginecologica CEOGA, departamento de Ginecologia
Lugo, Spain, 27002
Hospital universitario 12 de Octubre, departamento de ginecologia
Madrid, Spain, 28041
Private pratice
Madrid, Spain, 28009
CHIP
Malaga, Spain, 29010
Sponsors and Collaborators
PregLem SA
  More Information

No publications provided by PregLem SA

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: PregLem SA
ClinicalTrials.gov Identifier: NCT01156857     History of Changes
Other Study ID Numbers: PGL09-026
Study First Received: July 1, 2010
Last Updated: June 6, 2013
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Poland: Ministry of Health
Spain: Spanish Agency of Medicines
Austria: Federal Office for Safety in Health Care

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

ClinicalTrials.gov processed this record on November 24, 2014