PGL4001 Versus Placebo in Uterine Myomas (PEARLI)

December 11, 2012 updated by: PregLem SA

A Phase III, Randomized, Parallel Group, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of PGL4001 (Ulipristal) Versus Placebo for Pre-Operative Treatment of Symptomatic Uterine Myomas

This trial will assess the efficacy and safety of PGL4001 with concomitant iron administration versus placebo with concomitant iron administration, over a 3-month period for the pre-operative treatment of pre-menopausal women suffering from excessive uterine bleeding due to uterine myoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

241

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Brno, Czech Republic, 625 00
        • Gynekologicko-porodnicka klinika FN Brno
      • Praha, Czech Republic, 110 00
        • Mediva
      • Praha, Czech Republic, 128 00
        • Gynekologicko-porodnicka klinika 1.LF UK a VFN
      • Praha, Czech Republic, 150 06
        • Gynekologicko-porodnicka klinika UK 2.LF a FN
  • Hungary
      • Bekescsaba, Hungary, 5600
        • Rethy-Pal Hospital-Clinic Bekescsaba, Department of Obstetrics and Gynecology
      • Budapest, Hungary, 1096
        • Saint Stephen Hospital of Budapest,Department of Obstetrics, Gynecology and Gynecological Oncology
      • Budapest, Hungary, 1106
        • Fovarosi Bajcsy-Zsilinszky Hospital, Department of Obstetrics and Gynecology
      • Szekesfehervar, Hungary, 8000
        • Saint George Hospital of Fejer County, Department of Obstetrics and Gynecology
      • Szentes, Hungary, 6600
        • Dr. Bugyi Istvan Hospital, Department of Obstetrics and Gynecology
      • Tatabanya, Hungary, 2800
        • Saint Borbala Hospital of Komarom-Esztergom County, Department of Obstetrics and Gynecology
  • India
      • Aurangabad, India, 431001
        • Dr. Jilla Hospital
      • Bangalore, India, 560054
        • M. S. Ramaiah Medical College and Memorial Hospital
      • Bangalore, India, 560078
        • Divakars Speciality Hospital
      • Chennai, India, 600116
        • Sri Ramachandra Medical College and Research Institute
      • Nagpur, India, 440010
        • Om Women's Hospital
      • Nagpur, India, 440022
        • Nagpur Test Tube Baby Centre
  • Romania
      • Bucharest, Romania, 011026
        • Central Medical Sanador
      • Bucharest, Romania, 020395
        • Departamentul de Obstretica Ginecologie si Nou Nascuti
      • Bucharest, Romania, 70266
        • Sectia Obstretica-Ginecologie Spitalul Clinic Dr. Ioan Cantacuzino
      • Bucuresti, Romania, 020762
        • Centrul Medical Euromed, departementul de Obstetrica/Ginecologie
      • Oradea, Romania, 410053
        • Spitalul Clinic de Obstetrica Ginecologie Oradea
      • Targu Mures, Romania, 540136
        • Spitalul Clinic Judetean de urgenta, sectia de obstetrica Ginecologie I
  • Russian Federation
      • Arkhangelsk, Russian Federation, 163001
        • Northern State Medical University
      • Kursk, Russian Federation, 305035
        • Kursk State Medical University
      • Samara, Russian Federation, 443067
        • OAO "Medical company IDK"
      • St. Petersburg, Russian Federation, 190000
        • American Medical Clinic
      • St.Petersburg, Russian Federation, 193312
        • Saint-Petersburg City Alexandrovsky Hospital
      • St.Petersburg, Russian Federation, 194044
        • Military Medical Academy n.a.S.M Kirov, chair of Obstetrics and Gynecology
      • St.Petersburg, Russian Federation, 196084
        • Medical Research Institute (MRI)
      • St.Petersburg, Russian Federation, 197758
        • Russian Scientific Research Center of Radiology and Surgical Technologies
      • St.Petersburg, Russian Federation, 199034
        • Scientific Research Institute of Obstetrics and Gynecology n.a. D.O.Ott of RAMS
  • Ukraine
      • Donetsk, Ukraine
        • Donetsk National Medical University, Department of Obstetrics, Gynecology and Perinatology FPE
      • Kiev, Ukraine, 04112
        • City Clinical Hospital N9
      • Kiev, Ukraine
        • Institute of Pediatrics, Obstetrics and Gynecology, Department of Endocrine Gynecology
      • Kiev, Ukraine
        • Kiev Maternity Hospital No.2
      • Kyiv, Ukraine
        • State Enterprise "Institute of Pediatrics, Obstetrics and Gynecology of AMS of Ukraine
      • Lviv, Ukraine, 79032
        • Lviv National Medical University named after Danylo Halytskyy
      • Zaporizhzhya, Ukraine
        • Medical Sanitory Centre VAT "Motor Sich" Gynecology department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Be a pre-menopausal woman between 18 and 50 years inclusive.
  • Have excessive uterine bleeding due to myoma.
  • Have a myoma-related anaemia.
  • Have a myomatous uterus with at least one myoma of ≥ 3 cm diameter in size.
  • Be eligible for one surgical procedure: e.g. hysterectomy, myomectomy or others.
  • If of childbearing potential the subject must be practicing a non-hormonal method of contraception.
  • Have a Body Mass Index (BMI) ≥ 18 and ≤ 40.

Exclusion Criteria:

  • Has a history of or current uterine, cervical, ovarian or breast cancer.
  • Has a history of or current endometrium atypical hyperplasia.
  • Has a known severe coagulation disorder.
  • Has a history of or current treatment for myoma with a Selective Progesterone Receptor Modulator (SPRM) or a GnRH-agonist.
  • Has abnormal hepatic function at study entry.
  • Has a positive pregnancy test at baseline or is nursing or planning a pregnancy during the course of the study.
  • Has a current (within twelve months) problem with alcohol or drug abuse.
  • Is currently enrolled in an investigational drug or device study or has participated in such a study within the last 30 days.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A (PGL4001 5mg)
PGL4001 5 mg (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
Drug: PGL4001 (ulipristal) and iron
tablets
Other Names:
  • Ulipristal acetate
Drug: PGL4001 (ulipristal) and iron
Tablets
Other Names:
  • Ulipristal acetate
Experimental: B (PGL4001 10mg)
PGL4001 10 mg (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
Drug: PGL4001 (ulipristal) and iron
tablets
Other Names:
  • Ulipristal acetate
Drug: PGL4001 (ulipristal) and iron
Tablets
Other Names:
  • Ulipristal acetate
Placebo Comparator: C (placebo)
PGL4001 matching placebo (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
Drug: PGL4001 matching placebo and iron
tablets
Other Names:
  • Placebo of ulipristal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Co-primary Endpoint: Percentage of Subjects With Reduction in Uterine Bleeding Defined as a Pictorial Blood-loss Assessment Chart (PBAC) Score <75 at End-of-treatment Visit (Week 13)
Time Frame: Week 13 visit

Uterine bleeding was assessed with the use of the PBAC, a validated self-reporting method to estimate menstrual blood loss.

Patients recorded daily the number of tampons and towels used and the degree to which individual items were soiled with blood (plus small or large clots). Monthly scores range from 0 (amenorrhea) to more than 500, with higher numbers indicating more bleeding.

A slightly stained tampon/towel scores 1, a partially stained tampon/towel scores 5, a completely saturated tampon scores 10 and a completely saturated towel scores 20. Small clots/flooding (2cm) score 1. Large clots/flooding (3cm) score 5.

Menorrhagia is defined as a PBAC > 100 during one menstrual period which approximates to a blood loss of > 80 mL. A PBAC of 400 corresponds to a blood loss of around 300 mL or approximately 80 tampons/towels used.

The week 13 PBAC score was calculated using the last 28 days of treatment.
Week 13 visit
Co-primary Endpoint: Percent Change in Total Myoma Volume Assessed by Magnetic Resonance Imaging (MRI) From Screening to End of Treatment Visit (Week 13 Visit)
Time Frame: Week 13
Percent change in total fibroid volume from screening to end of treatment visit (Week 13 visit) assessed by MRI and read centrally by a radiologist who was unaware of the study-group assignments. The total fibroid volume was the sum of the individual fibroid volumes.
Week 13

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PregLem SA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

September 18, 2008

First Submitted That Met QC Criteria

September 18, 2008

First Posted (Estimate)

September 19, 2008

Study Record Updates

Last Update Posted (Estimate)

December 13, 2012

Last Update Submitted That Met QC Criteria

December 11, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PGL07-021

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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