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

August 30, 2019 updated by: PregLem SA

A Phase III, Multicentre, Randomized, Double-blind Clinical Study, Investigating the Efficacy and Safety of Repeated 12-week Courses of Daily 5mg or 10mg Doses of PGL4001 for the Long-term Management of Symptomatic Uterine Fibroids

Phase III, multicentre, randomized, double-blind, parallel group, long-term study investigating the efficacy and safety of the 5mg and 10mg doses of PGL4001 for the treatment of uterine myoma.

Study Overview

Status

Completed

Conditions

Detailed Description

The target population is composed of pre-menopausal women with symptomatic uterine myoma(s) characterised by heavy bleeding.The main objective of this study is to assess the sustained efficacy and safety of long term on-off treatment with PGL4001 5 or 10mg doses on uterine bleeding, myoma size, pain and quality of life.

Study Type

Interventional

Enrollment (Actual)

451

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

      • Brussels, Belgium, 1200
        • Cliniques Universitaires Saint-Luc Gynécologie-Obstétrique
      • Leuven, Belgium, 3000
        • UZ Leuven campus Gasthuisberg
      • Liège, Belgium, 4000
        • CHU de Liège, CHR de la Citadelle Gynécologie-Obstétrique
      • Yvoir, Belgium, 5530
        • CHU Mont-Godinne
      • Brno, Czechia, 60200
        • Centrum ambulantni gynekologie a primarni pece
      • Brno, Czechia, 62500
        • FN Brno Gynekologicko - porodnická klinika
      • Hradec Kralove, Czechia, 50002
        • Sanatorium SANUS
      • Jihlava, Czechia, 58633
        • Nemocnice Jihlava Gynekologicko - porodnicke oddeleni
      • Olomouc, Czechia, 77200
        • G-CENTRUM Olomouc s.r.o.
      • Olomouc, Czechia, 77220
        • FN Olomouc, Porodnicko-Gynekologicka klinika
      • Praha 3, Czechia, 13000
        • Femina Sana, s.r.o.
      • Le Kremlin Bicêtre, France, 94275
        • Hopital Bicêtre - APHP
      • Paris, France, 75018
        • Hôpital Bichat, Service de Gynécologie Obstétrique
      • Tours, France, 37044
        • CHU Bretonneau Service de Gynécologie Obstétrique
      • Hamburg, Germany, 22159
        • Private Practice
      • Hamburg, Germany, 22359
        • Private Practice
      • Hannover, Germany, 30625
        • Medizinische Hochschule Hannover Klinik für Frauenheilkunde und Geburtshilfe
      • Hessen, Germany, 60322
        • Frauenarztpraxis
      • Magdeburg, Germany, 39112
        • Praxis für Frauenheilkunde, Klinische Forschung und Weiterbildung
      • München, Germany, 81675
        • Technische Universität München
      • Bekescsaba, Hungary, 5600
        • Rethy Pal Korhaz és Rendelointezet Szuleszeti es Nogyogyaszati Osztaly
      • Budapest, Hungary, 1135
        • Institution Robert Karoly Maganklinika
      • Debrecen, Hungary, 4024
        • Szent Anna Szuleszeti, Nogyogyaszati es Ultrahang Maganrendelo
      • Nyiregyhaza, Hungary, 4400
        • Jósa András Oktatókórház
      • Szekesfehervar, Hungary, 8000
        • Fejer Megyei Szent Gyorgy Korhaz Szuleszeti es Nogyogyaszati Osztaly
      • Szentes, Hungary, 6600
        • Szuleszeti es Nogyogyaszati Osztaly
      • Szolnok, Hungary, 5000
        • Sandor Dent Bt.
      • Catanzaro, Italy, 88100
        • Dipartimento di Ostetricia e Ginecologia, Università degli Studi di Catanzaro "Magna Graecia"
      • Roma, Italy, 00168
        • Policlinico Universitario "Agostino Gemelli"
      • Riga, Latvia, 1001
        • Riga 1. hospital
      • Riga, Latvia, LV-1005
        • Latvian Medical Marine Center
      • Riga, Latvia, LV-1010
        • Medical Company "ARS"
      • Kaunas, Lithuania, 49449
        • Saules family medicine center
      • Vilnius, Lithuania, 01118
        • Family Medicine Centre"Seimos Gydytojas"
      • Vilnius, Lithuania, 03225
        • Private Clinic "Maxmeda"
      • Vilnius, Lithuania, 05263
        • Private Clinic "Kardiolita"
      • Bucuresti, Romania, 011025
        • Centrul Medical SANA SRL
      • Bucuresti, Romania, 011426
        • Quantum Medical Center SRL Obstetrica-Ginecologie
      • Bucuresti, Romania, 012064
        • Fortis Medical Center SRL Obstetrica Ginecologie
      • Bucuresti, Romania, 020475
        • Spitalul Clinic Dr. I.Cantacuzino sectia Obstetrica-Ginecologie
      • Bucuresti, Romania, 020762
        • Centrul Medical EUROMED SRL, Departamentul de Obtetrica/Ginecologie
      • Iasi, Romania, 700398
        • Spitalul Clinic de Obstetrica
      • Kharkiv, Ukraine, 61176
        • Kharkiv City Perinatal Center Gynaecological Department #1
      • Odessa, Ukraine, 65039
        • Municipal Institution "Maternity Hospital #1" City Center of family planning
      • Zaporizhzhya, Ukraine, 69065
        • Maternity Hospital#4 Department of Gynaecology
      • Edinburgh, United Kingdom, EH16 4TJ
        • MRC Centre for Reproductive Health University of Edinburgh
      • London, United Kingdom, N18 1QX
        • North Middlesex University Hospital NHS Trust
      • Newcastle upon Tyne, United Kingdom, NE1 4LP
        • Women's Health, Royal Victoria Infirmary
      • Norwich, United Kingdom, NR47UY
        • Norfolk & Norwich University Hospital

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 a Body Mass Index (BMI) ≥ 18 and ≤ 40.
  • Have FSH levels ≤ 20 mIU/mL
  • Have excessive uterine bleeding due to myoma.
  • Have regular menstrual cycles
  • Have a myomatous uterus < 16 weeks with at least one myoma ≥ 3 cm in diameter.
  • If of childbearing potential the subject must be practicing a non-hormonal method of contraception.

Exclusion Criteria:

  • Has a history of or current uterine, cervical, ovarian or breast cancer.
  • Has a history of or current endometrium atypical hyperplasia or adenocarcinoma.
  • Has a known severe coagulation disorder.
  • Has a history of or current treatment for myoma with a Selective Progesterone Receptor Modulator (SPRM).
  • Has abnormal hepatic function at study entry.
  • Has a positive pregnancy test, 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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ulipristal acetate (PGL4001) 5mg
All subjects will be asked to take a 150mg size tablet (PGL4001 5mg or matching placebo: placebo 5) orally daily for repeated periods 84 days. The first treatment course will start on the first 4 days of menstruation and will be orally administered, once daily (1 tablet of 150mg size), for 84 days. The following three treatment courses should be started in the first two days of a menstrual period.
PGL4001 5 mg daily administration
Other Names:
  • Ulipristal Acetate, Esmya
Experimental: Ulipristal acetate (PGL4001) 10mg
All subjects will be asked to take a 300mg size tablet (PGL4001 10mg or matching placebo: placebo 10 ) orally daily for repeated periods 84 days. The first treatment course will start on the first 4 days of menstruation and will be orally administered, once daily (1 tablet of 300mg size), for 84 days. The following three treatment courses should be started in the first two days of a menstrual period.
PGL4001 10mg daily administration
Other Names:
  • Ulipristal Acetate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Subjects Who Are in Amenorrhea at the End of All Four Treatment Courses
Time Frame: 18 months study duration per subject (4 3-month intermittent treatment courses)
Amenorrhoea was defined as no more than 1 day of spotting within a 35 day interval. Subjects need to be in amenorrhoea at the end of all four treatment courses, i.e for at least 4x35 days.
18 months study duration per subject (4 3-month intermittent treatment courses)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Subjects Who Were in Amenorrhea at the End of Treatment Course 4
Time Frame: After 18 months
Amenorrhoea was defined as no more than 1 day of spotting within a 35 day interval.
After 18 months
Percentage of Subjects With Controlled Bleeding at the End of All 4 Treatment Courses
Time Frame: After 18 months

Controlled bleeding was defined as no episodes of heavy bleeding and a maximum of 8 days of bleeding during the last 56 days of a treatment course.

Subjects need to be in controlled bleeding at the end of all 4 treatment courses i.e. for at least 4x56 days.

After 18 months
Percentage of Change From Baseline to End of Treatment Course 4 in the Total Volume of the 3 Largest Fibroids
Time Frame: After 18 months

For the 3 largest myomas at baseline and the 3 largest myomas at the end of treatment course 4 identified by transvaginal ultrasound, length, height and depth were measured and the volume was estimated by applying the equation for the voulme of an ellipsoid (length x height x depht x π/6).

Subjects were exposed to 4 3-month intermittent courses.

After 18 months
Percentage of Change From Baseline to End of Treatment Course 4 in Quality of Life (Uterine Fibroid Symptom Severity (UFSQoL)
Time Frame: After 18 months

Quality of Life was assessed using a validated questionnaire measuring uterine fibroid symptom severity (UFSQoL) where lower scores indicate fewer symtoms and where a level of 23 has been reported for healthy subject (scale 0-100).

Subjects were exposed to 4 3-month intermittent courses.

After 18 months
Percentage of Change From Baseline to End of Treatment Course 4 in Quality of Life -Uterine Fibroid Health Related Quality of Life (HRQL)
Time Frame: 18 months

Quality of Life was measured using a validated uterine fibroid symptom questionnaire. Total score for health related quality of Life (HRQL) range from 0 to 100 with higher scores indicating better Quality of Life.

Subjects were exposed to 4 3-month intermittent courses.

18 months
Percentage of Change From Baseline to End of Treatment Course 4 in Pain Using a Visual Analogue Scale (VAS)
Time Frame: After 18 months

Pain was assessed using a Visual Analogue Scale (VAS) ranging from 0 to 100 with higher score indicating more severe pain.

Subjects were exposed to 4 3-month intermittent courses.

After 18 months

Collaborators and Investigators

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

Sponsor

Investigators

  • Study Director: Pablo Arrigada, MD, 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.

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

June 1, 2012

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

June 19, 2012

First Submitted That Met QC Criteria

June 25, 2012

First Posted (Estimate)

June 27, 2012

Study Record Updates

Last Update Posted (Actual)

September 4, 2019

Last Update Submitted That Met QC Criteria

August 30, 2019

Last Verified

August 1, 2019

More Information

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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