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PGL4001 Versus Placebo in Uterine Myomas (PEARLI)

Primary Purpose

Uterine Myomas

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
PGL4001 (ulipristal) and iron
PGL4001 matching placebo and iron
PGL4001 (ulipristal) and iron
Sponsored by
PregLem SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uterine Myomas

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Gynekologicko-porodnicka klinika FN Brno
  • Mediva
  • Gynekologicko-porodnicka klinika 1.LF UK a VFN
  • Gynekologicko-porodnicka klinika UK 2.LF a FN
  • Rethy-Pal Hospital-Clinic Bekescsaba, Department of Obstetrics and Gynecology
  • Saint Stephen Hospital of Budapest,Department of Obstetrics, Gynecology and Gynecological Oncology
  • Fovarosi Bajcsy-Zsilinszky Hospital, Department of Obstetrics and Gynecology
  • Saint George Hospital of Fejer County, Department of Obstetrics and Gynecology
  • Dr. Bugyi Istvan Hospital, Department of Obstetrics and Gynecology
  • Saint Borbala Hospital of Komarom-Esztergom County, Department of Obstetrics and Gynecology
  • Dr. Jilla Hospital
  • M. S. Ramaiah Medical College and Memorial Hospital
  • Divakars Speciality Hospital
  • Sri Ramachandra Medical College and Research Institute
  • Om Women's Hospital
  • Nagpur Test Tube Baby Centre
  • Central Medical Sanador
  • Departamentul de Obstretica Ginecologie si Nou Nascuti
  • Sectia Obstretica-Ginecologie Spitalul Clinic Dr. Ioan Cantacuzino
  • Centrul Medical Euromed, departementul de Obstetrica/Ginecologie
  • Spitalul Clinic de Obstetrica Ginecologie Oradea
  • Spitalul Clinic Judetean de urgenta, sectia de obstetrica Ginecologie I
  • Northern State Medical University
  • Kursk State Medical University
  • OAO "Medical company IDK"
  • American Medical Clinic
  • Saint-Petersburg City Alexandrovsky Hospital
  • Military Medical Academy n.a.S.M Kirov, chair of Obstetrics and Gynecology
  • Medical Research Institute (MRI)
  • Russian Scientific Research Center of Radiology and Surgical Technologies
  • Scientific Research Institute of Obstetrics and Gynecology n.a. D.O.Ott of RAMS
  • Donetsk National Medical University, Department of Obstetrics, Gynecology and Perinatology FPE
  • City Clinical Hospital N9
  • Institute of Pediatrics, Obstetrics and Gynecology, Department of Endocrine Gynecology
  • Kiev Maternity Hospital No.2
  • State Enterprise "Institute of Pediatrics, Obstetrics and Gynecology of AMS of Ukraine
  • Lviv National Medical University named after Danylo Halytskyy
  • Medical Sanitory Centre VAT "Motor Sich" Gynecology department

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

A (PGL4001 5mg)

B (PGL4001 10mg)

C (placebo)

Arm Description

PGL4001 5 mg (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+

PGL4001 10 mg (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+

PGL4001 matching placebo (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+

Outcomes

Primary Outcome Measures

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)
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.
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)
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.

Secondary Outcome Measures

Full Information

First Posted
September 18, 2008
Last Updated
December 11, 2012
Sponsor
PregLem SA
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1. Study Identification

Unique Protocol Identification Number
NCT00755755
Brief Title
PGL4001 Versus Placebo in Uterine Myomas
Acronym
PEARLI
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PregLem SA

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Myomas

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
241 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A (PGL4001 5mg)
Arm Type
Experimental
Arm Description
PGL4001 5 mg (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
Arm Title
B (PGL4001 10mg)
Arm Type
Experimental
Arm Description
PGL4001 10 mg (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
Arm Title
C (placebo)
Arm Type
Placebo Comparator
Arm Description
PGL4001 matching placebo (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
Intervention Type
Drug
Intervention Name(s)
PGL4001 (ulipristal) and iron
Other Intervention Name(s)
Ulipristal acetate
Intervention Description
tablets
Intervention Type
Drug
Intervention Name(s)
PGL4001 matching placebo and iron
Other Intervention Name(s)
Placebo of ulipristal
Intervention Description
tablets
Intervention Type
Drug
Intervention Name(s)
PGL4001 (ulipristal) and iron
Other Intervention Name(s)
Ulipristal acetate
Intervention Description
Tablets
Primary Outcome Measure Information:
Title
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)
Description
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.
Time Frame
Week 13 visit
Title
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)
Description
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.
Time Frame
Week 13

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
22296075
Citation
Donnez J, Tatarchuk TF, Bouchard P, Puscasiu L, Zakharenko NF, Ivanova T, Ugocsai G, Mara M, Jilla MP, Bestel E, Terrill P, Osterloh I, Loumaye E; PEARL I Study Group. Ulipristal acetate versus placebo for fibroid treatment before surgery. N Engl J Med. 2012 Feb 2;366(5):409-20. doi: 10.1056/NEJMoa1103182.
Results Reference
result
PubMed Identifier
24457604
Citation
Barlow DH, Lumsden MA, Fauser BC, Terrill P, Bestel E. Individualized vaginal bleeding experience of women with uterine fibroids in the PEARL I randomized controlled trial comparing the effects of ulipristal acetate or placebo. Hum Reprod. 2014 Mar;29(3):480-9. doi: 10.1093/humrep/det467. Epub 2014 Jan 23.
Results Reference
derived

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PGL4001 Versus Placebo in Uterine Myomas

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