PGL4001 Versus Placebo in Uterine Myomas (PEARLI)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
PregLem SA
ClinicalTrials.gov Identifier:
NCT00755755
First received: September 18, 2008
Last updated: December 11, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Uterine Myomas
Drug: PGL4001 (ulipristal) and iron
Drug: PGL4001 matching placebo and iron
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, 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

Resource links provided by NLM:


Further study details as provided by PregLem SA:

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) [ Time Frame: Week 13 visit ] [ Designated as safety issue: No ]

    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) [ Time Frame: Week 13 ] [ Designated as safety issue: No ]
    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.


Enrollment: 241
Study Start Date: October 2008
Study Completion Date: August 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: Placebo of ulipristal

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  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: NCT00755755

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

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: PregLem SA
ClinicalTrials.gov Identifier: NCT00755755     History of Changes
Other Study ID Numbers: PGL07-021
Study First Received: September 18, 2008
Results First Received: July 26, 2012
Last Updated: December 11, 2012
Health Authority: Hungary: National Institute of Pharmacy
Russia: Ministry of Health of the Russian Federation
Ukraine: State Pharmacological Center - Ministry of Health
Czech Republic: State Institute for Drug Control
Romania: National Medicines Agency
India: Drugs Controller General of India

Additional relevant MeSH terms:
Myoma
Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases
Iron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014