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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01156857
Recruitment Status : Completed
First Posted : July 5, 2010
Last Update Posted : January 15, 2016
Information provided by (Responsible Party):
PregLem SA

Brief Summary:
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 or disease Intervention/treatment Phase
Uterine Fibroids Drug: PGL4001, placebo Drug: PGL4001, progestin Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 209 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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.
Study Start Date : July 2010
Actual Primary Completion Date : November 2011
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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 once daily (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 once daily (oral tablets) for 3 months followed by a period of 10 days of progestin Norethisterone acetate 10mg once daily (oral tablets).
Other Name: Ulipristal acetate

Primary Outcome Measures :
  1. 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. ]
    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).

  2. Number and proportion of subjects experiencing open label treatment-emergent adverse events [ Time Frame: From baseline to end of PGL4001 treatment (3months treatment) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 48 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01156857

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Medical University Graz, department of obstetrics and gynecology
Graz, Austria, 8047
Medical University Vienna, department of obstetrics and gynecology
Vienna, Austria, 1090
Cliniques Universitaires Saint-Luc
Bruxelles, Belgium, 1200
CHR de la citadelle
Liège, Belgium, 4000
Cliniques Universitaires UCL de Mont-Godinne
Yvoir, Belgium, 5530
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, 00-815
Private Practice
Warszawa, Poland, 02-066
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
Institut Universitari Dexeus Departamento de Ginecología
Barcelona, Spain, 08028
Hospital Universitario Hebron, gynecology department
Barcelona, Spain, 08035
Hospital Clinic i provincial de Barcelona, gynecology department
Barcelona, Spain, 08036
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
Private pratice
Madrid, Spain, 28009
Hospital universitario 12 de Octubre, departamento de ginecologia
Madrid, Spain, 28041
Malaga, Spain, 29010
Sponsors and Collaborators
PregLem SA

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: PregLem SA Identifier: NCT01156857     History of Changes
Other Study ID Numbers: PGL09-026
First Posted: July 5, 2010    Key Record Dates
Last Update Posted: January 15, 2016
Last Verified: June 2013

Additional relevant MeSH terms:
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Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Connective Tissue
Connective Tissue Diseases
Ulipristal acetate
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists