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

Primary Purpose

Uterine Fibroids

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
PGL4001, placebo
PGL4001, progestin
Sponsored by
PregLem SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uterine Fibroids

Eligibility Criteria

18 Years - 48 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Medical University Graz, department of obstetrics and gynecology
  • Medical University Vienna, department of obstetrics and gynecology
  • Cliniques Universitaires Saint-Luc
  • CHR de la citadelle
  • Cliniques Universitaires UCL de Mont-Godinne
  • Prywatna Klinika Polozniczo-Ginekologiczna
  • INVICTA Sp. Z o.o.
  • Private Practice
  • Private Practice
  • Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie Klinika Ginekologii Onkologicznej i Ginekologii
  • Private Practice
  • Private Practice
  • Centralny Szpital Kliniczny MSWiA w Warszawie, Klinika Poloznictwa, Chorob Kobiecych i Ginekologii Onkologicznej
  • Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wrocławiu, I Katedra i Klinika Ginekologii i Położnictwa
  • Institut Universitari Dexeus Departamento de Ginecología
  • Hospital Universitario Hebron, gynecology department
  • Hospital Clinic i provincial de Barcelona, gynecology department
  • Hospital General de Ciudad Real Gynecology
  • Hospital Universitario de Guadalajara Consultas de Ginecología (Planta 0)
  • Clinica Ginecologica CEOGA, departamento de Ginecologia
  • Private pratice
  • Hospital universitario 12 de Octubre, departamento de ginecologia
  • CHIP

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

A

B

Arm Description

Drug: PGL4001 10mg (oral tablets) for 3 months followed by a period of 10 days of placebo (oral tablets).

Drug: PGL4001 10mg (oral tablets) for 3 months followed by a period of 10 days of progestin (oral tablets).

Outcomes

Primary Outcome Measures

Efficacy endpoints
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).
Number and proportion of subjects experiencing open label treatment-emergent adverse events

Secondary Outcome Measures

Full Information

First Posted
July 1, 2010
Last Updated
January 14, 2016
Sponsor
PregLem SA
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1. Study Identification

Unique Protocol Identification Number
NCT01156857
Brief Title
PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata
Acronym
PEARLIII
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 Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
February 2012 (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 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.
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.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Drug: PGL4001 10mg (oral tablets) for 3 months followed by a period of 10 days of placebo (oral tablets).
Arm Title
B
Arm Type
Experimental
Arm Description
Drug: PGL4001 10mg (oral tablets) for 3 months followed by a period of 10 days of progestin (oral tablets).
Intervention Type
Drug
Intervention Name(s)
PGL4001, placebo
Other Intervention Name(s)
Ulipristal acetate
Intervention Description
PGL4001 10mg once daily (oral tablets) for 3 months followed by a period of 10 days of placebo (oral tablets).
Intervention Type
Drug
Intervention Name(s)
PGL4001, progestin
Other Intervention Name(s)
Ulipristal acetate
Intervention Description
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).
Primary Outcome Measure Information:
Title
Efficacy endpoints
Description
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).
Time Frame
From baseline to end of PGL4001 treatment (3months treatment) and to approximately 2 weeks after double blind treatment with progestin/placebo.
Title
Number and proportion of subjects experiencing open label treatment-emergent adverse events
Time Frame
From baseline to end of PGL4001 treatment (3months treatment)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
48 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Medical University Graz, department of obstetrics and gynecology
City
Graz
ZIP/Postal Code
8047
Country
Austria
Facility Name
Medical University Vienna, department of obstetrics and gynecology
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Cliniques Universitaires Saint-Luc
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
CHR de la citadelle
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Cliniques Universitaires UCL de Mont-Godinne
City
Yvoir
ZIP/Postal Code
5530
Country
Belgium
Facility Name
Prywatna Klinika Polozniczo-Ginekologiczna
City
Bialystok
ZIP/Postal Code
15-224
Country
Poland
Facility Name
INVICTA Sp. Z o.o.
City
Gdańsk
ZIP/Postal Code
80-895
Country
Poland
Facility Name
Private Practice
City
Katowice
ZIP/Postal Code
40-724
Country
Poland
Facility Name
Private Practice
City
Lodz
ZIP/Postal Code
90-602
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie Klinika Ginekologii Onkologicznej i Ginekologii
City
Lublin
ZIP/Postal Code
20-081
Country
Poland
Facility Name
Private Practice
City
Warszawa
ZIP/Postal Code
00-815
Country
Poland
Facility Name
Private Practice
City
Warszawa
ZIP/Postal Code
02-066
Country
Poland
Facility Name
Centralny Szpital Kliniczny MSWiA w Warszawie, Klinika Poloznictwa, Chorob Kobiecych i Ginekologii Onkologicznej
City
Warszawa
ZIP/Postal Code
02-507
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wrocławiu, I Katedra i Klinika Ginekologii i Położnictwa
City
Wroclaw
ZIP/Postal Code
50-369
Country
Poland
Facility Name
Institut Universitari Dexeus Departamento de Ginecología
City
Barcelona
ZIP/Postal Code
08028
Country
Spain
Facility Name
Hospital Universitario Hebron, gynecology department
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic i provincial de Barcelona, gynecology department
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital General de Ciudad Real Gynecology
City
Ciudad Real
ZIP/Postal Code
13005
Country
Spain
Facility Name
Hospital Universitario de Guadalajara Consultas de Ginecología (Planta 0)
City
Guadalajara
ZIP/Postal Code
19002
Country
Spain
Facility Name
Clinica Ginecologica CEOGA, departamento de Ginecologia
City
Lugo
ZIP/Postal Code
27002
Country
Spain
Facility Name
Private pratice
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Facility Name
Hospital universitario 12 de Octubre, departamento de ginecologia
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
CHIP
City
Malaga
ZIP/Postal Code
29010
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
24630081
Citation
Donnez J, Vazquez F, Tomaszewski J, Nouri K, Bouchard P, Fauser BC, Barlow DH, Palacios S, Donnez O, Bestel E, Osterloh I, Loumaye E; PEARL III and PEARL III Extension Study Group. Long-term treatment of uterine fibroids with ulipristal acetate ☆. Fertil Steril. 2014 Jun;101(6):1565-73.e1-18. doi: 10.1016/j.fertnstert.2014.02.008. Epub 2014 Mar 12.
Results Reference
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PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata

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