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PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata (PEARLext2)

Primary Purpose

Uterine Fibroids

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ulipristal Acetate - open label
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 - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Subject completed visit F - Follow-up of Pearl III extension study (PGL09-027) - without significant deviations.
  • Females of childbearing potential are advised to practice a non-hormonal method of contraception.

Exclusion Criteria:

  • Subject has a history of uterus surgery (e.g. hysterectomy, myomectomy) or uterine artery embolization in Pearl III extension (PGL09-027) or afterwards that would interfere with the study assessments.
  • Subject has taken or is likely to require treatment during the study with drugs that are not permitted by the study protocol.
  • Subject is lactating, has a positive pregnancy test at study start or is planning a pregnancy during the course of the study.
  • Subject has abnormal baseline findings, any other medical condition(s) or laboratory finding that, in the opinion of the investigator, might jeopardise the subject's safety or interfere with study evaluations.

Sites / Locations

  • Medical University Vienna
  • Cliniques Universitaires Saint-Luc, Gynécologie-Obstétrique,
  • CHR de la Citadelle
  • Cliniques Universitaires UCL de Mont-Godinne
  • Prywatna Klinika Polozniczo-Ginekologiczna
  • INVICTA Sp. Z o.o.
  • Private practice
  • Prywatny Gabinet Lekarski Ginekologia I Poloznictwo Ultrasonografia
  • Specjalistyczny Gabinet Ginekologiczno-Polozniczy
  • Gabinet Lekarski Specjalistyczny "Sonus"
  • 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
  • Hospital Universitario Vall Hebrón (Gynecology department) Edificio Maternal
  • Clinica Ginecologica CEOGA
  • Private Practice
  • HOSPITAL Universitario 12 de Octubre y Fundación de Investigación Biomédica Hospital 12 de Octubre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ulipristal Acetate (PGL4001) 10mg

Arm Description

Ulipristal Acetate (PGL4001)10mg daily administration

Outcomes

Primary Outcome Measures

Myoma symptom control assessed with a Global Study Treatment Satisfaction Questionnaire
Average score of the first 3 questions.
Myoma symptom control assessed with a Global Study Treatment Satisfaction Questionnaire
Average score of the first 3 questions.

Secondary Outcome Measures

Full Information

First Posted
July 10, 2012
Last Updated
January 7, 2016
Sponsor
PregLem SA
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1. Study Identification

Unique Protocol Identification Number
NCT01642472
Brief Title
PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata
Acronym
PEARLext2
Official Title
A Phase III, Multicentre, Extension Study Investigating the Efficacy and Safety of Repeated Intermittent 3-month Courses of Open-label Administration of Ulipristal Acetate, in Subjects With Symptomatic Uterine Myomas and Heavy Uterine Bleeding
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
April 2015 (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 phase III, multicentre, long-term open-label extension of the phase III study: Pearl IIIextension (PGL09-027). During Pearl III (PGL09-026) and subsequent Pearl III extension (PGL09-027), patients have been exposed to a total of 4 cycles of daily 3month open-label treatment with ulipristal acetate 10mg before entering the proposed study Pearl extension 2 (PGL11-024). This proposed study consists of 4 further consecutive courses of 3 months (84 days) open label ulipristal acetate 10mg once daily treatment each separated by a drug free period.

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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ulipristal Acetate (PGL4001) 10mg
Arm Type
Experimental
Arm Description
Ulipristal Acetate (PGL4001)10mg daily administration
Intervention Type
Drug
Intervention Name(s)
Ulipristal Acetate - open label
Other Intervention Name(s)
PGL4001
Intervention Description
Ulipristal Acetate (PGL4001) tablets 10mg orally daily for 3 months (84 days) for each treatment course. There are four 3-month treatment courses in this study.
Primary Outcome Measure Information:
Title
Myoma symptom control assessed with a Global Study Treatment Satisfaction Questionnaire
Description
Average score of the first 3 questions.
Time Frame
9 months
Title
Myoma symptom control assessed with a Global Study Treatment Satisfaction Questionnaire
Description
Average score of the first 3 questions.
Time Frame
18 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject completed visit F - Follow-up of Pearl III extension study (PGL09-027) - without significant deviations. Females of childbearing potential are advised to practice a non-hormonal method of contraception. Exclusion Criteria: Subject has a history of uterus surgery (e.g. hysterectomy, myomectomy) or uterine artery embolization in Pearl III extension (PGL09-027) or afterwards that would interfere with the study assessments. Subject has taken or is likely to require treatment during the study with drugs that are not permitted by the study protocol. Subject is lactating, has a positive pregnancy test at study start or is planning a pregnancy during the course of the study. Subject has abnormal baseline findings, any other medical condition(s) or laboratory finding that, in the opinion of the investigator, might jeopardise the subject's safety or interfere with study evaluations.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elke Bestel, Dr
Organizational Affiliation
PregLem SA
Official's Role
Study Director
Facility Information:
Facility Name
Medical University Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Cliniques Universitaires Saint-Luc, Gynécologie-Obstétrique,
City
Brussels
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
Prywatny Gabinet Lekarski Ginekologia I Poloznictwo Ultrasonografia
City
Lodz
ZIP/Postal Code
90-602
Country
Poland
Facility Name
Specjalistyczny Gabinet Ginekologiczno-Polozniczy
City
Lublin
ZIP/Postal Code
20-064
Country
Poland
Facility Name
Gabinet Lekarski Specjalistyczny "Sonus"
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
Hospital Universitario Vall Hebrón (Gynecology department) Edificio Maternal
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Clinica Ginecologica CEOGA
City
Lugo
ZIP/Postal Code
27002
Country
Spain
Facility Name
Private Practice
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Facility Name
HOSPITAL Universitario 12 de Octubre y Fundación de Investigación Biomédica Hospital 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain

12. IPD Sharing Statement

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PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata

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