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

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.
ClinicalTrials.gov Identifier: NCT01642472
Recruitment Status : Completed
First Posted : July 17, 2012
Last Update Posted : January 8, 2016
Sponsor:
Information provided by (Responsible Party):
PregLem SA

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.


Condition or disease Intervention/treatment Phase
Uterine Fibroids Drug: Ulipristal Acetate - open label Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : July 2012
Primary Completion Date : March 2015
Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Ulipristal Acetate (PGL4001) 10mg
Ulipristal Acetate (PGL4001)10mg daily administration
Drug: Ulipristal Acetate - open label
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.
Other Name: PGL4001



Primary Outcome Measures :
  1. Myoma symptom control assessed with a Global Study Treatment Satisfaction Questionnaire [ Time Frame: 9 months ]
    Average score of the first 3 questions.

  2. Myoma symptom control assessed with a Global Study Treatment Satisfaction Questionnaire [ Time Frame: 18 months ]
    Average score of the first 3 questions.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

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 ClinicalTrials.gov identifier (NCT number): NCT01642472


Locations
Austria
Medical University Vienna
Vienna, Austria, 1090
Belgium
Cliniques Universitaires Saint-Luc, Gynécologie-Obstétrique,
Brussels, Belgium, 1200
CHR de la Citadelle
Liège, Belgium, 4000
Cliniques Universitaires UCL de Mont-Godinne
Yvoir, Belgium, 5530
Poland
Prywatna Klinika Polozniczo-Ginekologiczna
Bialystok, Poland, 15-224
INVICTA Sp. Z o.o.
Gdańsk, Poland, 80-895
Private practice
Katowice, Poland, 40-724
Prywatny Gabinet Lekarski Ginekologia I Poloznictwo Ultrasonografia
Lodz, Poland, 90-602
Specjalistyczny Gabinet Ginekologiczno-Polozniczy
Lublin, Poland, 20-064
Gabinet Lekarski Specjalistyczny "Sonus"
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
Spain
Hospital Universitario Vall Hebrón (Gynecology department) Edificio Maternal
Barcelona, Spain, 08035
Clinica Ginecologica CEOGA
Lugo, Spain, 27002
Private Practice
Madrid, Spain, 28009
HOSPITAL Universitario 12 de Octubre y Fundación de Investigación Biomédica Hospital 12 de Octubre
Madrid, Spain, 28041
Sponsors and Collaborators
PregLem SA
Investigators
Study Director: Elke Bestel, Dr PregLem SA

Responsible Party: PregLem SA
ClinicalTrials.gov Identifier: NCT01642472     History of Changes
Other Study ID Numbers: PGL11-024
First Posted: July 17, 2012    Key Record Dates
Last Update Posted: January 8, 2016
Last Verified: December 2015

Additional relevant MeSH terms:
Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases