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PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata

Information source: PregLem SA
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Uterine Fibroids

Intervention: Ulipristal acetate - open label (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: PregLem SA

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.

Clinical Details

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 design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Myoma symptom control assessed with a Global Study Treatment Satisfaction Questionnaire

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

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.

Locations and Contacts

Medical University Vienna, Vienna 1090, Austria

Cliniques Universitaires Saint-Luc, Gynécologie-Obstétrique,, Brussels 1200, Belgium

CHR de la Citadelle, Liège 4000, Belgium

Cliniques Universitaires UCL de Mont-Godinne, Yvoir 5530, Belgium

Prywatna Klinika Polozniczo-Ginekologiczna, Bialystok 15-224, Poland

INVICTA Sp. Z o.o., Gdańsk 80-895, Poland

Private practice, Katowice 40-724, Poland

Prywatny Gabinet Lekarski Ginekologia I Poloznictwo Ultrasonografia, Lodz 90-602, Poland

Specjalistyczny Gabinet Ginekologiczno-Polozniczy, Lublin 20-064, Poland

Centralny Szpital Kliniczny MSWiA w Warszawie, Klinika Poloznictwa, Chorob Kobiecych i Ginekologii Onkologicznej, Warszawa 02-507, Poland

Gabinet Lekarski Specjalistyczny "Sonus", Warszawa 02-066, Poland

Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wrocławiu, I Katedra i Klinika Ginekologii i Położnictwa, Wroclaw 50-369, Poland

Hospital Universitario Vall Hebrón (Gynecology department) Edificio Maternal, Barcelona 08035, Spain

Clinica Ginecologica CEOGA, Lugo 27002, Spain

HOSPITAL Universitario 12 de Octubre y Fundación de Investigación Biomédica Hospital 12 de Octubre, Madrid 28041, Spain

Private Practice, Madrid 28009, Spain

Additional Information

Starting date: July 2012
Last updated: March 18, 2013

Page last updated: August 20, 2015

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