PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata (PEARLIII-extension Study) - Full Text View

Purpose

This is the long-term extension of a phase III, efficacy and safety open-label (protocol PGL09-026) with PGL4001 10mg tablets once daily for three months, blinded towards the administration of progestin or placebo tablets after end of PGL4001 treatment.

This extension study consists of three periods of 3 months open-label PGL4001 treatment, each followed by ten days of double-blind treatment with progestin or placebo and then a period without treatment.

Condition	Intervention	Phase
Uterine Fibroids	Drug: PGL4001, placebo, drug free period Drug: PGL4001, progestin, drug free period	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Phase III, Multicentre, Clinical Study Investigating the Efficacy and Safety of Three Successive Periods of 3-month Open-label PGL4001 Treatment, Each Followed by Ten Days of Double-blind Treatment With Progestin or Placebo and a Drug-free Period Until Return of Menses, in Subjects With Myomas and Heavy Uterine Bleeding

Resource links provided by NLM:

MedlinePlus related topics: Menstruation

Drug Information available for: Ulipristal acetate

U.S. FDA Resources

Further study details as provided by PregLem SA:

Primary Outcome Measures:

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 during three successive periods each ended by a drug free period until return of menses. ] [ Designated as safety issue: No ]
Investigate sustained 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 Uterine Fibroid Symptom and Quality of Life [UFS-QoL] questionnaire and general EQ-5D questionnaire).
Safety endpoints [ Time Frame: From baseline to end of PGL4001 treatment (3months treatment) and to approximately 2 weeks after double blind treatment with progestin/placebo during three successive periods each ended by a drug free period until return of menses. ] [ Designated as safety issue: Yes ]
Assess the overall safety of the on-off 3 months administration of PGL4001 for up to a total of four treatment cycles.

Number and proportion of subjects experiencing treatment-emergent adverse events observed by physical examination,vital signs, ECG, transvaginal ultrasound and laboratory parameters.
Exploratory endpoints [ Time Frame: From baseline to end of PGL4001 treatment (3months treatment) and to approximately 2 weeks after double blind treatment with progestin/placebo during three successive periods each ended by a drug free period until return of menses. ] [ Designated as safety issue: No ]
Assessment of the strengh of the first menstrual bleed after each PGL4001 treament using the Pictorial Bleeding Assessment Chart (PBAC).

Estimated Enrollment:	200
Study Start Date:	January 2011
Estimated Study Completion Date:	January 2014
Estimated Primary Completion Date:	August 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A PGL4001 10mg (oral tablets) for 3 months followed by a period of 10 days of placebo (oral tablets) during 3 periods each ended by a drug free period until return of menses.	Drug: PGL4001, placebo, drug free period PGL4001 10mg (oral tablets) for 3 months followed by a period of 10 days of placebo (oral tablets) during 3 periods each ended by a drug free period until return of menses. Other Name: Ulipristal acetate
Experimental: B PGL4001 10mg (oral tablets) for 3 months followed by a period of 10 days of progestin (oral tablets) during 3 periods each ended by a drug free period until return of menses.	Drug: PGL4001, progestin, drug free period PGL4001 10mg (oral tablets) for 3 months followed by a period of 10 days of progestin (oral tablets) during 3 periods each ended by a drug free period until return of menses. Other Name: Ulipristal acetate

Eligibility

Ages Eligible for Study:	18 Years to 48 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subject completed visit 6 of PGL09-026 study, 10 to 18 days after menstruation following end of treatment with PGL4001, and did not take medications forbidden by the protocol.

Exclusion Criteria:

Subject has a large uterine polyp (> 2cm).
Subject has one or more ovarian cysts ≥ 4cm diagnosed by ultrasound during PGL09-026 study.
Subject has abnormal hepatic function at re-test.
Subject has clinically significant abnormal findings at visit A or any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardize the subject's safety or interfere with study evaluations.
Subject has a positive pregnancy test or is planning a pregnancy during the course of the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01252069

Locations

Austria
Medical University Vienna, department of obstetrics and gynecology
Vienna, Austria, 1090
Belgium
Cliniques Universitaires Saint-Luc Gynécologie-Obstétrique
Bruxelles, Belgium, 1200
CHR de la Citadelle Gynécologie-Obstétrique
Liège, Belgium, 4000
Cliniques Universitaires UCL de Mont-Godinne Gynécologie-Obstétrique
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
Private practice
Lodz, Poland, 90-602
Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie Klinika Ginekologii Onkologicznej i Ginekologii
Lublin, Poland, 20-081
Centralny Szpital Kliniczny MSWiA w Warszawie, Klinika Poloznictwa, Chorob Kobiecych i Ginekologii Onkologicznej
Warszawa, Poland, 02-507
Private Practice
Warszawa, Poland, 00-815
Private practice
Warszawa, Poland, 02-066
Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wrocławiu, I Katedra i Klinika Ginekologii i Położnictwa
Wroclaw, Poland, 50-369
Spain
Hospital Universitario Hebron, gynecology department
Barcelona, Spain, 08035
Clinica Ginecologica CEOGA, departamento de Ginecologia
Lugo, Spain, 27002
Private Practice
Madrid, Spain, 28009
HOSPITAL Universitario 12 de Octubre y Fundación de Investigación Biomédica Hospital 12 de Octubre Departamento de Ginecología
Madrid, Spain, 28041
CHIP (Complejo Hospitalario Integral Privado)
Malaga, Spain, 29010

Sponsors and Collaborators

PregLem SA

More Information

No publications provided

Responsible Party:	Dr Elke Bestel, PregLem SA
ClinicalTrials.gov Identifier:	NCT01252069 History of Changes
Other Study ID Numbers:	PGL09-027
Study First Received:	November 30, 2010
Last Updated:	June 8, 2012
Health Authority:	Belgium: Federal Agency for Medicinal Products and Health Products Poland: Ministry of Health Austria: Federal Office for Safety in Health Care Spain: Agencia Española de Medicamentos y Productos Sanitarios

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
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013