NCT01642472

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2012

Typical duration for phase_3

Geographic Reach
4 countries

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

July 10, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 17, 2012

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

January 8, 2016

Status Verified

December 1, 2015

Enrollment Period

2.7 years

First QC Date

July 10, 2012

Last Update Submit

January 7, 2016

Conditions

Uterine Fibroids

Outcome Measures

Primary Outcomes (2)

  • Myoma symptom control assessed with a Global Study Treatment Satisfaction Questionnaire

    Average score of the first 3 questions.

    9 months

  • Myoma symptom control assessed with a Global Study Treatment Satisfaction Questionnaire

    Average score of the first 3 questions.

    18 months

Study Arms (1)

Ulipristal Acetate (PGL4001) 10mg

EXPERIMENTAL

Ulipristal Acetate (PGL4001)10mg daily administration

Drug: Ulipristal Acetate - open label

Interventions

Ulipristal Acetate - open labelDRUG

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.

Also known as: PGL4001
Ulipristal Acetate (PGL4001) 10mg

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Medical University Vienna

Vienna, 1090, Austria

Location

Cliniques Universitaires Saint-Luc, Gynécologie-Obstétrique,

Brussels, 1200, Belgium

Location

CHR de la Citadelle

Liège, 4000, Belgium

Location

Cliniques Universitaires UCL de Mont-Godinne

Yvoir, 5530, Belgium

Location

Prywatna Klinika Polozniczo-Ginekologiczna

Bialystok, 15-224, Poland

Location

INVICTA Sp. Z o.o.

Gdansk, 80-895, Poland

Location

Private practice

Katowice, 40-724, Poland

Location

Prywatny Gabinet Lekarski Ginekologia I Poloznictwo Ultrasonografia

Lodz, 90-602, Poland

Location

Specjalistyczny Gabinet Ginekologiczno-Polozniczy

Lublin, 20-064, Poland

Location

Gabinet Lekarski Specjalistyczny "Sonus"

Warsaw, 02-066, Poland

Location

Centralny Szpital Kliniczny MSWiA w Warszawie, Klinika Poloznictwa, Chorob Kobiecych i Ginekologii Onkologicznej

Warsaw, 02-507, Poland

Location

Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wrocławiu, I Katedra i Klinika Ginekologii i Położnictwa

Wroclaw, 50-369, Poland

Location

Hospital Universitario Vall Hebrón (Gynecology department) Edificio Maternal

Barcelona, 08035, Spain

Location

Clinica Ginecologica CEOGA

Lugo, 27002, Spain

Location

Private Practice

Madrid, 28009, Spain

Location

HOSPITAL Universitario 12 de Octubre y Fundación de Investigación Biomédica Hospital 12 de Octubre

Madrid, 28041, Spain

Location

MeSH Terms

Conditions

Leiomyoma

Condition Hierarchy (Ancestors)

Neoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Elke Bestel, Dr

    PregLem SA

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2012

First Posted

July 17, 2012

Study Start

July 1, 2012

Primary Completion

March 1, 2015

Study Completion

April 1, 2015

Last Updated

January 8, 2016

Record last verified: 2015-12

Locations

PL(8)AU(1)BE(3)ES(4)