PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata
NCT ID: NCT01642472
Last Updated: 2016-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
64 participants
INTERVENTIONAL
2012-07-31
2015-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata (PEARLIII-extension Study)
NCT01252069
PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata
NCT01156857
PGL4001 Versus Placebo in Uterine Myomas
NCT00755755
PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata
NCT01629563
PGL4001 Versus GnRH-agonist in Uterine Myomas
NCT00740831
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Ulipristal Acetate (PGL4001) 10mg
Ulipristal Acetate (PGL4001)10mg daily administration
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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 Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Females of childbearing potential are advised to practice a non-hormonal method of contraception.
Exclusion Criteria
* 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.
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
PregLem SA
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Elke Bestel, Dr
Role: STUDY_DIRECTOR
PregLem SA
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Medical University Vienna
Vienna, , Austria
Cliniques Universitaires Saint-Luc, Gynécologie-Obstétrique,
Brussels, , Belgium
CHR de la Citadelle
Liège, , Belgium
Cliniques Universitaires UCL de Mont-Godinne
Yvoir, , Belgium
Prywatna Klinika Polozniczo-Ginekologiczna
Bialystok, , Poland
INVICTA Sp. Z o.o.
Gdansk, , Poland
Private practice
Katowice, , Poland
Prywatny Gabinet Lekarski Ginekologia I Poloznictwo Ultrasonografia
Lodz, , Poland
Specjalistyczny Gabinet Ginekologiczno-Polozniczy
Lublin, , Poland
Gabinet Lekarski Specjalistyczny "Sonus"
Warsaw, , Poland
Centralny Szpital Kliniczny MSWiA w Warszawie, Klinika Poloznictwa, Chorob Kobiecych i Ginekologii Onkologicznej
Warsaw, , Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wrocławiu, I Katedra i Klinika Ginekologii i Położnictwa
Wroclaw, , Poland
Hospital Universitario Vall Hebrón (Gynecology department) Edificio Maternal
Barcelona, , Spain
Clinica Ginecologica CEOGA
Lugo, , Spain
Private Practice
Madrid, , Spain
HOSPITAL Universitario 12 de Octubre y Fundación de Investigación Biomédica Hospital 12 de Octubre
Madrid, , Spain
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PGL11-024
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.