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

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.

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Key information

Conditions

Uterine Fibroids Leiomyoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue

Age range

18 year–48 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Medical University Vienna, department of obstetrics and gynecology, Vienna, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PGL4001, placebo, drug free period

Drug

PGL4001 10mg once daily (oral tablets) for 3 months followed by a period of 10 days of placebo (oral tablets) during 3 periods each ending with a drug free period until return of menses.

Other names: Ulipristal acetate

PGL4001, progestin, drug free period

Drug

PGL4001 10mg once daily (oral tablets) for 3 months followed by a period of 10 days of progestin Norethisterone acetate 10mg once daily (oral tablets) during 3 periods each ending with a drug free period until return of menses.

Other names: Ulipristal acetate

Primary outcomes

percentage of subjects in amennorrhoea at the end of each PGL4001 treatment course received

Time frame: From baseline to end of each PGL4001 treatment (3months treatment)

Sponsors and collaborators

Lead sponsor

PregLem SA

Industry

Registry information

Official study 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

Important dates

Study start: 2011
Primary completion: 2013
Study completion: 2014
First posted: Dec 2, 2010
Registry last updated: Jan 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed