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Completed

NCT Number: NCT01642472

PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata

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.

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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 and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Medical University Vienna, Vienna, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Ulipristal Acetate - open label

Drug

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 names: PGL4001

Primary outcomes

  1. Myoma symptom control assessed with a Global Study Treatment Satisfaction Questionnaire

    Time frame: 9 months

    Average score of the first 3 questions.

  2. Myoma symptom control assessed with a Global Study Treatment Satisfaction Questionnaire

    Time frame: 18 months

    Average score of the first 3 questions.

Sponsors and collaborators

Lead sponsor

PregLem SA

Industry

Registry information

Official study 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

Acronym: PEARLext2

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jul 17, 2012
Registry last updated
Jan 8, 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.

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