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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


Phase 3
18 Years
N/A
Open (Enrolling)
Female
Uterine Fibroids

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Myoma symptom control assessed with a Global Study Treatment Satisfaction Questionnaire

Outcome Description:

Average score of the first 3 questions.

Outcome Time Frame:

After 18 months.

Safety Issue:

No

Authority:

Belgium: Federal Agency for Medicinal Products and Health Products

Study ID:

PGL11-024

NCT ID:

NCT01642472

Start Date:

July 2012

Completion Date:

November 2014

Related Keywords:

  • Uterine Fibroids
  • Leiomyoma
  • Myofibroma

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