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
18 Years
48 Years
Female
Uterine Fibroids
Trial Information
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
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
Efficacy endpoints
Outcome Description:
Investigate sustained efficacy of PGL4001 on uterine bleeding (% of subjects in amenorrhea at end of PGL4001 treatment), myoma size (transvaginal ultrasound), pain (short Mc Gill questionnaire) and quality of life (specific Uterine Fibroid Symptom and Quality of Life [UFS-QoL] questionnaire and general EQ-5D questionnaire).
Outcome Time Frame:
From baseline to end of PGL4001 treatment (3months treatment) and to approximately 2 weeks after double blind treatment with progestin/placebo during three successive periods each ended by a drug free period until return of menses.
Safety Issue:
No
Authority:
Belgium: Federal Agency for Medicinal Products and Health Products
Study ID:
PGL09-027
NCT ID:
NCT01252069
Start Date:
January 2011
Completion Date:
January 2014
Related Keywords:
- Uterine Fibroids
- Leiomyoma
- Myofibroma
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