A Phase III, Randomized, Parallel Group, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of PGL4001 (Ulipristal) Versus Placebo for Pre-Operative Treatment of Symptomatic Uterine Myomas
18 Years
50 Years
Female
Uterine Myomas
Trial Information
A Phase III, Randomized, Parallel Group, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of PGL4001 (Ulipristal) Versus Placebo for Pre-Operative Treatment of Symptomatic Uterine Myomas
Inclusion Criteria:
- Be a pre-menopausal woman between 18 and 50 years inclusive.
- Have excessive uterine bleeding due to myoma.
- Have a myoma-related anaemia.
- Have a myomatous uterus with at least one myoma of ≥ 3 cm diameter in size.
- Be eligible for one surgical procedure: e.g. hysterectomy, myomectomy or others.
- If of childbearing potential the subject must be practicing a non-hormonal method of
contraception.
- Have a Body Mass Index (BMI) ≥ 18 and ≤ 40.
Exclusion Criteria:
- Has a history of or current uterine, cervical, ovarian or breast cancer.
- Has a history of or current endometrium atypical hyperplasia.
- Has a known severe coagulation disorder.
- Has a history of or current treatment for myoma with a Selective Progesterone
Receptor Modulator (SPRM) or a GnRH-agonist.
- Has abnormal hepatic function at study entry.
- Has a positive pregnancy test at baseline or is nursing or planning a pregnancy
during the course of the study.
- Has a current (within twelve months) problem with alcohol or drug abuse.
- Is currently enrolled in an investigational drug or device study or has participated
in such a study within the last 30 days.
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:
Co-primary Endpoint: Percentage of Subjects With Reduction in Uterine Bleeding Defined as a Pictorial Blood-loss Assessment Chart (PBAC) Score <75 at End-of-treatment Visit (Week 13)
Outcome Description:
Uterine bleeding was assessed with the use of the PBAC, a validated self-reporting method to estimate menstrual blood loss. Patients recorded daily the number of tampons and towels used and the degree to which individual items were soiled with blood (plus small or large clots). Monthly scores range from 0 (amenorrhea) to more than 500, with higher numbers indicating more bleeding. A slightly stained tampon/towel scores 1, a partially stained tampon/towel scores 5, a completely saturated tampon scores 10 and a completely saturated towel scores 20. Small clots/flooding (2cm) score 1. Large clots/flooding (3cm) score 5. Menorrhagia is defined as a PBAC > 100 during one menstrual period which approximates to a blood loss of > 80 mL. A PBAC of 400 corresponds to a blood loss of around 300 mL or approximately 80 tampons/towels used. The week 13 PBAC score was calculated using the last 28 days of treatment.
Outcome Time Frame:
Week 13 visit
Safety Issue:
No
Principal Investigator
Dr Elke Bestel
Investigator Role:
Study Director
Investigator Affiliation:
PregLem SA
Authority:
Hungary: National Institute of Pharmacy
Study ID:
PGL07-021
NCT ID:
NCT00755755
Start Date:
October 2008
Completion Date:
August 2010
Related Keywords:
- Uterine Myomas
- Myoma
- Leiomyoma
- Myofibroma
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