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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 December 2012 |
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Main ID: |
NCT00755755 |
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Date of registration:
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18/09/2008 |
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Primary sponsor: |
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Public title:
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PGL4001 Versus Placebo in Uterine Myomas
PEARLI |
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Scientific title:
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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 |
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Date of first enrolment:
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October 2008 |
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Target sample size:
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241 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00755755 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Countries of recruitment
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Czech Republic
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Hungary
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India
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Romania
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Russian Federation
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Ukraine
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Contacts
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Name:
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Dr Elke Bestel |
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Address:
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Telephone:
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Email:
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Affiliation:
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PregLem SA |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
50 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Uterine Myomas
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Intervention(s)
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Drug: PGL4001 (ulipristal) and iron
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Drug: PGL4001 matching placebo and iron
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Primary Outcome(s)
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Co-primary Endpoint: Percent Change in Total Myoma Volume Assessed by Magnetic Resonance Imaging (MRI) From Screening to End of Treatment Visit (Week 13 Visit)
[Time Frame: Week 13]
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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)
[Time Frame: Week 13 visit]
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Secondary ID(s)
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PGL07-021
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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