A Phase III, Multicentre, Randomized, Double-blind Clinical Study, Investigating the Efficacy and Safety of Repeated 12-week Courses of Daily 5mg or 10mg Doses of PGL4001 for the Long-term Management of Symptomatic Uterine Fibroids
Phase 3
18 Years
50 Years
18 Years
50 Years
Open (Enrolling)
Female
Uterine Fibroids.
Female
Uterine Fibroids.
Trial Information
A Phase III, Multicentre, Randomized, Double-blind Clinical Study, Investigating the Efficacy and Safety of Repeated 12-week Courses of Daily 5mg or 10mg Doses of PGL4001 for the Long-term Management of Symptomatic Uterine Fibroids
Inclusion Criteria:
- Be a pre-menopausal woman between 18 and 50 years inclusive.
- Have a Body Mass Index (BMI) ≥ 18 and ≤ 40.
- Have FSH levels ≤ 20 mIU/mL
- Have excessive uterine bleeding due to myoma.
- Have regular menstrual cycles
- Have a myomatous uterus < 16 weeks with at least one myoma ≥ 3 cm in diameter.
- If of childbearing potential the subject must be practicing a non-hormonal method of
contraception.
Exclusion Criteria:
- Has a history of or current uterine, cervical, ovarian or breast cancer.
- Has a history of or current endometrium atypical hyperplasia or adenocarcinoma.
- Has a known severe coagulation disorder.
- Has a history of or current treatment for myoma with a Selective Progesterone
Receptor Modulator (SPRM).
- Has abnormal hepatic function at study entry.
- Has a positive pregnancy test, 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, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Percentage of subjects who are in amenorrhea at the end of treatment.
Outcome Time Frame:
After 18 months
Safety Issue:
No
Principal Investigator
Elke Bestel, MD
Investigator Role:
Study Director
Investigator Affiliation:
PregLem SA
Authority:
Belgium: Federal Agency for Medicinal Products and Health Products
Study ID:
PGL11-006
NCT ID:
NCT01629563
Start Date:
June 2012
Completion Date:
June 2015
Related Keywords:
- Uterine Fibroids.
- Leiomyoma
- Myofibroma
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