A Phase III, Multicentre, Clinical Study Investigating the Efficacy and Safety of 3-months Open-label Treatment With PGL4001, Followed by a Randomised, Double-blind Placebo Controlled Period of 10 Days Treatment With Progestin, 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 3-months Open-label Treatment With PGL4001, Followed by a Randomised, Double-blind Placebo Controlled Period of 10 Days Treatment With Progestin, in Subjects With Myomas and Heavy Uterine Bleeding.
PGL4001 will be administered daily to all subjects in an open-label manner with no control
group. The three months open label treatment period will be followed by a ten day double
blind treatment with progestin or matching placebo. Subjects will be randomly assigned to
progestin or matching placebo arm with a 1:1 ratio.
Inclusion Criteria:
- Subject is a pre-menopausal woman aged between 18 and 48 years inclusive.
- Subject with a Body Mass Index ≥18 and ≤40.
- Subject with myomatous uterus size < 16 weeks.
- Subject must have at least one uterine myoma of at least 3 cm diameter in size and no
myoma larger than 10 cm diameter diagnosed by ultrasound.
- Subject complained of strong uterine bleeding.
- Subject is eligible for hysterectomy or myomectomy.
- Females of childbearing potential have to practice a non-hormonal method of
contraception.
Exclusion Criteria:
- Subject has a history of or current uterus, cervix, ovarian or breast cancer.
- Subject has a history of endometrium hyperplasia or adenocarcinoma in a biopsy
performed within the past 6 months or similar lesions in the screening biopsy.
- Subject has a known severe coagulation disorder.
- Subject has a history of treatment for myoma with a SPRM, including ulipristal
acetate.
- Subject has abnormal hepatic function at study entry.
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 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 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.
Safety Issue:
No
Authority:
Belgium: Federal Agency for Medicinal Products and Health Products
Study ID:
PGL09-026
NCT ID:
NCT01156857
Start Date:
July 2010
Completion Date:
February 2012
Related Keywords:
- Uterine Fibroids
- Leiomyoma
- Myofibroma
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