Status:
COMPLETED
PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata
Lead Sponsor:
PregLem SA
Conditions:
Uterine Fibroids
Eligibility:
FEMALE
18-48 years
Phase:
PHASE3
Brief Summary
This is a multicentre, Phase III, efficacy and safety open-label study with PGL4001 10mg once daily for 3 months, blinded towards the administration of progestin or placebo after end of PGL4001 treatm...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
209 Patients enrolled
Trial Details
Trial ID
NCT01156857
Start Date
July 1 2010
End Date
February 1 2012
Last Update
January 15 2016
Active Locations (23)
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1
Medical University Graz, department of obstetrics and gynecology
Graz, Austria, 8047
2
Medical University Vienna, department of obstetrics and gynecology
Vienna, Austria, 1090
3
Cliniques Universitaires Saint-Luc
Brussels, Belgium, 1200
4
CHR de la citadelle
Liège, Belgium, 4000