PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata

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.

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 treatment.

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.