PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata (PEARLIII)

PregLem

Status and phase

Completed

Phase 3

Conditions

Uterine Fibroids

Treatments

Drug: PGL4001, placebo

Drug: PGL4001, progestin

Study type

Interventional

Funder types

Industry

Identifiers

NCT01156857

PGL09-026

Details and patient eligibility

About

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.

Full 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 progestin or matching placebo. Subjects will be randomly assigned to progestin or matching placebo arm with a 1:1 ratio.

Enrollment

209 patients

Sex

Female

Ages

18 to 48 years old

Volunteers

No Healthy Volunteers

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.