PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata

• Status: Completed
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: Female

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 treatment.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: PregLem SA
• Treatments: Progestins; Ulipristal acetate

Criteria

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.