PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata

• Status: Completed
• Trial end date: 2015-01-01
• Target enrollment: 0
• Participant gender: Female

Summary

Phase III, multicentre, randomized, double-blind, parallel group, long-term study investigating the efficacy and safety of the 5mg and 10mg doses of PGL4001 for the treatment of uterine myoma.

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

Details

• Lead Sponsor: PregLem SA
• Treatments: Ulipristal acetate

Criteria

Inclusion Criteria:

• Be a pre-menopausal woman between 18 and 50 years inclusive.

• Have a Body Mass Index (BMI) ≥ 18 and ≤ 40.

• Have FSH levels ≤ 20 mIU/mL

• Have excessive uterine bleeding due to myoma.

• Have regular menstrual cycles

• Have a myomatous uterus < 16 weeks with at least one myoma ≥ 3 cm in diameter.

• If of childbearing potential the subject must be practicing a non-hormonal method of contraception.

Exclusion Criteria:

• Has a history of or current uterine, cervical, ovarian or breast cancer.

• Has a history of or current endometrium atypical hyperplasia or adenocarcinoma.

• Has a known severe coagulation disorder.

• Has a history of or current treatment for myoma with a Selective Progesterone Receptor Modulator (SPRM).

• Has abnormal hepatic function at study entry.

• Has a positive pregnancy test, is nursing or planning a pregnancy during the course of the study.

• Has a current (within twelve months) problem with alcohol or drug abuse.

• Is currently enrolled in an investigational drug or device study or has participated in such a study within the last 30 days.