PGL4001 Versus Placebo in Uterine Myomas

• Status: Completed
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: Female

Summary

This trial will assess the efficacy and safety of PGL4001 with concomitant iron administration versus placebo with concomitant iron administration, over a 3-month period for the pre-operative treatment of pre-menopausal women suffering from excessive uterine bleeding due to uterine myoma.

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

Details

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

Criteria

Inclusion Criteria:

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

• Have excessive uterine bleeding due to myoma.

• Have a myoma-related anaemia.

• Have a myomatous uterus with at least one myoma of ≥ 3 cm diameter in size.

• Be eligible for one surgical procedure: e.g. hysterectomy, myomectomy or others.

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

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

Exclusion Criteria:

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

• Has a history of or current endometrium atypical hyperplasia.

• Has a known severe coagulation disorder.

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

• Has abnormal hepatic function at study entry.

• Has a positive pregnancy test at baseline or 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.