Overview

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.