Overview

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

Status:
Completed
Trial end date:
2014-01-01
Target enrollment:
0
Participant gender:
Female
Summary
This is the long-term extension of a phase III, efficacy and safety open-label (protocol PGL09-026) with PGL4001 10mg tablets once daily for three months, blinded towards the administration of progestin or placebo tablets after end of PGL4001 treatment. This extension study consists of three periods of 3 months open-label PGL4001 treatment, each followed by ten days of double-blind treatment with progestin or placebo and then a period without treatment.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
PregLem SA
Treatments:
Progestins
Ulipristal acetate
Criteria
Inclusion Criteria:

- Subject completed visit 6 of PGL09-026 study, 10 to 18 days after menstruation
following end of treatment with PGL4001, and did not take medications forbidden by the
protocol.

Exclusion Criteria:

- Subject has a large uterine polyp (> 2cm).

- Subject has one or more ovarian cysts ≥ 4cm diagnosed by ultrasound during PGL09-026
study.

- Subject has abnormal hepatic function at re-test.

- Subject has clinically significant abnormal findings at visit A or any other medical
condition(s) or laboratory findings that, in the opinion of the investigator, might
jeopardize the subject's safety or interfere with study evaluations.

- Subject has a positive pregnancy test or is planning a pregnancy during the course of
the study.