Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2025-12-24 @ 10:50 PM
NCT ID:
NCT01252069
Eligibility 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.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
48 Years
Study:
NCT01252069
Study Brief:
Protocol Section:
NCT01252069