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 @ 6:59 PM
Ignite Modification Date:
2025-12-24 @ 6:59 PM
NCT ID:
NCT01156857
Eligibility Criteria:
Inclusion Criteria:
* Subject is a pre-menopausal woman aged between 18 and 48 years inclusive.
* Subject with a Body Mass Index ≥18 and ≤40.
* Subject with myomatous uterus size \< 16 weeks.
* Subject must have at least one uterine myoma of at least 3 cm diameter in size and no myoma larger than 10 cm diameter diagnosed by ultrasound.
* Subject complained of strong uterine bleeding.
* Subject is eligible for hysterectomy or myomectomy.
* Females of childbearing potential have to practice a non-hormonal method of contraception.
Exclusion Criteria:
* Subject has a history of or current uterus, cervix, ovarian or breast cancer.
* Subject has a history of endometrium hyperplasia or adenocarcinoma in a biopsy performed within the past 6 months or similar lesions in the screening biopsy.
* Subject has a known severe coagulation disorder.
* Subject has a history of treatment for myoma with a SPRM, including ulipristal acetate.
* Subject has abnormal hepatic function at study entry.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
48 Years
Study:
NCT01156857
Study Brief:
Protocol Section:
NCT01156857