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 @ 11:39 PM
Ignite Modification Date:
2025-12-24 @ 11:39 PM
NCT ID:
NCT03070951
Eligibility Criteria:
Key Inclusion Criteria:
* Premenopausal woman at screening.
* Body Mass Index ≥ 18 kg/m2.
* Menstrual cycles ≥ 21 days and ≤ 40 days.
* Presence of uterine fibroids.
* Heavy menstrual blood loss for each of the 2 menstrual periods assessed at screening using the alkaline hematin method.
Key Exclusion Criteria:
* The subject is pregnant or breast-feeding or is planning a pregnancy within the duration of the treatment period of the study.
* History of uterus surgery that would interfere with the study.
* The subject's condition is so severe that she will require surgery within 6 months regardless of the treatment provided.
* Undiagnosed abnormal uterine bleeding.
* Significant risk of osteoporosis or history of, or known osteoporosis or other metabolic bone disease.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT03070951
Study Brief:
Protocol Section:
NCT03070951