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:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2025-12-25 @ 3:37 AM
NCT ID:
NCT00874302
Eligibility Criteria:
Inclusion Criteria:
* At least one uterine fibroid must be identifiable and measurable by Transvaginal Ultrasound (TVU)
* Subject must have uterine fibroid-associated symptoms during the-screening visit
* Subject has menstrual cycle lasting from 20 to 40 days
* Other inclusion criteria may apply
Exclusion Criteria:
* Post-menopausal women or women likely to become post-menopausal during the study
* Subject with a significant organ abnormality or disease (based on the Investigator's judgment) that would in the opinion of the Investigator exclude the subject from participating
* Subject with any medical condition that, in the opinion of the Investigator, is not compatible with study procedures or which would prevent the subject from starting or completing the study, or interfere with the subject participating in this study.
* Subject who has had an acute illness within five days of study medication administration
* Subject with endometrial thickness of ≥ 18 mm on screening ultrasound or historically
* Subject with an abnormal screening endometrial biopsy including the presence of Endometrial Intraepithelial Neoplasia (EIN)
* Subject with an abnormal DEXA scan with a diagnosis or indication of osteoporosis at screening
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00874302
Study Brief:
Protocol Section:
NCT00874302