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 @ 2:06 PM
Ignite Modification Date:
2025-12-24 @ 2:06 PM
NCT ID:
NCT00156195
Eligibility Criteria:
Inclusion Criteria:
* Women who have completed 12 months of treatment in study M01-390 or study M01-394 and their Visit 12 procedures, respectively
* Otherwise in good health
* Premenopausal based on Estrogen and FSH levels
* Agrees to use of double barrier method of contraception
* Adequate endometrial biopsy with no significant histological disorder
Exclusion Criteria:
* Any abnormal lab or procedure result(s) the study-doctor considers important
* Significant gynecological disorder such as confirmed endometrial polyp
* Hemoglobin \< 8.0 g/dL
* History of a blood-clotting disorder
* Any prior surgical and/or invasive procedure(s) for uterine fibroids that resulted in either a cure or made the symptoms go away.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00156195
Study Brief:
Protocol Section:
NCT00156195