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 @ 11:32 PM
Ignite Modification Date:
2025-12-24 @ 11:32 PM
NCT ID:
NCT00156156
Eligibility Criteria:
Inclusion Criteria:
* Women who have completed 12 months of active treatment in study M01-391 and Month 12 visit procedures Or completed 18 months of active treatment in study C03-062 and Month 18 visit procedures (with no more than a 14-day interruption in dosing from study C02-062 and this study) OR could not continue in a previous asoprisnil study, but are now eligible for retreatment
* Otherwise in good health
* Premenopausal based on Estrogen and FSH levels
* Adequate endometrial biopsy with no significant histological disorder
* Agrees to use double-barrier method of contraception
Exclusion Criteria:
* Any abnormal lab or procedure result(s) the study-doctor considers important
* History of a blood-clotting disorder
* History of osteoporosis requiring treatment
* Any invasive procedure(s) (D\&C, etc) where a polyp was confirmed or a surgical or invasive procedure for uterine fibroids was performed during any previous asoprisnil study
* Hemoglobin \< 8.0 g/dL
* Endometrial thickness ≥ 19 mm
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00156156
Study Brief:
Protocol Section:
NCT00156156