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 @ 10:55 PM
Ignite Modification Date:
2025-12-24 @ 10:55 PM
NCT ID:
NCT00152269
Eligibility Criteria:
Inclusion Criteria:
* Premenopausal women
* History of regular menstrual cycles (21-42 days)
* Diagnosis of uterine fibroid(s)
* Abnormal vaginal bleeding associated with uterine fibroids
* Otherwise in good health
* Agrees to undergo surgery (hysterectomy) or any other invasive procedure if the study medication fails
* Negative pregnancy test
* Agrees to Double-barrier method of contraception
* Pap smear with no evidence of malignancy or pre-malignant changes
* Endometrial biopsy with no significant histological disorder
Exclusion Criteria:
* Any abnormal lab or procedure result the study-doctor considers important
* Severe reaction(s) to or are currently using any hormone therapy
* History of osteoporosis or other bone disease
* Previous myomectomy with 1 year and/or previous uterine artery embolization within 6 months
* History of Polycystic Ovary Syndrome or prolactinoma
* MRI shows significant gynecologic disorder
* Uterine size \> 25 weeks gestation
* Hemoglobin \< 8 g/dL at Day -1
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00152269
Study Brief:
Protocol Section:
NCT00152269