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 @ 11:00 PM
Ignite Modification Date:
2025-12-24 @ 11:00 PM
NCT ID:
NCT01311869
Eligibility Criteria:
Inclusion Criteria:
* Female; Age: 18Y or older.
* Pre-menopausal.
* FSH level is less than 10 mIU/L.
* Have at least moderate uterine fibroid-related symptoms (score of 24 or higher according to UFS-QOL questionnaire.
* Have a total uterine volume greater than or equal to 160 cc by ultrasound measurement and at least one fibroid that is ≥ 2.5cm in diameter.
* Agree to use a double-barrier method (condoms, diaphragms) or other effective non-hormonal methods of contraception (abstinence, sterilization) throughout participation in the study to prevent pregnancy.
* Agree to report any pregnancy to the research staff immediately.
* Willing and able to give informed consent.
* Willing and able to comply with study requirements.
* Liver function (ALT, AST, Prothrombin time and concentration)to be≤ 1.5 times the upper limit of normal
Exclusion Criteria:
* Current or planned pregnancy during the study period.
* Menopausal, as indicated by elevated follicle stimulating hormone (FSH) serum level.
* Currently breast-feeding.
* Untreated abnormal pap smear.
* Presence of conditions other than fibroids contributing to pelvic pain and/or bleeding;
* Hemoglobin \< 8.0 mg/dl.
* Presence of adnexal masses or tenderness indicating the need for further evaluation or surgery.
* Grade III or IV hydronephrosis by ultrasound.
* Mental health disorder.
* Active substance abuse or dependence.
* Current or recent (within the past 3 months) use of the following medications: Oral or systemic corticosteroids, Hormones (estrogen, progestins, oral contraceptives), Danazol, anticoagulants, Herbal or botanical supplements with possible hormonal or EGCG effects. Use within the past six months of the gonadotropin releasing hormones (GnRH) analogs or Depo-Provera,
* Current or planned use during the study of any of the following medications/or products: ketoconazole, itraconazole, erythromycin, grapefruit juice, rifampin, St John's Wort, phenytoin, phenobarbital, or carbamazepine.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01311869
Study Brief:
Protocol Section:
NCT01311869