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 @ 3:33 AM
Ignite Modification Date:
2025-12-25 @ 3:33 AM
NCT ID:
NCT00133705
Eligibility Criteria:
Inclusion Criteria:
* Gender: Female
* Age: 18 - premenopausal
* Have at least moderate symptoms of menorrhagia or pelvic pain/pressure
* 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 size
* Have a score of equal to or greater than 39 on the Uterine Fibroid Symptom and Quality of Life scale
* Declined standard treatment options for symptomatic fibroids
* 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 and to report any exposure to pregnancy to the research staff immediately
* Willing and able to give informed consent
* Willing and able to comply with study requirements
Exclusion Criteria:
* Current or planned pregnancy during the study period
* Menopausal, as indicated by follicle stimulating hormone (FSH) level of the reference laboratory
* Currently breast-feeding
* Untreated abnormal pap smear
* Presence of conditions other than fibroids contributing to pain and/or bleeding
* Hemoglobin \< 9.0 mg/dl
* Presence of adnexal masses or tenderness indicating further evaluation or surgery
* Grade III or IV hydronephrosis by ultrasound
* Severe, active mental health disorder
* Active substance abuse or dependence
* Presence of any contraindication to mifepristone including:
* Adrenal insufficiency by history
* Sickle cell disease
* Active liver disease (liver function tests greater than 1.5 times upper range of normal)
* Severe, respiratory disease (P02 saturation\< 92%)
* Renal disease (serum creatinine \> 1.5 mg/dl)
* Blood clotting defect. (abnormal PT and PTT)
* Thromboembolic disease (history of deep vein thrombosis or pulmonary embolus)
* Current or recent (within the past 3 months) use of the following medications:
* Oral or systemic corticosteroids
* Hormones: estrogens, progestins, oral contraceptives
* Danazol, anticoagulants
* Herbal or botanical supplements with possible hormonal 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:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00133705
Study Brief:
Protocol Section:
NCT00133705