Status:
COMPLETED
Trial of Mifepristone for Fibroids
Lead Sponsor:
University of Rochester
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Leiomyoma
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this trial is to determine if low-dose mifepristone benefits women with symptomatic fibroids.
Detailed Description
This trial is designed to assess the efficacy and tolerability of mifepristone 5 mg given daily for 6 months to pre-menopausal women with symptomatic fibroids. The primary study outcome will be diseas...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00133705
Start Date
July 1 2003
End Date
June 1 2010
Last Update
September 25 2023
Active Locations (1)
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1
University of Rochester School of Medicine & Dentistry
Rochester, New York, United States, 14642