Trial of Mifepristone for Fibroids

Study Overview
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Brief Summary
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The purpose of this trial is to determine if low-dose mifepristone benefits women with symptomatic fibroids.

Detailed Description
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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 disease-specific quality of life. Secondary outcome measures include global quality of life, pain, bleeding, potential adverse effects, tumor size, and endometrial effects. The researchers will also examine a the effect of mifepristone on uterine blood flow. Randomization of study subjects will be stratified in order to ensure that equal numbers of women with moderate and severe symptoms will be enrolled in the placebo and control groups.

Official Title
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Randomized Control Trial Of Mifepristone for Fibroids

Conditions
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Leiomyoma

Intervention / Treatment
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* Drug: Mifepristone
* Drug: Inert Capsule


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mifepristone<br>Mifepristone 5 MG capsule taken once daily by mouth | Drug: Mifepristone<br>* Mifepristone 5mg/day by mouth for 6 months<br>* Other names: RU486;|
| Placebo Comparator: Inert capsule<br>Placebo (for Mifepristone) capsule of nearly identical color, size, and weight taken once daily by mouth | Drug: Inert Capsule<br>* sugar pill<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uterine Volume | Uterine volume is measured in mLs | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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A benign tumor derived from smooth uterine muscle tissue.