Efficacy Study of Vaginal Mifepristone to Treat Uterine Fibroids

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effect of daily dosage of vaginally mifepristone on reduction of uterine fibroids size and the symptoms associated with uterine fibroids.

Detailed Description
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Uterine fibroids are benign tumors of the uterus made up of smooth muscle and the extracellular matrix proteins Collagen and Elastin. They are exceptionally common; the cumulative incidence of a diagnosis of fibroids in women aged 25 to 45 is approximately 30 percent. Uterine fibroids can cause abnormal uterine bleeding, dysmenorrhea, lower back pain and non-cyclic pelvic pain. They also can contribute to symptoms related to an enlarging pelvic mass (e.g., urinary frequency or constipation). Uterine fibroids are also associated with an increased risk of complications of pregnancy, and with infertility, although it is unclear whether this association is causative. Symptoms associated with uterine fibroids can have a significant impact on quality of life, with scores on standard measures that are comparable to those for other major chronic diseases

Official Title
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The Effect of Vaginal Mifepristone on Reduction of Uterine Fibroids Size and the Symptoms Associated With the Fibroids - Pilot Study (Phase IIa)

Conditions
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Uterine Fibroid, Vaginal Bleeding.

Intervention / Treatment
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* Drug: mifepristone vaginal tablets


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Uninterested in fertility during the study. Premenopausal status. Active symptoms related to uterine fibroids. Subjects will be obligated to use non hormonal contraceptives during the study. Exclusion Criteria: Abnormal liver and renal function Participants with significant increase in uterine fibroids size during a short time. Exclusionary health problems contraindicating mifepristone included adrenal disease; sickle cell anemia; severe liver, respiratory, or renal disease; and blood clotting defect. Current use of steroids, anticoagulants, herbals, or botanicals with possible hormonal effects.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 53 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: antiprogestin<br>Daily use of 10 mg administrated per vagina | Drug: mifepristone vaginal tablets<br>* Daily use of 10 mg administrated per vagina for 3 months<br>* Other names: mifepristone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease of uterine fibroids volume by 25% and up. |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oral mifepristone, vaginal tablets