Mifepristone for Treatment of Uterine Fibroids

Study Overview
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Brief Summary
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The objectives of this study are to estimate the efficacy and safety of the daily administration of mifepristone 5 mg versus 10 mg for three months for the treatment of uterine fibroids. The hypothesis of the study is that both mifepristone doses reduce the volume of the myoma in about 40% after 3 months of treatment.

Detailed Description
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Women, in fertile age or in premenopausal status, presenting symptomatic uterine fibroids were randomly assigned to receive 5 mg or 10 of mifepristone. The diminishing of prevalence of symptoms attributable to uterine fibroids is the most important goal to achieve under both treatments. The possible side effects of mifepristone are slight and women's adherence to treatment is remarkable. Also the reduction of the volumes of the uterus and fibroids contribute to enhance the wellbeing of subjects.

Official Title
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Mifepristone 5 mg Versus 10 mg for the Treatment of Uterine Leiomyomata. A Randomized, Double Blinded Clinical Trial.

Conditions
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Uterine Fibroids

Intervention / Treatment
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* Drug: Mifepristone
* Drug: Mifepristone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symptomatic uterine leiomyomata Reproductive age or premenopausal Accepting the use of non hormonal contraception Conformity in keeping a monthly log of all episodes of vaginal bleeding during the treatment as well as all side effects of mifepristone Agreeing to have ultrasound examinations in every follow-up or evaluation visit Agreeing to two endometrial biopsies: one before starting treatment and another in the following 10 days after treatment termination. Exclusion Criteria: Pregnancy or desire to become pregnant Breastfeeding Hormonal contraception or any hormonal therapy received in the last three months Signs or symptoms of pelvic inflammatory disease Adnexal masses Abnormal or unexplained vaginal bleeding Suspected or diagnosed malignant neoplastic disease Signs or symptoms of mental illness Adrenal disease Sickle cell anemia Hepatic disease Renal disease Coagulopathy Any other severe or important disease Any contraindication to receiving antiprogestins

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Mifepristone 10 mg daily for three months | Drug: Mifepristone<br>* Oral administration of Mifepristone 10 mg daily for three months<br>* Other names: Low doses of antiprogestins to treat uterine fibroids.;|
| Experimental: 2<br>Mifepristone 5 mg daily for three months | Drug: Mifepristone<br>* Oral administration of Mifepristone 5 mg, daily for three months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volume of the uterine leiomyomata with 5 mg versus 10 mg daily of mifepristone after 3 months of treatment |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volume of the uterus with 5 mg versus 10 mg daily of mifepristone after 3 months of treatment |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Uterine fibroids, mifepristone, antiprogestins