Mifepristone to Treat Uterine Fibroids

Study Overview
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Brief Summary
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Objectives: to evaluate the efficacy, safety and quality of life by using 2.5 and mifepristone 5 mg daily doses to treat uterine fibroids over 3 months with a 9 months follow-up period. The hypothesis of the study is that the 2.5 mg dosage resulted in a lesser reduction in fibroid size but a similar improvement in quality of life when compared to the 5 mg dose.

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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Treatment of Uterine Myoma With 2.5 or 5 mg Mifepristone Daily During 3 Months With 9 Months Post-treatment Follow-up. Randomized Clinical Trial.

Conditions
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Uterine Fibroids

Intervention / Treatment
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* Drug: Oral administration of mifepristone 2.5 mg daily for three months
* Drug: Oral administration of mifepristone 5 mg daily for three months


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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mifepristone 2.5 mg daily for three months<br>Experimental: 1 | Drug: Oral administration of mifepristone 2.5 mg daily for three months<br>* Experimental: 1<br>* Other names: Low doses of antiprogestins to treat uterine fibroids;|
| Experimental: Mifepristone 5 mg daily for three months<br>Experimental: 2 | Drug: Oral administration of mifepristone 5 mg daily for three months<br>* Experimental: 2<br>* Other names: Low doses of antiprogestins to treat uterine fibroids;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volume of the uterine leiomyomata with 2,5mg vs 5 mg daily of mifepristone after 3 months of treatment | Evaluate efficacy were the percentage changes in fibroid volumes before starting, 3 into treatment and 3, 6, and 9 months after its termination | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volume of the uterus with 2,5 mg vs 5 md daily of mifepristone after 3 months of treatment. | Evaluate efficacy were the percentage changes in uterus volumes before starting, 3 into treatment and 3, 6, and 9 months after its termination | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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leiomyoma, fibroid, mifepristone, antiprogestins