Mifepristone to Treat Uterine Fibroids

Phase 3TerminatedNCT01786226

Mediterranea Medica S. L.220 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

220

Conditions

Uterine Fibroids

Interventions

Oral administration of mifepristone 2.5 mg daily for three monthsDRUG

Experimental: 1

Oral administration of mifepristone 5 mg daily for three monthsDRUG

Experimental: 2

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

Hospital Eusebio Hernández

Ciudad Habana, La Habana, Cuba

Outcomes

Primary Outcomes

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

Time frame: 3 months

Secondary Outcomes

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

Time frame: 3 months

Data from ClinicalTrials.gov

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