Mifepristone to Treat Uterine Fibroids

NCT ID: NCT01786226

Last Updated: 2014-09-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2012-03-31

Brief Summary

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

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.

Conditions

Uterine Fibroids

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mifepristone 2.5 mg daily for three months

Experimental: 1

Group Type: EXPERIMENTAL

Oral administration of mifepristone 2.5 mg daily for three months

Intervention Type: DRUG

Experimental: 1

Mifepristone 5 mg daily for three months

Experimental: 2

Group Type: EXPERIMENTAL

Oral administration of mifepristone 5 mg daily for three months

Intervention Type: DRUG

Experimental: 2

Interventions

Oral administration of mifepristone 2.5 mg daily for three months

Experimental: 1

Intervention Type: DRUG

Oral administration of mifepristone 5 mg daily for three months

Experimental: 2

Intervention Type: DRUG

Other Intervention Names

Low doses of antiprogestins to treat uterine fibroids; Low doses of antiprogestins to treat uterine fibroids

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Mediterranea Medica S. L.

OTHER

Sponsor Role: lead

Responsible Party

Dr. Josep LLuis Carbonell i Esteve

Medical Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital Eusebio Hernández

Ciudad Habana, La Habana, Cuba

Countries

Cuba

References

Carbonell JL, Acosta R, Perez Y, Garces R, Sanchez C, Tomasi G. Treatment of Uterine Myoma with 2.5 or 5 mg Mifepristone Daily during 3 Months with 9 Months Posttreatment Followup: Randomized Clinical Trial. ISRN Obstet Gynecol. 2013 Jul 29;2013:649030. doi: 10.1155/2013/649030. eCollection 2013.

Reference Type: RESULT

PMID: 23984082 (View on PubMed)

Other Identifiers

Fibroma2.5normal

Identifier Type: -

Identifier Source: org_study_id