Mifepristone to Treat Uterine Fibroids

• Status: Terminated
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mediterranea Medica S. L.
• Treatments: Mifepristone

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