Mifepristone for Treatment of Uterine Fibroids

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• 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