NCT00712595

Mifepristone for Treatment of Uterine Fibroids

Mifepristone 5 mg Versus 10 mg for the Treatment of Uterine Leiomyomata. A Randomized, Double Blinded Clinical Trial.

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Mediterranea Medica S. L. · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DRUG	Mifepristone	Oral administration of Mifepristone 10 mg daily for three months
DRUG	Mifepristone	Oral administration of Mifepristone 5 mg, daily for three months

Timeline

• Start date: 2007-01-01
• Primary completion: 2007-01-01
• Completion: 2009-03-01
• First posted: 2008-07-10
• Last updated: 2009-04-23

Locations

1 site across 1 country: Cuba