NCT00886873

Mifepristone 10 or 5 mg for 6 Months to Treat Uterine Fibroids

Mifepristone 5 mg Versus 10 mg During 6 Months for the Treatment of Uterine Leiomyomata. A Randomized, Double Blinded Clinical Trial.

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 100 (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 for 6 months of 5 mg versus 10 mg. A 6 month follow-up of subjects is carried out to estimate how the effects of mifepristone are kept in time. The hypothesis of this study is that both mifepristone doses reduce the volume of the myoma up to 50% in six months treatment.

Detailed description

Women, in fertile age or premenopausal status, presenting symptomatic myomaswere randomly assigned to receive 5 or 10 mg of mifepristone for six months. The decreasing in the prevalence of symptoms attributable to myomas is an important goal to achieve under both treatments. Another goal is to maintain for more than 6 months the benefits of the treatment with mifepristone.

Conditions

• Uterine Fibroids

Interventions

Type	Name	Description
DRUG	Mifepristone

Timeline

• Start date: 2008-05-01
• Primary completion: 2009-04-01
• Completion: 2009-05-01
• First posted: 2009-04-23
• Last updated: 2014-10-17

Locations

1 site across 1 country: Cuba