NCT01553123

Efficacy and Safety Study of Ulipristal Acetate in Females With Anemia Associated With Uterine Leiomyoma

A Randomized, Placebo Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Ulipristal Acetate in Women With Anemia Associated With Uterine Leiomyomas

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Watson Pharmaceuticals · Industry
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether ulipristal acetate is effective in the treatment of females with anemia associated with uterine leiomyomas. The safety of this product will also be evaluated.

Detailed description

This is a randomized, placebo controlled, multicenter study with parallel groups in order to evaluate the efficacy and safety of ulipristal acetate in female subjects with anemia associated with uterine leiomyomas. The objective of this study is to determine if daily ulipristal acetate with iron is more effective than iron alone.

Conditions

• Leiomyomas

Interventions

Type	Name	Description
DRUG	Ulipristal Acetate	once daily, oral
DRUG	Iron	once daily, dried ferrous sulfate

Timeline

• Start date: 2012-04-01
• Primary completion: 2013-11-01
• Completion: 2013-12-01
• First posted: 2012-03-13
• Last updated: 2013-02-07

Locations

47 sites across 1 country: United States