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Clinical Trial 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.


Clinical Trial 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. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01553123
Study type Interventional
Source Watson Pharmaceuticals
Contact
Status Withdrawn
Phase Phase 3
Start date April 2012
Completion date December 2013

See also
  Status Clinical Trial Phase
Active, not recruiting NCT01514617 - Diffusion -and Perfusion Weighted MRI for Response Prediction of Symptomatic Leiomyomas Following Uterine Artery Embolization N/A
Completed NCT00839722 - Fertility After Uterine Artery Embolisation for the Treatment of Leiomyomas Phase 2
Completed NCT01592903 - Somatic Stem Cells in Leiomyomas? N/A