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

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

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

Brief 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 Summary: 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.
Sponsor: Watson Pharmaceuticals

Current Primary Outcome: Change from baseline in hemoglobin levels (g/dL) [ Time Frame: Day 1 of the first on-treatment menstrual cycle to the start, or scheduled start of menstrual cycle 3. ]

Change from baseline in hemoglobin levels (g/dL)


Original Primary Outcome: Hemoglobin Level [ Time Frame: Day 1 of the first on-treatment menstrual cycle to the start, or scheduled start of menstrual cycle 3. ]

Change from baseline in hemoglobin levels.


Current Secondary Outcome:

Original Secondary Outcome:

Information By: Watson Pharmaceuticals

Dates:
Date Received: March 2, 2012
Date Started: April 2012
Date Completion: December 2013
Last Updated: February 5, 2013
Last Verified: February 2013