A Study of the Efficacy and Safety of a 3-month Treatment Course of Ulipristal Acetate for the Treatment of Abnormal Uterine Bleeding Associated With Leiomyomas

Percentage of Participants With Absence of Bleeding From Day 11 Through the End of Treatment

Participants recorded bleeding in a daily diary. Absence of bleeding was defined as no bleeding days (i.e. no entries for bleeding or heavy bleeding; however, spotting was allowed), starting from Day 11 through the end of the 12-week Treatment Period.

Time frame: Day 11 through the end of the 12-week Treatment Period

Change From Baseline in Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire (UFS-QOL) Revised Activities Subscale Score at the End of Treatment Period

The UFS-QOL is a uterine fibroid-specific questionnaire consisting of 37 questions developed to evaluate symptoms of uterine fibroids and their impact on health-related quality of life in women with leiomyomas. The first 8 questions comprise the Symptom Severity subscale to assess symptoms experienced by women with uterine leiomyomas, the remaining 29 questions comprise 6 subscales (Concern, Activities, Energy/mood, Control, Self-consciousness, Sexual Function) which overall deal with women's feelings and experiences regarding impact of uterine leiomyoma symptoms on her life. Each item is scored between 1 and 5, where 1=none of the time or not at all and 5=all of the time or a very great deal. A Revised Activities subscale was created to include the most relevant items pertaining to physical and social activities with a total possible score of 0 to 100. Higher Revised Activities subscale scores indicate less impact on activities. A positive change from Baseline indicates improvement.