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

Study Identifier
UL1309
CT.gov Identifier
NCT02147197
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Study Details

Medical Condition
  • Uterine Fibroids
  • Women's Health & Pregnancy - Other
    • Study Drug
  • Ulipristal acetate (UPA)
  • Placebo
    • Phase
    Phase 3
    Sex
    Female
    Age
    18 - 50 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Pre-menopausal women, 18-50 years, inclusive. * Cyclic abnormal uterine bleeding (heavy or prolonged). * Menstrual blood loss (MBL) of ≥ 80 mL as measured by the alkaline hematin method in the first 8 days of menses. * Minimum of one discrete leiomyoma observable by transvaginal ultrasound. * Endometrial biopsy without evidence of malignancy or atypical or non-atypical hyperplasia
    Exclusion Criteria:
    * History of uterine surgery that would interfere with the study endpoints. * Known coagulation disorder including bleeding disorder or clotting disorder. * History of, or current uterine, cervix, ovarian, or breast cancer. * Alanine transaminase (ALT), aspartate transaminase (AST), alkaline phosphatase (ALP), or total bilirubin two times or greater than the upper limit of normal rang

    Protocol Summary

    This study will evaluate the superiority of ulipristal acetate versus placebo for the treatment of abnormal uterine bleeding associated with uterine fibroids

    Study Locations

    Location
    Status
    Location
    Watson Investigational Site 125
    Tucson, Arizona, United States, 85710
    Status
    Not applicable
    Location
    Watson Investigational Site 102
    San Diego, California, United States, 92103
    Status
    Not applicable
    Location
    Watson Investigational Site 112
    Denver, Colorado, United States, 80209
    Status
    Not applicable
    Location
    Watson Investigational Site 115
    Lakewood, Colorado, United States, 80228
    Status
    Not applicable
    Location
    Watson Investigational Site 116
    Milford, Connecticut, United States, 06460
    Status
    Not applicable
    Location
    Watson Investigational Site 114
    Washington D.C., District of Columbia, United States, 20036
    Status
    Not applicable
    Showing {first} - {last} of {total} Results