A Study of the Efficacy and Safety of Ulipristal Acetate Intermittent Treatment for Abnormal Uterine Bleeding Associated With Leiomyomas

Study Identifier
UL1208
CT.gov Identifier
NCT02147158
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:
    * Premenopausal 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 range.

    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 138
    Mesa, Arizona, United States, 85209
    Status
    Not applicable
    Location
    Watson Investigational Site 147
    Phoenix, Arizona, United States, 85032
    Status
    Not applicable
    Location
    Watson Investigational Site 106
    Scottsdale, Arizona, United States, 85251
    Status
    Not applicable
    Location
    Watson Investigational Site 124
    Tucson, Arizona, United States, 85712
    Status
    Not applicable
    Location
    Watson Investigational Site 155
    Little Rock, Arkansas, United States, 72205
    Status
    Not applicable
    Location
    Watson Investigational Site 155
    Encino, California, United States, 91436
    Status
    Not applicable
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