Study of Ulipristal Acetate in Female Patients With Moderately or Severely Impaired Renal Function, Compared With Matched Healthy Female Subjects

Study Identifier
UPA-PK-02
CT.gov Identifier
EudraCT Identifier
Not available
EUCTIS ID
Not available
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Study Complete

Study Details

Medical Condition
  • Renal Impairment
  • Study Drug
  • Ulipristal acetate
  • Phase
    Phase 1
    Sex
    Female
    Age
    18 - 80 Years

    Protocol Summary

    This study is designed to observe the effect of renal function on the pharmacokinetic, safety, and tolerability profiles of Ulipristal acetate following administration of a single oral dose of a 10 mg Ulipristal acetate tablet.

    Study Locations

    Location
    Status
    Location
    Division of Clinical Pharmacology, University of Miami
    Miami, Florida, United States, 33104
    Status
    Not applicable
    Location
    Clinical Pharmacology of Miami
    Miami, Florida, United States, 33136
    Status
    Not applicable
    Location
    Orlando Clinical Research Center
    Orlando, Florida, United States, 32809
    Status
    Not applicable
    Location
    Prism Clinical Research
    Saint Paul, Minnesota, United States, 55114
    Status
    Not applicable
    Location
    QPS Bio-Kinetic
    Springfield, Missouri, United States, 65802
    Status
    Not applicable