Last updated on September 2016

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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Renal Function
  • Age: Between 18 - 80 Years
  • Gender: Female
  • Other:
    Have a negative result from a serum pregnancy test at screening and a negative result
    from a serum or urine pregnancy test on Day -1
    If premenopausal, have regular menstrual cycles (cycles of 24-35 days duration) over
    the past 6 months as reported by the patient
    If female of childbearing potential, agree to use an effective method of
    contraception (i.e., condom plus diaphragm with spermicide, condom with spermicide,
    or nonhormonal intrauterine device) and not become pregnant throughout the study.
    Subjects who are at least 2-years postmenopausal (with supporting documentation from
    an obstetrician/gynecologist) or who have had tubal ligation or hysterectomy will not
    be considered to be of childbearing potential
    Be nonsmoking (never smoked or have not smoked within the previous 6 months) or a
    light smoker (fewer than 10 cigarettes per day within the previous 3 months)
    For Patients with Renal Impairment, have medical history, physical examination,
    laboratory, and other test results consistent with their degree of renal impairment,
    as determined by the Investigator
    For Patients with Normal Renal Function, have a state of general good health based on
    medical history and routine physical examination and are matched to the age and
    weight of the renal dysfunction patients (mean group difference ±10 years for age and
    < 20% for weight)

You may not be eligible for this study if the following are true:

  • Known hypersensitivity to Ulipristal Acetate (UPA) or other selective progesterone
    receptor modulators
    For Patients with Renal Impairment, clinically significant disease state, in the
    opinion of the examining physician, in any body system (other than renal function
    For Patients with Normal Renal Function, clinically significant disease state, in the
    opinion of the examining physician, in any body system
    Positive test results for anti-human immunodeficiency virus type 1, hepatitis B
    urface antigen, or anti-hepatitis C virus at screening
    Abnormal and clinically significant results on physical examination, medical history,
    erum chemistry, hematology, or urinalysis
    History of alcohol or other substance abuse within the previous 5 years
    Positive test results for benzoylecgonine (cocaine), methadone, barbiturates,
    amphetamines, benzodiazepines, alcohol, cannabinoids, opiates, or phencyclidine at
    creening or Day -1. Patients with Renal Impairment many be enrolled if the positive
    test result is due to prescription drug use and approved by the Principal
    Investigator and Sponsor Study Physician, on a case-by-case basis
    Participation in any other clinical investigation using an experimental drug
    requiring repeated blood or plasma draws within 30 days of IP administration
    Participation in a blood or plasma donation program within 60 or 30 days,
    respectively, of Investigational Product (IP) administration
    Previously participated in an investigational study of Ulipristal Acetate

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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