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

Inclusion Criteria for Patients with Renal Impairment:

- 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)

Exclusion Criteria:

- 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
impairment)

- 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
surface antigen, or anti-hepatitis C virus at screening

- Abnormal and clinically significant results on physical examination, medical history,
serum 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
screening 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

- Breastfeeding