This is a Phase IIb multicenter, open-label, non-comparative trial of continuous daily oral 10 mg of ulipristal acetate (UPA) to evaluate its contraceptive efficacy as the primary method of contraception.
This is an open-label study being conducted at 18 centers. The dose of 10 mg was chosen for daily continuous use of ulipristal acetate (UPA). The study will enroll approximately 300 subjects to use the UPA for 6 months (182 days). In addition to contraceptive efficacy, safety, overall acceptability of the product, and the number of bleeding/spotting days will be assessed.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Ulipristal aceteate 5 mg oral tablets to take two tablets daily.
Essential Access
Los Angeles, California, United States
University of California, Davis
Sacramento, California, United States
Evaluate the contraceptive efficacy at 6 months based on the calculated Pearl Index for the evaluable for pregnancy population.
Time frame: 6 months
Incidence of treatment emergent adverse events (safety and tolerability) during 6 month use of UPA.
Time frame: 6 months
Changes from baseline in sodium levels (safety and tolerability).
Time frame: 6 months
Changes from baseline in potassium levels (safety and tolerability).
Time frame: 6 months
Changes from baseline in chloride levels (safety and tolerability).
Time frame: 6 months
Changes from baseline in bicarbonate levels (safety and tolerability).
Time frame: 6 months
Changes from baseline in fasting glucose levels (safety and tolerability).
Time frame: 6 months
Changes from baseline in blood urea nitrogen levels (safety and tolerability).
Time frame: 6 months
Changes from baseline in creatinine levels (safety and tolerability).
Time frame: 6 months
Changes from baseline in calcium levels (safety and tolerability).
Time frame: 6 months
Changes from baseline in total bilirubin levels (safety and tolerability).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of California, San Francisco
San Francisco, California, United States
University of Colorado
Denver, Colorado, United States
University of Hawaii
Honolulu, Hawaii, United States
University of Chicago
Chicago, Illinois, United States
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States
Planned Parenthood League of Massachusetts
Boston, Massachusetts, United States
New York University, School of Medicine
New York, New York, United States
Columbia University
New York, New York, United States
...and 8 more locations
Time frame: 6 months
Changes from baseline in total alkaline phosphatase levels (safety and tolerability).
Time frame: 6 months
Changes from baseline in total alanine aminotransferase levels (safety and tolerability).
Time frame: 6 months
Changes from baseline in total aspartate transaminase levels (safety and tolerability).
Time frame: 6 months
Changes from baseline in total albumin levels (safety and tolerability).
Time frame: 6 months
Changes from baseline in total cholesterol levels (safety and tolerability).
Time frame: 6 months
Changes from baseline in HDL cholesterol levels (safety and tolerability).
Time frame: 6 months
Changes from baseline in LDL cholesterol levels (safety and tolerability).
Time frame: 6 months
Changes from baseline in triglycerides levels (safety and tolerability).
Time frame: 10 months
Changes from baseline in acceptability of UPA using an Acceptability Questionnaire (acceptability).
Time frame: 6 months
Changes from baseline in bleeding pattern using a subject diary (tolerability).
Time frame: 6 months
Changes from baseline in endometrial thickness using transvaginal ultrasound.
Time frame: 6 months
Changes from baseline in endometrium using endometrial biopsy results.
Time frame: 6 months