Efficacy Study of Two Continuous Regimens of Oral Daily 5 mg or 10 mg of Ulipristal Acetate (UPA)… (NCT01953679) | Clinical Trial Compass
CompletedPhase 2
Efficacy Study of Two Continuous Regimens of Oral Daily 5 mg or 10 mg of Ulipristal Acetate (UPA), Versus a Dose of 5.0mg UPA for 24/4 Days
United States180 participantsStarted 2014-03
Plain-language summary
To compare the pharmacodynamic effects of 2 continuous dose regimens of ulipristal acetate 5.0 and 10.0 mg-only oral contraception, versus a 24/4 day regimen of UPA 5.0 mg.
Who can participate
Age range18 Years – 35 Years
SexFEMALE
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Inclusion criteria
✓. Women between 18 and 35 years old.
✓. In good health, with regular menstrual cycles that occur every 21-35 days.
✓. If subject is postpartum or post-abortal (with abortion in second trimester), she will be required to have two normal menstrual cycles (3 menses) prior to screening.
✓. If subject had an abortion in the first trimester, she will be required to have at least one menstrual cycle (two menses) prior to screening.
✓. No current use of hormonal contraception or an intrauterine device and having had at least one complete menstrual cycle since having stopped hormonal contraception before starting the treatment.
✓. Have a negative urine pregnancy test at the admission visit.
✓. Will not be at risk for pregnancy. They will be consistently using a non-hormonal method, barrier method with every act of intercourse until the time of study exit OR have a surgically sterile male partner with a vasectomy, must have undergone previous tubal ligation, be abstinent, or be in a same-sex relationship from the control period through study exit (including recovery period).
✓. In the opinion of the investigator, willing and able to follow all study requirements, including use of the study product and willing to record requested information on a daily diary.
Exclusion criteria
✕. Women less than 18 and older than 35 years old.
✕. Women with menstrual cycle length of less than 21 or more than 35 days; or with spontaneous irregular menstrual cycle length with intra-individual variations of more than 5 days.
✕. Currently pregnant as confirmed by positive high-sensitivity urine pregnancy test.
✕. Unwilling to use a barrier method with every act of intercourse until study exit OR not have a surgically sterile male partner with a vasectomy, not have undergone previous tubal ligation, not abstinent, or not in a same-sex relationship from the control period through study exit (including recovery period).
✕. Women planning pregnancy within their months of study participation.
✕. Currently breast-feeding or within 30 days of discontinuing breast feeding, unless the woman has already had a menses following discontinuation of breast feeding.
✕. Current use of an IUD, or other hormonal contraception within last complete menstrual cycle prior to screening.