significantly reduced the pregnancy rate, from an expected 5.6% to an observed 1.9%, when taken within 72 hours after unprotected intercourse (p=0.001). There were no pregnancies observed in the women who were administered EllaOne more than 72 hours after unprotected intercourse (10% of women who received EllaOne). ii) Open-Label Study This study was a multi-centre open-label designed to support the efficacy and safety of ulipristal acetate for emergency contraception when taken 48 to 120 hours after unprotected intercourse. Main inclusion criteria were women, 18 or greater years of age, with regular cycle length (24 to 35 days) presenting for emergency contraception between 48 hours and 120 hours of unprotected intercourse. In total, 1,533 healthy women with a mean age of 24 years received a dose of 30 mg ulipristal acetate (EllaOne). The primary efficacy measurement was the pregnancy rate, calculated as the number of pregnancies after administration of emergency contraception, divided by the number of subjects administered emergency contraception. Twenty-seven pregnancies occurred in 1,242 women aged 18 to 35 years evaluated for efficacy for a pregnancy rate of 2.1%. The number of pregnancies expected without emergency contraception was calculated based on the timing of intercourse with regard to each woman’s menstrual cycle. EllaOne significantly reduced the pregnancy rate, from an expected rate of 5.5% to an observed rate of 2.2%, when taken 48 to 120 hours after unprotected intercourse (p<0.001). iii) Phase II Comparative Study Study HRA2914-507 was a randomized double-blind study conducted in healthy cycling women at least 18 years old and who requested emergency contraception at one of the participating clinical sites in the US within 72 hours (3 days) of unprotected intercourse. It was designed as a non-inferiority to test the following hypothesis that 50 mg unmicronized ulipristal acetate had a pregnancy rate no worse than that of levonorgestrel with a non-inferiority margin of 2%. The efficacy evaluable (EE) population included 1,546 women (773 the ulipristal acetate group and 773 in the levonorgestrel group).
significantly reduced the pregnancy rate, from an expected 5.6% to an observed 1.9%, when taken within 72 hours after unprotected intercourse (p=0.001). There were no pregnancies observed in the women who were administered EllaOne more than 72 hours after unprotected intercourse (10% of women who received EllaOne). ii) Open-Label Study This study was a multi-centre open-label designed to support the efficacy and safety of ulipristal acetate for emergency contraception when taken 48 to 120 hours after unprotected intercourse. Main inclusion criteria were women, 18 or greater years of age, with regular cycle length (24 to 35 days) presenting for emergency contraception between 48 hours and 120 hours of unprotected intercourse. In total, 1,533 healthy women with a mean age of 24 years received a dose of 30 mg ulipristal acetate (EllaOne). The primary efficacy measurement was the pregnancy rate, calculated as the number of pregnancies after administration of emergency contraception, divided by the number of subjects administered emergency contraception. Twenty-seven pregnancies occurred in 1,242 women aged 18 to 35 years evaluated for efficacy for a pregnancy rate of 2.1%. The number of pregnancies expected without emergency contraception was calculated based on the timing of intercourse with regard to each woman’s menstrual cycle. EllaOne significantly reduced the pregnancy rate, from an expected rate of 5.5% to an observed rate of 2.2%, when taken 48 to 120 hours after unprotected intercourse (p<0.001). iii) Phase II Comparative Study Study HRA2914-507 was a randomized double-blind study conducted in healthy cycling women at least 18 years old and who requested emergency contraception at one of the participating clinical sites in the US within 72 hours (3 days) of unprotected intercourse. It was designed as a non-inferiority to test the following hypothesis that 50 mg unmicronized ulipristal acetate had a pregnancy rate no worse than that of levonorgestrel with a non-inferiority margin of 2%. The efficacy evaluable (EE) population included 1,546 women (773 the ulipristal acetate group and 773 in the levonorgestrel group).
auspar-ulipristal-acetate-150904-pi.docx