Study to Evaluate the Effectiveness, Pharmacokinetics, Safety, and Acceptability of Sayana® Press when Injected Every Four Months (FHI 360 2017-2020)

This study evaluated the effectiveness, PK, safety, and acceptability of Sayana® Press when injected every 4 months for 12 months (3 treatment cycles), rather than every 3 months per current prescribing information. A total of 750 healthy, sexually active women aged 18 to 35 years with regular menstrual cycles and at risk of pregnancy were enrolled at 3 sites in the Dominican Republic, Brazil, and Chile. One cohort of N=630 women was randomized 1:1 to receive injections of Sayana® Press in the abdomen or upper thigh, and a second PK cohort of N=120 women who, in addition to pregnancy testing, agreed to blood draws for MPA testing at 6 time points during their study participation, was randomized 1:1:1 to receive injections in the abdomen, upper thigh, or back of the upper arm. The N=710 women receiving injections in the abdomen or thigh, per Sayana® Press package insert instructions, constituted the primary population for assessing contraceptive efficacy. Analyses were done to compare PK across the three injection sites. This study was made possible through the generous support of the American people through the U.S. Agency for International Development (USAID), provided to FHI 360 through Cooperative Agreement AID-OAA-A-15-00045.