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.

本研究评估了每4个月注射一次Sayana® Press、持续12个月（共3个治疗周期）的有效性、药代动力学（PK）、安全性与可接受性，而非当前处方信息推荐的每3个月注射一次。本研究共纳入750名年龄在18至35岁之间、月经周期规律且存在妊娠风险的健康性活跃女性，招募地点位于多米尼加共和国、巴西和智利的3家临床中心。第一队列纳入630名女性，按1:1比例随机分组，分别在腹部或大腿上部接受Sayana® Press注射；第二药代动力学队列包含120名女性，除妊娠检测外，她们同意在研究参与期间的6个时间点采血以检测醋酸甲羟孕酮（MPA），该队列按1:1:1比例随机分组，分别在腹部、大腿上部或上臂后部接受注射。按照Sayana® Press药品说明书的要求，在腹部或大腿上部接受注射的710名女性构成了评估避孕有效性的主要研究人群。本研究开展了分析以对比三种注射部位的药代动力学特征。本研究得以开展，得益于美国民众通过美国国际开发署（USAID）提供的慷慨资助，该资助通过合作协议AID-OAA-A-15-00045拨付给FHI 360。