Randomized trial to evaluate contraceptive efficacy, safety and acceptability of a two rod contraceptive implant over four years in the Dominican Republic

Abstract Objective Sino-implant (II) is a contraceptive implant that had a commodity price one-third of the competing products a decade ago. To make Sino-implant (II) more widely available, we conducted a trial to collect safety and efficacy data required for WHO prequalification, a quality standard allowing global donors to procure a pharmaceutical product. Study design This was a randomized controlled trial allocating 650 participants to either Sino-implant (II) or Jadelle®. Participants were seen at one and six months, and then semi-annually. The primary efficacy measure was the pregnancy Pearl Index (number of pregnancies per 100 women-years of follow-up) in the Sino-implant (II) group during up to four years of implant use. Results For the primary outcome, Sino-implant (II) had a four-year Pearl Index of 0.74 (95% CI: 0.36–1.37), compared to 0.00 (95% CI: 0.00–1.04) for Jadelle®. The Sino-implant (II) pregnancy rate was significantly higher in the fourth year (3.54 per 100 WY) than in the first three years combined (0.18 per 100 WY; p  Conclusion Based on these results, WHO pre-qualified Sino-Implant (II) with a three-year use label in June 2017; two years shorter than the 5-year duration of Jadelle®. Implications. WHO prequalification allows global donors to procure Sino-implant (II), which means women in many low resource countries will have greater access to highly effective and acceptable contraceptive implants. Our study noted important clinical differences, including shorter duration of high effectiveness with Sino-implant (II) when compared to the other available two-rod system, Jadelle®. Introduction strategies should include appropriate training on these differences.