This Sino-implant (II) pivotal clinical trial in the Dominican Republic collected safety and efficacy data for World Health Organization (WHO) prequalification, a quality standard allowing global donors to procure a pharmaceutical product. Based on data from this trial, WHO prequalified Sino-implant (II), marketed globally as Levoplant, as a three-year contraceptive method in June 2017, resulting in the distribution of more than one million units in the following year.
Randomized trial to evaluate contraceptive efficacy, safety and acceptability of a two-rod contraceptive implant over 4 years in the Dominican Republic
Written By
Steiner MJ, Brache V, Taylor D, Callahan R, Halpern V, Jorge A, Wevill S, Sergison J, Venkatasubramanian L, Dorflinger L
