A multicentre efficacy and safety study of the single contraceptive implant Implanon (R)

An open, multicentre study was performed to assess efficacy, safety and acc eptability of the single-rod contraceptive implant Implanon((R)). The study involved 635 young healthy women, who were sexually active and of childbea ring potential, The women were followed up every 3 months over the entire s tudy period. Originally the study was designed for 2 years, but was extende d to 3 years in a group of 147 women from two centres. Altogether, 21 centr es in nine different countries participated, The average age of the women w as 29 years (range 18-42 years), of whom 83.5% had been pregnant in the pas t. No pregnancy occurred during treatment with Implanon((R)), resulting in a Pearl Index of 0 (95% confidence interval: 0.0-0.2). In the first 2 years , 31% had discontinued the treatment. Of the 147 women in the study extensi on, nine discontinued (6%) treatment, Bleeding irregularities was the main reason for discontinuation during the first 2 years of use (17.2%) and adve rse experiences in the third year (3.4%), Implant insertion and removal wer e fast and uncomplicated in the vast majority (97%) of cases. Return of fer tility was prompt. In conclusion, Implanon((R)) has excellent contraceptive action during its lifetime of 3 years, The safety profile is acceptable an d not essentially different from progestogens in general.