Levonorgestrel concentrations during 7 years of continuous use of Jadelle contraceptive implants
Sivin,Irving; Wan,Livia; Ranta,Sirpa; Alvarez,Francisco; Brache,Vivian; Mishell,Daniel R.,Jr.; Darney,Philip; Biswas,Arijit; Diaz,Soledad; Kiriwat,Orawan; Anant,Manee Piya; Klaisle,Cynthia; Pavez,Margarita; Schechter,Janet
Contraception 64(1): 43-49
Publication date: 2001
Serum levonorgestrel concentrations were assayed in a multicenter, 7-year study of 199 users of Jadelle rod implants. We examined drug levels, patterns of changes, factors affecting drug levels, and concentrations at which pregnancies occurred. Mean levonorgestrel concentrations declined from 435 pg/mL at 1 month of use to 64% of that value (280 pg/mL) at the end of 3 years. Between the end of the third and fifth years neither mean nor median serum levels varied markedly. At 5 years the mean concentration was again 64% of the first month's mean. Declining levels were observed thereafter through the end of 7 years when the mean, 224 pg/mL, was 52% of the 1-month value. Last measured drug concentrations of women who became pregnant during Jadelle use had mean and median values of 152 and 144 pg/mL, respectively, and a maximum value of 180 pg/mL. Analyses indicated ponderal index, body weight, duration of use, and a single clinical center were the most important variables affecting measured levonorgestrel levels. Approximately one-third of assays in the sixth and seventh years were found to be below 180 pg/mL, suggesting that Jadelle levonorgestrel implants would not maintain sufficiently high levels of effectiveness against pregnancy after 5 years and that heavier women would then be at greater risk of pregnancy.