Sino-implant (II)--a levonorgestrel-releasing two-rod implant: systematic review of the randomized controlled trials.
BACKGROUND
Sino-implant (II) is a subdermal contraceptive implant manufactured in China. This two-rod levonorgestrel-releasing implant has the same amount of active ingredient (150 mg levonorgestrel) and mechanism of action as the widely available contraceptive implant Jadelle. We examined randomized controlled trials of Sino-implant (II) for effectiveness and side effects.


METHODS
We searched electronic databases for studies of Sino-implant (II) and then restricted our review to randomized controlled trials. The primary outcome of this review was pregnancy.


RESULTS
Four randomized trials with a total of 15,943 women assigned to Sino-implant (II) had first-year probabilities of pregnancy ranging from 0.0% to 0.1%. Cumulative probabilities of pregnancy during the 4 years of the product's approved duration of use were 0.9% and 1.06% in the two trials that presented date for 4-year use. Five-year cumulative probabilities of pregnancy ranged from 0.7% to 2.1%. In one trial, the cumulative probability of pregnancy more than doubled during the fifth year (from 0.9% to 2.1%), which may be why the implant is approved for 4 years of use in China. Five-year cumulative probabilities of discontinuation due to menstrual problems ranged from 12.5% to 15.5% for Sino-implant (II).


CONCLUSIONS
Sino-implant (II) is one of the most effective contraceptives available today. These available clinical data, combined with independent laboratory testing, and the knowledge that 7 million women have used this method since 1994, support the safety and effectiveness of Sino-implant (II). The lower cost of Sino-implant (II) compared with other subdermal implants could improve access to implants in resource-constrained settings.
Family Health International, Research Triangle Park, NC 27709, USA. msteiner@fhi.org
Markus J
MJ
Steiner
Laureen M
LM
Lopez
David A
DA
Grimes
Linan
L
Cheng
Jim
J
Shelton
James
J
Trussell
Timothy M M
TM
Farley
Laneta
L
Dorflinger
D003271:Contraceptive Agents, Female / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D016912:Levonorgestrel / Q000008:administration & dosage*; D017060:Patient Satisfaction; D011247:Pregnancy; D019736:Prostheses and Implants; D016032:Randomized Controlled Trials as Topic
D003271:Contraceptive Agents, Female; D016912:Levonorgestrel