Sino-implant (II) — a levonorgestrel-releasing two-rod implant: systematic review of the randomized controlled trials☆☆☆
Received 20 August 2009; received in revised form 30 October 2009; accepted 30 October 2009. published online 07 December 2009.
Abstract
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.
Study Design
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.
☆ FHI is the recipient of grant funding to provide quality testing of Sino-Implant (II) independent of Shanghai Dahua Pharmaceuticals' own QA/QC tests [1], to assist Dahua in identifying distribution partners and to provide technical assistance to distributors in the registration and introduction of the product. Distributors of the product provide a preferential price to the public sector. Dr. Steiner is part of a consulting firm facilitating regulatory approval and product testing of other reproductive health products. Dr. Grimes has consulted with Bayer Healthcare Pharmaceuticals and Schering-Plough, two manufacturers of contraceptive implants.
☆☆ Support for this research was provided by the Bill & Melinda Gates Foundation. The views expressed in this publication do not necessarily reflect those of FHI, the World Health Organization or the funding agency.
ABSTRACT