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. Copyright (c) 2010 Elsevier Inc. All rights reserved.
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. Copyright (c) 2010 Elsevier Inc. All rights reserved.
Authors: Rena C Patel; Beatrice Jakait; Katherine Thomas; Constantin Yiannoutsos; Maricianah Onono; Elizabeth A Bukusi; Kara K Wools-Kaloustian; Craig R Cohen Journal: Contraception Date: 2019-06-24 Impact factor: 3.375
Authors: Ramla F Tanko; Rubina Bunjun; Smritee Dabee; Shameem Z Jaumdally; Maricianah Onono; Gonasagrie Nair; Thesla Palanee-Phillips; Rushil Harryparsad; Anna Ursula Happel; Hoyam Gamieldien; Yamkela Qumbelo; Musalula Sinkala; Caitlin W Scoville; Kate Heller; Jared M Baeten; Steven E Bosinger; Adam Burgener; Renee Heffron; Heather B Jaspan; Jo Ann S Passmore Journal: J Infect Dis Date: 2022-09-13 Impact factor: 7.759
Authors: Rena C Patel; Chelsea Morroni; Kimberly K Scarsi; Tabitha Sripipatana; James Kiarie; Craig R Cohen Journal: J Int AIDS Soc Date: 2017-05-11 Impact factor: 5.396
Authors: Y Che; D Taylor; D Luo; L Y Maldonado; M Wang; S Wevill; H Vahdat; X Han; V Halpern; L Dorflinger; M J Steiner Journal: Contracept X Date: 2019
Authors: Rena C Patel; Maricianah Onono; Monica Gandhi; Cinthia Blat; Jill Hagey; Starley B Shade; Eric Vittinghoff; Elizabeth A Bukusi; Sara J Newmann; Craig R Cohen Journal: Lancet HIV Date: 2015-10-22 Impact factor: 12.767
Authors: Jeannine Mukamuyango; Rosine Ingabire; Rachel Parker; Julien Nyombayire; Andrew Abaasa; Gershim Asiki; Sarah Rae Easter; Kristin M Wall; Laetitia Nyirazinyoye; Amanda Tichacek; Nadine Kaslow; Matt A Price; Susan Allen; Etienne Karita Journal: Reprod Health Date: 2020-08-17 Impact factor: 3.223