Nexplanon, a radiopaque etonogestrel implant in combination with a next-generation applicator: 3-year results of a noncomparative multicenter trial - 30/10/12
Résumé |
Objective |
To investigate the efficacy, safety, removal characteristics, and x-ray visibility of Nexplanon, a radiopaque etonogestrel contraceptive implant combined with a next-generation applicator.
Study Design |
A 3-year, nocomparative, multicenter study in women aged 18–40 years at 23 clinical sites.
Results |
Of 301 women who had an implant inserted, none became pregnant while the implant was in situ. Serious adverse events were reported in 16 of 301 (5.3%) women; none were judged as drug related. Fibrosis around the implant was the most common removal complication (4.4%). The implant was visible on X-ray and palpable before removal with a mean removal time of 2 minutes.
Conclusion |
Nexplanon showed high contraceptive efficacy, palpability before removal, short removal times, and few removal complications. Nexplanon provides clinicians with a long-term hormonal contraceptive method with a safety and efficacy profile comparable to Implanon, radiopacity, and a new applicator.
Le texte complet de cet article est disponible en PDF.Key words : contraceptive implant, etonogestrel, long-acting reversible contraceptive, Nexplanon
Plan
| Merck, Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., provided financial support to the conduct of the study. |
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| E.M. is now an employee of Synthon, Nijmegen, the Netherlands. Principal investigators are listed in the Acknowledgments. |
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| G-F.B., T.G.G., K.P.P., and T.S.S. were contracted by Merck to carry out this study. E.M. was an employee of MSD, a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ, at the time the study was conducted. M.M-P. is an employee of MSD. E.M. and M.M-P. may own stock and/or hold stock options in the company. |
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| www.clinicaltrials.gov identifier: NCT00620035. |
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| Reprints are not available from the authors. |
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| Cite this article as: Mommers E, Blum G-F, Gent TG, et al. Nexplanon, a radiopaque etonogestrel implant in combination with a next-generation applicator: 3-year results of a noncomparative multicenter trial. Am J Obstet Gynecol 2012;207:388.e1-6. |
Vol 207 - N° 5
P. 388.e1-388.e6 - novembre 2012 Retour au numéro
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