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 Nov;207(5):388.e1-6. doi: 10.1016/j.ajog.2012.08.002. Epub 2012 Aug 10.

Abstract

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.

Trial registration: ClinicalTrials.gov NCT00620035.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Intravaginal
  • Adolescent
  • Adult
  • Contraceptive Agents, Female / administration & dosage*
  • Contraceptive Agents, Female / adverse effects
  • Contrast Media / administration & dosage
  • Contrast Media / adverse effects
  • Desogestrel / administration & dosage*
  • Desogestrel / adverse effects
  • Female
  • Fibrosis
  • Humans
  • Infusion Pumps, Implantable / adverse effects*
  • Uterus / drug effects
  • Uterus / pathology
  • Young Adult

Substances

  • Contraceptive Agents, Female
  • Contrast Media
  • etonogestrel
  • Desogestrel

Associated data

  • ClinicalTrials.gov/NCT00620035