Safety and efficacy of the NuvaRing® Applicator in healthy females: a multicenter, open-label, randomized, 2-period crossover study

Contraception. 2016 Oct;94(4):362-5. doi: 10.1016/j.contraception.2016.04.017. Epub 2016 May 17.

Abstract

Introduction: We assessed performance and safety of the NuvaRing® Applicator.

Methods: We randomized women (18-45 years) to insert a placebo ring using the applicator or fingers-only and then vice versa. We assessed outcomes post-insertion and then 24-72 h later.

Results: Insertion was 100% successful using both methods (applicator, n=163; fingers-only, n=162). A total of 8.6% (applicator) and 4.3% (fingers-only) of subjects reported at least 1 treatment-related adverse event (AE); all were mild. Subjects reported 5 applicator-related AEs (vulvovaginal pain, 4; abdominal cramping, 1). There was no vaginal bleeding within 15 h post-applicator use. Ring expulsions were rare (applicator, 1; fingers-only, 2).

Conclusion: NuvaRing Applicator is effective and well-tolerated (NCT02275546).

Keywords: Applicator; Contraceptive vaginal ring; Ethinyl estradiol; Etonogestrel; Intravaginal.

Publication types

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

MeSH terms

  • Adolescent
  • Adult
  • Contraceptive Devices, Female*
  • Cross-Over Studies
  • Desogestrel / administration & dosage
  • Desogestrel / adverse effects
  • Desogestrel / analogs & derivatives*
  • Drug Combinations
  • Ethinyl Estradiol / administration & dosage*
  • Ethinyl Estradiol / adverse effects
  • Female
  • Fingers
  • Humans
  • Middle Aged
  • Surveys and Questionnaires
  • Vagina
  • Young Adult

Substances

  • Drug Combinations
  • NuvaRing
  • Ethinyl Estradiol
  • Desogestrel

Associated data

  • ClinicalTrials.gov/NCT02275546