title: Safety and efficacy of the NuvaRing® Applicator in healthy females: a multicenter, open-label, randomized, 2-period crossover study.
abstract: We assessed performance and safety of the NuvaRing® Applicator.
  
  
  
  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.
  
  
  
  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).
  
  
  
  NuvaRing Applicator is effective and well-tolerated (NCT02275546).
authors.affiliation: Miami Research Associates, LLC, Miami, FL, USA.
authors.forename: Robert
authors.initials: R
authors.lastname: Feldman
authors.affiliation: Merck Research Laboratories, Merck Sharp & Dohme Corp., Kenilworth, NJ, USA.
authors.forename: Tara L
authors.initials: TL
authors.lastname: Frenkl
authors.affiliation: Merck Research Laboratories, Merck Sharp & Dohme Corp., Kenilworth, NJ, USA.
authors.forename: Carol
authors.initials: C
authors.lastname: Yacik
authors.affiliation: Merck Research Laboratories, Merck Sharp & Dohme Corp., Kenilworth, NJ, USA.
authors.forename: Yinna
authors.initials: Y
authors.lastname: Wang
authors.affiliation: Merck Research Laboratories, Merck Sharp & Dohme Corp., Kenilworth, NJ, USA. Electronic address: michelle.fox2@merck.com.
authors.forename: Michelle C
authors.initials: MC
authors.lastname: Fox
mesh_terms: D000293:Adolescent; D000328:Adult; D003274:Contraceptive Devices, Female; D018592:Cross-Over Studies; D017135:Desogestrel / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D004338:Drug Combinations; D004997:Ethinyl Estradiol / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D005385:Fingers; D006801:Humans; D008875:Middle Aged; D011795:Surveys and Questionnaires; D014621:Vagina; D055815:Young Adult
chemical_list: D004338:Drug Combinations; C516519:NuvaRing; D004997:Ethinyl Estradiol; D017135:Desogestrel
keywords: Applicator; Contraceptive vaginal ring; Ethinyl estradiol; Etonogestrel; Intravaginal