Journal
CONTRACEPTION
Volume 94, Issue 4, Pages 362-365Publisher
ELSEVIER SCIENCE INC
DOI: 10.1016/j.contraception.2016.04.017
Keywords
Applicator; Contraceptive vaginal ring; Ethinyl estradiol; Etonogestrel; Intravaginal
Categories
Funding
- Merck & Co. Inc., Kenilworth, NJ, USA
- Merck
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Introduction: We assessed performance and safety of the NuvaRing (R) 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). (C) 2016 Elsevier Inc. All rights reserved.
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