Safety and efficacy of the NuvaRing® Applicator in healthy females: a multicenter, open-label, randomized, 2-period crossover study.
Contraception
; 94(4): 362-5, 2016 10.
Article
in En
| MEDLINE
| ID: mdl-27207028
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).Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Desogestrel
/
Contraceptive Devices, Female
/
Ethinyl Estradiol
Type of study:
Clinical_trials
Limits:
Adolescent
/
Adult
/
Female
/
Humans
/
Middle aged
Language:
En
Journal:
Contraception
Year:
2016
Type:
Article
Affiliation country:
United States