Obstetrics and gynecology · 2008
Multicenter comparison of the contraceptive ring and patch: a randomized controlled trial.
СтатьяМногоцентровое исследованиеРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Creinin Mitchell D, Meyn Leslie A, Borgatta Lynn, Barnhart Kurt, Jensen Jeff, Burke Anne E, Westhoff Carolyn, Gilliam Melissa, Dutton Caryn, Ballagh Susan A
Аннотация
OBJECTIVE: To understand if the contraceptive ring or patch was more acceptable, as measured primarily by continuation, to women using an oral contraceptive and interested in a nondaily, combined hormonal contraceptive.
METHODS: Five hundred women were randomly assigned to use the contraceptive ring (n=249) or contraceptive patch (n=251) for four consecutive menstrual cycles, starting with their next menses. Participants returned for a single follow-up visit during the fourth cycle for an evaluation, which included a questionnaire to assess acceptability and adverse effects.
RESULTS: Rates of completion of three cycles were 94.6% (95% confidence interval [CI] 91.0-97.1%) and 88.2% (95% CI 83.4-92.0%) for ring and patch users, respectively (P=.03). Of these women, 71.0% (95% CI 64.8-76.6%) and 26.5% (95% CI 21.0-32.6%), respectively, planned to continue their method after the study (P<.001). Women switching to the patch were significantly more likely than women switching to the ring to experience longer periods (38% compared with 9%), increased dysmenorrhea (29% compared with 16%), frequent nausea (8% compared with 1%), frequent mood swings (14% compared with 8%), and frequent skin rash (12% compared with 2%) and were less likely to experience frequent vaginal discharge (8% compared with 17%). Ring users preferred the ring to the oral contraceptive (P<.001), and patch users preferred the oral contraceptive to the patch (P<.001). Nugent scores increased only in patch users (P=.01), although most of these women were asymptomatic.
CONCLUSION: Women satisfied with combined oral contraceptives and interested in a nondaily method are more likely to continue using the contraceptive ring than the contraceptive patch.
CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00269620.
LEVEL OF EVIDENCE: I.
METHODS: Five hundred women were randomly assigned to use the contraceptive ring (n=249) or contraceptive patch (n=251) for four consecutive menstrual cycles, starting with their next menses. Participants returned for a single follow-up visit during the fourth cycle for an evaluation, which included a questionnaire to assess acceptability and adverse effects.
RESULTS: Rates of completion of three cycles were 94.6% (95% confidence interval [CI] 91.0-97.1%) and 88.2% (95% CI 83.4-92.0%) for ring and patch users, respectively (P=.03). Of these women, 71.0% (95% CI 64.8-76.6%) and 26.5% (95% CI 21.0-32.6%), respectively, planned to continue their method after the study (P<.001). Women switching to the patch were significantly more likely than women switching to the ring to experience longer periods (38% compared with 9%), increased dysmenorrhea (29% compared with 16%), frequent nausea (8% compared with 1%), frequent mood swings (14% compared with 8%), and frequent skin rash (12% compared with 2%) and were less likely to experience frequent vaginal discharge (8% compared with 17%). Ring users preferred the ring to the oral contraceptive (P<.001), and patch users preferred the oral contraceptive to the patch (P<.001). Nugent scores increased only in patch users (P=.01), although most of these women were asymptomatic.
CONCLUSION: Women satisfied with combined oral contraceptives and interested in a nondaily method are more likely to continue using the contraceptive ring than the contraceptive patch.
CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00269620.
LEVEL OF EVIDENCE: I.