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Obstetrics & Gynecology 2008;112:563-571
© 2008 by The American College of Obstetricians and Gynecologists
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ORIGINAL RESEARCH

Frequency and Management of Breakthrough Bleeding With Continuous Use of the Transvaginal Contraceptive Ring

A Randomized Controlled Trial

Patricia J. Sulak, MD, Virginia Smith, MD, Andrea Coffee, PharmD, Iris Witt, RN, Alicia L. Kuehl, BS and Thomas J. Kuehl, PhD

From the Department of Obstetrics and Gynecology, Scott and White Memorial Hospital and Clinic, Texas A&M Health Science Center College of Medicine, Temple, Texas.

OBJECTIVE: To assess bleeding patterns with continuous use of the transvaginal contraceptive ring.

METHODS: We did a prospective analysis of daily menstrual flow during a 21/7 cycle followed by 6 months of continuous use and institution of a randomized protocol to manage breakthrough bleeding/spotting. Seventy-four women completed the baseline 21/7 phase and were randomized equally into two groups during the continuous phase. Group 1 was instructed to replace the ring monthly on the same calendar day with no ring-free days. Group 2 was instructed to use the same process, but if breakthrough bleeding/spotting occurred for 5 days or more, they were to remove the ring for 4 days, store it, and then reinsert that ring.

RESULTS: Sixty-five women completed the continuous phase with reduced average flow scores in the continuous phase compared with the 21/7 phase (P<.02). Most patients had no to minimal bleeding during continuous use, with group 2 experiencing a statistically greater percentage of days without breakthrough bleeding or spotting (95%) compared with group 1 (89%) (P=.016). Instituting a 4-day hormone-free interval was more (P<.001) effective in resolving breakthrough bleeding/spotting than continuing ring use.

CONCLUSION: A reduction in bleeding occurred during continuous use with replacement of the transvaginal ring compared with baseline 21/7 use. Continuous vaginal ring use resulted in an acceptable bleeding profile in most patients, reduction in flow, reduction in pelvic pain, and a high continuation rate.

CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00475553

LEVEL OF EVIDENCE: I




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JWatch Women's HealthHome page
Menstrual Bleeding Patterns Associated with Continuous Use of the Contraceptive Ring
Journal Watch Women's Health, October 16, 2008; 2008(1016): 4 - 4.
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