4.3 Article

Contraceptive vaginal ring treatment of heavy menstrual bleeding: a randomized controlled trial with norethisterone

Journal

CONTRACEPTION
Volume 85, Issue 3, Pages 246-252

Publisher

ELSEVIER SCIENCE INC
DOI: 10.1016/j.contraception.2011.07.012

Keywords

Menorrhagia; Heavy menstrual bleeding; Vaginal ring; Norethisterone acetate

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Background: This study compared the efficacy of the contraceptive vaginal ring (CVR; NuvaRing; N.V. Organon, Oss, the Netherlands) and norethisterone for treatment of idiopathic heavy menstrual bleeding (HMB) during the fertile age. Study Design: Ninety-five women with idiopathic HMB were selected in this randomized controlled trial. They were treated with either the CVR (n=48) or norethisterone (n=47) for three cycles. Each cycle consisted of 3 weeks of CVR use and then a 1-week ring-free period or norethisterone tablets, 5 mg three times daily from Cycle Days 5 to 26. Outcome measures were as follows: menstrual blood loss assessed by pictorial blood loss assessment chart (PBAC), duration of menses, hemoglobin, serum ferritin, quality of life (QoL) questionnaire, side effects and overall satisfaction with treatment. Result: Significant improvements in PBAC score, the duration of menses, hemoglobin, serum ferritin and QoL were observed at the end of the study in each group. No statistically significant differences were found regarding the mean PBAC score (90.2 +/- 24.4 vs. 92.3 +/- 26.7) and its percent reduction (68.6% vs. 69.5%), duration of menses (5.3 +/- 1.2 vs. 5.5 +/- 1.1 days), hemoglobin and serum ferritin at the end of the study between the CVR and the norethisterone groups, respectively. Significantly more ring users were satisfied and elected to continue with treatment. Conclusion: Both the CVR and oral norethisterone are effective treatments for idiopathic HMB. The CVR may be an attractive option especially for those requesting contraception as well. (c) 2012 Elsevier Inc. All rights reserved.

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