Management of Initial Bleeding or Spotting After... : Obstetrics & Gynecology (original) (raw)
Original Research
Management of Initial Bleeding or Spotting After Levonorgestrel-Releasing Intrauterine System Placement
A Randomized Controlled Trial
Sørdal, Terje MD; Inki, Pirjo MD, PhD; Draeby, John MD; O’Flynn, Mary MB; Schmelter, Thomas PhD
Medicus AS, Trondheim, Norway; Global Medical Affairs Women’s HealthCare and Global Clinical Statistics, Bayer Healthcare, Berlin, Germany; Gynecology, Skt Anne Plads, Odense, Denmark; and Town Centre Medical Practice, Cork, Ireland.
Corresponding author: Terje Sørdal, MD, Medicus AS, Sverres gate 15 E, Trondheim, 7012 Norway; e-mail: [email protected].
Funded by Bayer Healthcare, Berlin, Germany.
Financial Disclosure Dr. Sørdal is an employee of Medicus AS, who received financial support from Bayer HealthCare to conduct this clinical trial. Dr. Draeby and Ms. O’Flynn received financial support from Bayer HealthCare to conduct this clinical trial. Drs. Inki and Schmelter are employees of Bayer Healthcare.
The authors thank Karin Burock (BIOP, Basel, Switzerland) for additional statistical support and Luana Atherly-Henderson and Richard Glover of inScience Communications, Springer Healthcare, for medical writing support, funded by Bayer Healthcare.
OBJECTIVE:
To assess the efficacy of tranexamic acid or mefenamic acid in the management of the initial “nuisance” bleeding or spotting in the period immediately after placement of the levonorgestrel-releasing intrauterine system.
METHODS:
Women were randomized after levonorgestrel-releasing intrauterine system placement to oral tranexamic acid (500 mg), mefenamic acid (500 mg), or placebo three times daily during bleeding or spotting episodes over a 90-day treatment period. Treatment was initiated from onset of a bleeding or spotting episode and continued until the first day after bleeding or spotting stopped and restarted with a new bleeding or spotting episode. The primary efficacy variable was reduction in the number of bleeding or spotting days. Tranexamic acid and mefenamic acid were compared with placebo using a one-sided Wilcoxon rank-sum test. Bonferroni-Holm adjustment was used to account for multiple testing.
RESULTS:
A total of 204 women were screened; 187 were randomized to tranexamic acid (n=63), mefenamic acid (n=63), or placebo (n=61). The median number of bleeding or spotting days experienced during treatment was 25, 29, and 33 days in the three groups, respectively. The median number of bleeding or spotting days was reduced by 6 days (95% confidence interval [CI] –14.0 to 1.0, _P_=.049) with tranexamic acid and by 3 days (95% CI –11.0 to 5.0, _P_=.229) with mefenamic acid compared with placebo. The relative risk of bleeding or spotting compared with placebo with tranexamic acid and mefenamic acid was 0.82 (95% CI 0.65–1.03) and 0.89 (95% CI 0.71–1.11), respectively. Most women (85% or more) were satisfied with the levonorgestrel-releasing intrauterine system across the groups.
CONCLUSIONS:
Tranexamic acid and mefenamic acid during the first 90 days after levonorgestrel-releasing intrauterine system placement do not alleviate “nuisance” bleeding or spotting.
CLINICAL TRIAL REGISTRATION:
ClinicalTrials.gov, www.clinicaltrials.gov, NCT01295294.
LEVEL OF EVIDENCE:
I
© 2013 by The American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.