Abstract
Objective
To assess the impact of early versus late menstrual cycle insertion on bleeding/spotting
in the 90 days following levonorgestrel (LNG) 13.5 mg intrauterine system (IUS) insertion.
Study design
In this observational study, participants received a LNG 13.5 mg IUS and provided
90 days of bleeding/spotting data by answering the following daily text: “Have you
had no flow (0), spotting (1), or bleeding (2) today?” We dichotomized insertion timing
as early (days 1–7 from last menstrual period) and late (remainder of menstrual cycle)
and compared bleeding/spotting between the two groups in the 90- and 30-day reference
periods. We used multivariate regression methods to study associations between cycle
day at insertion, parity, historical bleeding, recent hormonal contraceptive use and
bleeding/spotting.
Results
In the 90-day dichotomous analysis (n=125), we found no differences in the number of days of bleeding/spotting, bleeding
or spotting between the early and late insertion groups. In the 30-day dichotomous
analysis (n=131), early insertion was associated with fewer days of bleeding than late insertion
(5±3 vs. 7±4 days, p<.01). Recent hormonal contraceptive users experienced fewer days
of bleeding than new users (5±4 vs. 7±3 days, p<.01). In the 90- and 30-day regression
models, earlier insertion was associated with fewer days of bleeding (p=.02, p=.02).
Recent contraceptive use was associated with fewer days of bleeding/spotting (90-day,
p=.03) and fewer days of bleeding (30-day, p<.01). Nulliparity was associated with
spotting (30-day, p=.04).
Conclusions
Early cycle insertion does not impact 90-day bleeding/spotting. Early cycle insertion
and recent hormonal contraceptive use decrease 30-day bleeding.
Implications
The LNG 13.5 mg IUS may be inserted throughout the menstrual cycle with small differences
in bleeding patterns in the 30 but not the 90 days following insertion. Shared decision
making should determine timing of insertion.
Keywords
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Article info
Publication history
Published online: March 01, 2019
Accepted:
February 6,
2019
Received in revised form:
February 1,
2019
Received:
October 19,
2018
Footnotes
☆Funding sources: This work was supported by Bayer HealthCare Pharmaceuticals, Whippany, NJ, USA. Bayer was not involved in study design, data collection, analysis, interpretation of data, writing of the report or the decision to submit the article for publication.
☆☆Dr. Shimoni served as a consultant for Bayer's IUD Expansion Advisory Board.
★Clinical trial registration: NCT03074903
Identification
Copyright
© 2019 Elsevier Inc. All rights reserved.
