Original article| Volume 99, ISSUE 6, P340-344, June 2019

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Bleeding and spotting with the levonorgestrel 13.5 mg intrauterine system: the impact of insertion timing



      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.


      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).


      Early cycle insertion does not impact 90-day bleeding/spotting. Early cycle insertion and recent hormonal contraceptive use decrease 30-day bleeding.


      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.


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        • Apter D.
        • Ph D.
        • Briggs P.
        • Ch M.B.B.
        • Tuppurainen M.
        • Grunert J.
        • et al.
        Study comparing the levonorgestrel intrauterine system with the etonogestrel subdermal implant.
        Fertil Steril. 2016; 106: 151-157
        • Gemzell-Danielsson K.
        • Schellschmidt I.
        • Apter D.
        A randomized, phase II study describing the efficacy, bleeding profile, and safety of two low-dose levonorgestrel-releasing intrauterine contraceptive systems and Mirena.
        Fertil Steril. 2012; 97: 616-622
        • Grunloh D.S.
        • Casner T.
        • Secura G.M.
        • Peipert J.F.
        • Madden T.
        Characteristics associated with discontinuation of long-acting reversible contraception within the first 6 months of use.
        Obstet Gynecol. 2013; 122: 1214-1221
        • Nelson A.
        • Apter D.
        • Hauck B.
        • Schmelter T.
        • Rybowski S.
        • Rosen K.
        • et al.
        Two low-dose levonorgestrel intrauterine contraceptive systems: a randomized controlled trial.
        Obstet Gynecol. 2013; 122: 1205-1213
        • Eisenberg D.L.
        • Schreiber C.A.
        • Turok D.K.
        • Teal S.B.
        • Westhoff C.L.
        • Creinin M.D.
        Three-year efficacy and safety of a new 52 mg levonorgestrel-releasing intrauterine system.
        Contraception. 2015; 92: 10-16
        • Fan G.
        • Kang S.
        • Ren M.
        • Weisberg E.
        • Lukkari-Lax E.
        • Roth K.
        • et al.
        A single-arm phase III study exploring the efficacy and safety of LNG-IUS 8, a low-dose levonorgestrel intrauterine contraceptive system (total content 13.5 mg), in an Asia-Pacific population.
        Contraception. 2017; 95: 371-377
        • Langer J.E.
        26 — Normal anatomy of the female pelvis and transvaginal sonography.
        6th ed. Elsevier Inc, 2016
        • Belsey E.
        • Machin D.
        • D'Arcangues C.
        The analysis of vaginal bleeding patterns induced by fertility regulating methods.
        Contraception. 1986; 34: 253-260
        • Jones R.L.
        • Critchley H.
        Morphological and functional changes in human endometrium following intrauterine levonorgestrel delivery.
        Hum Reprod. 2000; 15: 162-172
        • Gemzell-Danielsson K.
        • Inki P.
        • Boubli L.
        • O'Flynn M.
        • Kunz M.
        • Heikinheimo O.
        Bleeding pattern and safety of consecutive use of the levonorgestrel-releasing intrauterine system (LNG-IUS) — a multicentre prospective study.
        Hum Reprod. 2010; 25: 354-359
        • Schreiber C.A.
        • Teal S.B.
        • Blumenthal P.D.
        • Keder L.M.
        • Olariu A.I.
        • Creinin M.D.
        • et al.
        Bleeding patterns for the Liletta levonorgestrel 52 mg intrauterine system.
        Eur J Contracept Reprod Heal Care. 2018; 23: 116-120