Evaluation of a new, low-dose levonorgestrel intrauterine contraceptive system over 5 years of use

Gemzell‐Danielsson, Kristina; Apter, Dan; Dermout, Sylvia; Faustmann, Thomas; Rosen, K.; Schmelter, Thomas; Merz, Martin; Nelson, Anita L.

doi:10.1016/j.ejogrb.2016.11.022

Cited by 53 publications

(60 citation statements)

References 12 publications

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“…The 1-year amenorrhea rates with a LNG 52 mg IUS are notably higher than those reported with lower-dose LNG IUS products. The amenorrhea rates at 1 year with products containing 13.5 mg and 19.5 mg of LNG are 6% and 12.7%, respectively [14,15]. It is unclear whether or not some women enrolled in these studies recently used a LNG IUS.…”

Section: Discussionmentioning

confidence: 99%

Amenorrhea rates and predictors during 1 year of levonorgestrel 52 mg intrauterine system use

et al. 2018

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Objective: The objective was to evaluate amenorrhea patterns and predictors of amenorrhea during the first year after levonorgestrel 52 mg intrauterine system (IUS) placement. Study design: This cohort analysis includes 1714 nulliparous and parous women who received a Liletta® levonorgestrel 52 mg IUS in a multicenter trial to evaluate efficacy and safety for up to 8 years. Participants maintained a daily diary with bleeding information. We assessed bleeding patterns in 90-day intervals; amenorrhea was defined as no bleeding or spotting in the preceding 90 days. We employed multivariable regression to identify predictors of amenorrhea at 12 months. The predictor analysis only included women not using a levonorgestrel IUS in the month prior to study enrollment. Results: In the month before enrollment, 148 and 1566 women, respectively, had used and not used a levonorgestrel IUS. Prior users averaged 50±19 months of use before IUS placement; 38.4% of these women reported amenorrhea at 12 months. Amenorrhea rates for non-prior-users at 3, 6, 9 and 12 months were 0.2%, 9.1%, 17.2% and 16.9%, respectively. During the first 12 months, 29 (1.7%) women discontinued for bleeding irregularities; no women discontinued for amenorrhea. The only significant predictor of amenorrhea at 12 months was self-reported baseline duration of menstrual flow of fewer than 7 days vs. 7 or more days (18.2% vs. 5.2%, adjusted odds ratio 3.70 [1.69, 8.07]). We found no relationships between 12-month amenorrhea rates and age, parity, race, body mass index, baseline flow intensity or hormonal contraception use immediately prior to IUS placement. Conclusions: Amenorrhea rates during the first year of levonorgestrel 52 mg IUS use are similar at 9 and 12 months. Amenorrhea at 12 months is most common among women with shorter baseline duration of menstrual flow. Implications statement: This information provides more data for clinicians when counseling women about amenorrhea expectations, especially since women seeking a levonorgestrel 52 mg IUS for contraception are different than women desiring treatment for heavy menstrual bleeding. Amenorrhea at 12 months is most common among women with shorter baseline duration of menstrual flow.

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Section: Discussionmentioning

confidence: 99%

Amenorrhea rates and predictors during 1 year of levonorgestrel 52 mg intrauterine system use

et al. 2018

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“…14 The Pearl Index over the full 5 years was 0.29 (95% CI 0.16 to 0.50). In years 4 and 5, there were an additional two intrauterine pregnancies and one additional ectopic pregnancy.…”

Section: What Is Kyleena?mentioning

confidence: 97%

“…14 The most frequent adverse effects leading to discontinuation were vaginal bleeding (3.5%), device expulsion (3.0%) and pelvic pain (3.0%). Around 23% of women had ovarian cysts recorded as adverse effects (abnormal, non-functional cysts and/or >3cm in diameter, regardless of the presence or absence of any associated clinical symptoms, recorded during ultrasounds performed at each study visit).…”

Section: What Is Kyleena?mentioning

confidence: 99%

Kyleena – another levonorgestrel IUS

2018

DTB

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A levonorgestrel (LNG) intrauterine system (IUS) known as Kyleena (Bayer PLC) received marketing authorisation from the European Medicines Agency in 2016. The device contains 19.5mg LNG and is licensed for contraception for up to 5 years. This is the fourth LNG IUS product to be licensed for use in the UK. The company states that Kyleena offers advantages over Mirena and Jaydess LNG IUS devices. Here we consider the evidence for Kyleena.

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“…5 The five-year cumulative Pearl Index was 0.29. A further 22% of women discontinued use during the two-year period, of whom just over a fifth did so due to adverse effects.…”

Section: Efficacymentioning

confidence: 99%

“…3 Over the five-year period, the most frequent adverse events associated with Kyleena that were considered treatment-related were ovarian cyst (16%), acne (10%), pelvic pain (6.3%), dysmenorrhoea (5.4%) and vaginal haemorrhage (5.0%). 5 …”

Section: Adverse Effectsmentioning

confidence: 99%