A 12-month multicenter, randomized study comparing the levonorgestrel intrauterine system with the etonogestrel subdermal implant

Apter, Dan; Briggs, Paula; Tuppurainen, Marjo; Grunert, Julia; Lukkari-Lax, Eeva; Rybowski, Sarah; Gemzell‐Danielsson, Kristina

doi:10.1016/j.fertnstert.2016.02.036

Cited by 46 publications

(40 citation statements)

References 14 publications

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“…In total, we included 35 cases of women with an EP during use of LNG‐IUS 13.5 mg and 13 cases during use of LNG‐IUS 52 mg. This makes the current study the largest to date for LNG‐IUS 13.5 mg with almost 3 times the number of cases of all previous studies combined …”

Section: Discussionmentioning

confidence: 90%

“…In our study we estimated the PI for LNG‐IUS 52 mg to be 0.006 (95% CI 0.00‐0.01) during the follow‐up period of 40 months. Previously published data on effectiveness and safety of LNG‐IUS 13.5 in perfect use derives from 6 clinical trials, which were all sponsored by the manufacturer, Bayer . Pregnancy and subsequently EP is a rare outcome in the use of intrauterine contraception.…”

Section: Discussionmentioning

confidence: 99%

“…Previously published data on the LNG‐IUS 13.5 mg are from six clinical trials, all funded by the manufacturer . In these studies, the LNG‐IUS 13.5 mg provided well‐tolerated and effective contraception.…”

Section: Introductionmentioning

confidence: 99%

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Levonorgestrel intrauterine contraceptive systems (13.5 mg and 52 mg) and risk of ectopic pregnancy

Graner

Taggart

Nordström

et al. 2019

Acta Obstet Gynecol Scand

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Introduction:The objective was to investigate the Pearl index for ectopic pregnancy in women using the levonorgestrel intrauterine system (LNG-IUS) at the time of conception. Material and methods:This was a substudy of a hospital-based historical cohort including women with an ectopic pregnancy diagnosed in 4 referral hospitals in Stockholm, Sweden between December 2013 and April 2017. Study participants and type of contraception at time of conception were identified through the electronic medical chart system. Cases were defined as women with LNG-IUS 13.5 or 52 mg in situ at the time of diagnosis of ectopic pregnancy who had their LNG-IUS inserted 1 January 2014 or later. Outcome was defined as the incidence rate for ectopic pregnancy during use per 100 woman-years (Pearl index) with 95% confidence interval (95% CI). Results:The study includes 35 cases with LNG-IUS 13.5 mg and 13 cases with LNG-IUS 52 mg, which occurred in 18 488 (13.5 mg) and 50 246 (52 mg) exposed woman-years. Pearl index for ectopic pregnancy was estimated at 0.19 (95% CI 0.15-0.28) for LNG-IUS 13.5 mg and to 0.006 (95% CI 0.00-0.01) for LNG-IUS 52 mg.The most cases for the LNG-IUS 13.5 mg (n = 26; 74%) occurred during the first year of use with a corresponding Pearl index at 0.23 (95% CI 0.14-0.35). Conclusions:The absolute risk of ectopic pregnancy during the use of LNG-IUS remains low. Our method may underestimate as well as overestimate the Pearl index for ectopic pregnancy. The findings underline the importance of identifying risk factors for ectopic pregnancy at insertion, and to rule out ectopic pregnancy for all women presenting with abdominal discomfort during the use of LNG-IUS. Longer observation periods and prospective studies in a general population are a priority for further research. K E Y W O R D SEctopic pregnancy, intrauterine contraception, levonorgestrel containing intrauterine system, levonorgestrel containing intrauterine system 13.5 mg, levonorgestrel containing intrauterine system 52 mg, Pearl index

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Section: Discussionmentioning

confidence: 90%

Section: Discussionmentioning

confidence: 99%

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Levonorgestrel intrauterine contraceptive systems (13.5 mg and 52 mg) and risk of ectopic pregnancy

Graner

Taggart

Nordström

et al. 2019

Acta Obstet Gynecol Scand

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“…0,3 %. Die Depressionsraten vor der Insertion waren in dieser Studie nicht angegeben [24]. In einer weiteren Studie fand sich unter LNG-IUS eine Rate depressiver Verstimmungen von 0,7 % [78].…”

Section: Lng-ius Und Die Psycheunclassified

“…Risiko kardiovaskulärer Erkrankungen laut WHO unter LNG-IUS vs. KHK; mod. nach[20,24,25]. Die LNG-IUS Mirena ® , Jaydess ® und Kyleena ™ im Vergleich.Ein weiteres Hemmnis, Intrauterinsysteme auch bei Nulliparae anzuwenden, ist die Sorge vor einer vermeintlich erhöhten Perforationsgefahr.…”

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Kyleena™ Paradigmenwechsel in der Verhütung durch das neue Levonorgestrel-freisetzende Intrauterinsystem – Verhaltensunabhängige, sichere Langzeitkontrazeption (Sponsor: Jenapharm GmbH & Co. KG, Jena)

2017

TDR

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ZusammenfassungSeit Kurzem steht mit Kyleena™ eine neue Verhütungsoption in Deutschland zur Verfügung. Wie alle Levonorgestrel-freisetzenden Intrauterinsyteme (LNG-IUS) gehört Kyleena ™ zu den lang wirksamen reversiblen Kontrazeptionsmethoden (Long Acting Reversible Contraception, LARC) und zeichnet sich durch eine verhaltensunabhängig hohe Verhütungssicherheit sowie einer kontrazeptiven Wirkung in der Gebärmutter aus. Die Nachfrage nach solchen langfristigen Kontrazeptionsmethoden ist hoch, gerade bei jungen Frauen: In der aktuell publizierten TANCO-Studie zeigten mehr als zwei Drittel der befragten Patientinnen Interesse an LARC-Optionen; dies galt in besonderem Maße für die Altersgruppen von 14–19 sowie von 20–24 Jahren.

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Progestogen-releasing intrauterine systems for heavy menstrual bleeding

Rodriguez

Lethaby

Jordan

2020

Cochrane Database of Systematic Reviews

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A 12-month multicenter, randomized study comparing the levonorgestrel intrauterine system with the etonogestrel subdermal implant

Abstract: NCT01397097.

Cited by 46 publications

References 14 publications

Levonorgestrel intrauterine contraceptive systems (13.5 mg and 52 mg) and risk of ectopic pregnancy

Levonorgestrel intrauterine contraceptive systems (13.5 mg and 52 mg) and risk of ectopic pregnancy

Kyleena™ Paradigmenwechsel in der Verhütung durch das neue Levonorgestrel-freisetzende Intrauterinsystem – Verhaltensunabhängige, sichere Langzeitkontrazeption (Sponsor: Jenapharm GmbH & Co. KG, Jena)

Progestogen-releasing intrauterine systems for heavy menstrual bleeding

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