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Observational Study
. 2024 May;309(5):2021-2030.
doi: 10.1007/s00404-024-07421-5. Epub 2024 Feb 29.

The use of LNG-IUS-19.5 mg in daily gynecological routine practice in Germany: data from the Kyleena™ Satisfaction Study (KYSS)

Thomas Römer  1 , Ann-Kathrin Frenz  2 , Susanne Dietrich-Ott  3 , Anja Fiedler  4
Affiliations
Observational Study

The use of LNG-IUS-19.5 mg in daily gynecological routine practice in Germany: data from the Kyleena™ Satisfaction Study (KYSS)

Thomas Römer et al. Arch Gynecol Obstet. 2024 May.

Erratum in

Abstract

Purpose: The Kyleena™ Satisfaction Study (KYSS) provided the first data on 19.5 mg levonorgestrel-releasing intrauterine system (LNG-IUS-19.5 mg) use in routine clinical practice. Here we report results from the German participants in KYSS.

Methods: This prospective, observational, single-arm cohort study recruited women who independently chose to use LNG-IUS-19.5 mg during routine counseling in Germany. Overall satisfaction and bleeding profile satisfaction, continuation rates, and safety profile were evaluated at 12 months or premature end of observation (EoO).

Results: In the German study population, LNG-IUS-19.5 mg placement was attempted in 508 women and successful in 506 women. Mean age was 32.3 years, and 60.0% (n = 305/508) were parous. Placement was considered easy and associated with no more than mild pain, even in younger and nulliparous participants. Of those with satisfaction data available, 87.6% (n = 388/443) were satisfied with LNG-IUS-19.5 mg at 12 months/EoO. Satisfaction was similar for parous (86.9%, n = 238/274) and nulliparous (88.8%, n = 150/169) women, and was independent of age, prior contraceptive method, or reason for choosing LNG-IUS-19.5 mg. Most participants (73.6%, n = 299/406) were also satisfied with their bleeding profile at 12 months/EoO, independent of parity, age, prior contraceptive method, presence of amenorrhea or dysmenorrhea severity. The 12-month continuation rate was 84.1% (n = 427/508). Most discontinuations were due to loss to follow-up (8.5%, n = 43/508) or treatment-emergent adverse events (TEAEs) (4.7%, n = 24/508). TEAEs were reported in 12.6% (n = 64) of participants, with 9.3% (n = 47) considered to have an LNG-IUS-19.5 mg-related TEAE.

Conclusion: Our real-world findings on LNG-IUS-19.5 mg use in German KYSS participants reflected its suitability for a broad population, including young and nulliparous women.

Clinical trial registration: NCT03182140 (date of registration: June 2017).

Keywords: Contraception; Contraceptive safety; Levonorgestrel-releasing intrauterine system; Long-acting reversible contraceptive; Low-dose intrauterine system; Satisfaction.

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Conflict of interest statement

Thomas Römer has received honoraria for lectures and advisory boards from Bayer, Exeltis, Gedeon Richter, Hexal, and Theramex. Ann-Kathrin Frenz is an employee of Bayer AG, Berlin, Germany. Susanne Dietrich-Ott is an employee of Jenapharm GmbH & Co. KG, Jena, Germany. Anja Fiedler declares no conflicts of interest.

Figures

Fig. 1
Fig. 1
Satisfaction of German participants with LNG-IUS-19.5 mg at 12 months/end of observation (full analysis set)a,b
Fig. 2
Fig. 2
Satisfaction of German participants with LNG-IUS-19.5 mg at 12 months/end of observation (FAS), by subgroups. a Level of satisfaction stratified by previous contraceptive methoda,b ; b Level of satisfaction stratified by motivation for choosing LNG-IUS-19.5mgb
Fig. 3
Fig. 3
Satisfaction of German participants with their bleeding profile during LNG-IUS-19.5 mg use (FAS)a,b
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References

    1. Trussell JC. Contraceptive failure in the United States. Contraception. 2011;83:397–404. doi: 10.1016/j.contraception.2011.01.021. - DOI - PMC - PubMed
    1. Winner B, Peipert JF, Zhao Q, Buckel C, Madden T, Allsworth JE, Secura GM. Effectiveness of long-acting reversible contraception. N Engl J Med. 2012;366:1998–2007. doi: 10.1056/NEJMoa1110855. - DOI - PubMed
    1. Römer T, Linsberger D. User satisfaction with a levonorgestrel-releasing intrauterine system (LNG-IUS): data from an international survey. Eur J Contracept Reprod Health Care. 2009;14:391–398. doi: 10.3109/13625180903203154. - DOI - PubMed
    1. Peipert JF, Zhao Q, Allsworth JE, Petrosky E, Madden T, Eisenberg D, Secura G. Continuation and satisfaction of reversible contraception. Obstet Gynecol. 2011;117:1105–1113. doi: 10.1097/AOG.0b013e31821188ad. - DOI - PMC - PubMed
    1. Gemzell-Danielsson K, Cho S, Inki P, Mansour D, Reid R, Bahamondes L. Use of contraceptive methods and contraceptive recommendations among health care providers actively involved in contraceptive counseling – results of an international survey in 10 countries. Contraception. 2012;86:631–638. doi: 10.1016/j.contraception.2012.06.002. - DOI - PubMed

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