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

Autor: Römer T; Obstetrics and Gynecology Department, Academic Hospital Weyertal, University of Cologne, Cologne, Germany. Thomas.Roemer@evk-koeln.de., Frenz AK; Medical Affairs, Bayer AG, Berlin, Germany., Dietrich-Ott S; Jenapharm GmbH & Co. KG, Jena, Germany., Fiedler A; Medical Practice of Obstetrics and Gynecology, Gera/Jena, Germany.
Jazyk: angličtina
Zdroj: Archives of gynecology and obstetrics [Arch Gynecol Obstet] 2024 May; Vol. 309 (5), pp. 2021-2030. Date of Electronic Publication: 2024 Feb 29.
DOI: 10.1007/s00404-024-07421-5
Abstrakt: 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).
(© 2024. The Author(s).)
Databáze: MEDLINE
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