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

Abstract

Abstract Purpose: The Kyleena™ Satisfaction Study (KYSS) provided the first data on 19.5mg levonorgestrel-releasing intrauterine system (LNG-IUS-19.5mg) 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-19.5mg 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-19.5mg 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-19.5mg 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-19.5mg. 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-19.5mg-related TEAE. Conclusion: Our real-world findings on LNG-IUS-19.5mg 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)