The use of LNG-IUS-19.5 mg in daily gynecological routine practice in Germany : data from the Kyleena™ Satisfaction Study (KYSS)
© 2024. The Author(s)..
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).
| Errataetall: |
ErratumIn: Arch Gynecol Obstet. 2024 Apr 4;:. - PMID 38573356 |
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| Medienart: |
E-Artikel |
| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:309 |
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| Enthalten in: |
Archives of gynecology and obstetrics - 309(2024), 5 vom: 01. Apr., Seite 2021-2030 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Römer, Thomas [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 16.04.2024 Date Revised 25.04.2024 published: Print-Electronic ClinicalTrials.gov: NCT03182140 ErratumIn: Arch Gynecol Obstet. 2024 Apr 4;:. - PMID 38573356 Citation Status MEDLINE |
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| doi: |
10.1007/s00404-024-07421-5 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM369113403 |
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| 100 | 1 | |a Römer, Thomas |e verfasserin |4 aut | |
| 245 | 1 | 4 | |a The use of LNG-IUS-19.5 mg in daily gynecological routine practice in Germany |b data from the Kyleena™ Satisfaction Study (KYSS) |
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| 500 | |a Date Completed 16.04.2024 | ||
| 500 | |a Date Revised 25.04.2024 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT03182140 | ||
| 500 | |a ErratumIn: Arch Gynecol Obstet. 2024 Apr 4;:. - PMID 38573356 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2024. The Author(s). | ||
| 520 | |a 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 | ||
| 520 | |a 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) | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a CLINICAL TRIAL REGISTRATION: NCT03182140 (date of registration: June 2017) | ||
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| 650 | 4 | |a Contraceptive safety | |
| 650 | 4 | |a Levonorgestrel-releasing intrauterine system | |
| 650 | 4 | |a Long-acting reversible contraceptive | |
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