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NCT03182140: KYSS

KYleena Satisfaction Study / Observational Study on User Satisfaction With the Levonorgestrel Intrauterine Delivery System Kyleena (LNG-IUS 12) in New Contraceptive Users and After Switching From Another Contraceptive Method

Completed Last updated 29 March 2021
What this trial tests

trial testing Kyleena in Contraception in 1,134 participants. Completed in 31 March 2020.

Timeline
6 July 2017
Primary endpoint
19 December 2019
31 March 2020

Quick facts

Lead sponsorBayer
StatusCompleted
Study typeOBSERVATIONAL
Enrollment1,134
Start date6 July 2017
Primary completion19 December 2019
Estimated completion31 March 2020
Sites19 locations across Belgium, Sweden, Germany, Mexico, Norway, Canada, United States, Spain

Drugs / interventions tested

Conditions studied

Sponsor

Bayer — full company profile →

Who can join

Eligibility, female only, with Contraception. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The main goal of this non-interventional study (NIS) is to evaluate user satisfaction with Kyleena in a real-life setting and to identify factors which influence user satisfaction, taking into account previously used contraceptive methods and reasons for use of Kyleena.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Satisfaction and continuation with LNG-IUS 12: findings from the real-world kyleena<sup>®</sup> satisfaction study.
    Stovall DW, Aqua K, Römer T, Donders G, et al · · 2021 · cited 8× · PMID 34528857 · DOI 10.1080/13625187.2021.1975268
  2. Bleeding profile satisfaction and pain and ease of placement with levonorgestrel 19.5 mg IUD: findings from the Kyleena<sup>®</sup> Satisfaction study.
    Donders G, Kopp Kallner H, Hauck B, Bauerfeind A, et al · · 2023 · cited 6× · PMID 36342694 · DOI 10.1080/13625187.2022.2136939
  3. Insertion experience of women and health care professionals in the Kyleena<sup>®</sup> Satisfaction Study.
    Beckert V, Aqua K, Bechtel C, Cornago S, et al · · 2020 · cited 5× · PMID 32223466 · DOI 10.1080/13625187.2020.1736547
  4. The use of LNG-IUS-19.5 mg in daily gynecological routine practice in Germany: data from the Kyleena™ Satisfaction Study (KYSS).
    Römer T, Frenz AK, Dietrich-Ott S, Fiedler A. · · 2024 · PMID 38421421 · DOI 10.1007/s00404-024-07421-5
  5. The use of LNG-IUS-19.5mg in daily gynecological routine practice in Germany: data from the KyleenaTM Satisfaction Study (KYSS)
    Römer T, Frenz A, Dietrich-Ott S, Fiedler A. · · 2024 · DOI 10.21203/rs.3.rs-3871431/v1

Verify or expand the search:

Other recruiting trials for Contraception

Currently open trials in the same condition.

Other Bayer trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03182140.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing