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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
trial testing Kyleena in Contraception in 1,134 participants. Completed in 31 March 2020.
19 December 2019
Quick facts
| Lead sponsor | Bayer |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 1,134 |
| Start date | 6 July 2017 |
| Primary completion | 19 December 2019 |
| Estimated completion | 31 March 2020 |
| Sites | 19 locations across Belgium, Sweden, Germany, Mexico, Norway, Canada, United States, Spain |
Drugs / interventions tested
- Kyleena — full drug profile →
Conditions studied
- Contraception — all drugs for Contraception →
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):
-
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 -
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 -
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 -
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 -
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:
- PubMed search for NCT03182140
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03182140 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Bayer
- Last refreshed: 29 March 2021
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