Prescribing information and Adverse event reporting can be found at the bottom of the page
KYSS is a prospective, multinational, single-arm, observational study.
Kyleena® placement was attempted in 1,129 women and successful in 1,126 women1
Adapted from Stovall DW et al 2021
Participants were recruited from Belgium, Canada, Germany, Mexico, Norway, Sweden, Spain and the USA, from 2017 to 2018.1
COC – combined oral contraceptive; HC – hormonal contraception; IUD – intrauterine device; IUS – intrauterine system; KYSS – Kyleena Satisfaction Study;
POP – progestogen-only pill
No contraceptive routine
Expectation of improved
bleeding pattern†
Low hormone dose
High contraceptive
reliability
No contraceptive routine
Expectation of improved
bleeding pattern†
Low hormone dose
High contraceptive
reliability
87%
of 491 nulliparous women in KYSS were satisfied with Kyleena®
85.1%
of 477 parous women in KYSS were satisfied with Kyleena®
Satisfaction was similarly high for both parous and nulliparous women1
Adapted from Stovall DW et al 2021
HC – hormonal contraception
Bleeding profile satisfaction is important, as it can significantly impact women’s quality of life2-4
KYSS – Kyleena® Satisfaction Study
6.1%
(n=69)
and
0.4%
(n=4)
Discontinued Kyleena® due to TEAEs
and TESAEs, respectively1
SAF – safety analysis set; TEAE – treatment-emergent adverse event; TESAE – treatment-emergent serious adverse event.
Please refer to the SmPC for the full summary of Kyleena's safety profile
Discontinuation | Total (N=1,129) |
---|---|
Kyleena® still in use at planned EoO | 919 (81.4) |
Kyleena® discontinued before planned EoO | 210 (18.6) |
Discontinuation due to TEAEs | 69 (6.1) |
Discontinuation due to TESAEs | 4 (0.4) |
Primary reason for discontinuation |
|
Unsuccessful Kyleena® placement attempt | 3 (0.3) |
Lost to follow-up | 105 (9.3) |
Expulsion of Kyleena® | 6 (0.5) |
Removal of Kyleena® | 94 (8.3) |
(Serious) adverse event | 62 (5.5) |
Pregnancy | 3 (0.3) |
Wish for pregnancy | 11 (1.0) |
Switch contraceptive methods | 6 (0.5) |
Dissatisfaction with Kyleena® | 9 (0.8) |
Investigator decision | 1 (0.09) |
Not specified | 0 (0.0) |
Adapted from Stovall DW et al 2021
EoO – end of observation period; KYSS – Kyleena® Satisfaction Study; SAF – safety analysis set;
TEAE – treatment-emergent adverse event; TESAE – treatment-emergent serious adverse event
PP-PF-WHC-GB-1132 August 2022
Reporting adverse events and quality complaints
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Bayer plc.
If you want to report an adverse event or quality complaint, reports can be directed to: Tel: 01182063500 or email: pvuk@bayer.com
Further information is available on the “contact” tab at www.bayer.co.uk.