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Kyleena® (19.5mg Intrauterine Delivery System Levonorgestrel)

Real World Evidence

KYSS Study

The Kyleena® (19.5mg intrauterine delivery system levonorgestrel) Satisfaction Study (KYSS)

KYSS is a prospective, multinational, single-arm, observational study
Kyleena® placement was attempted in 1,129 women and successful in 1,126 women

The majority of women were between 18 and 35 years of age (67.1%, n=756).

Parity and previous methods of contraception

^{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.}
^{† Either a COC or a POP.}
^{‡ "Other" includes all methods with <10% of women using them: vaginal HC (3.1%), non-hormonal IUD (3.0%), natural planning (1.2%), implant (0.7%), Injectables, transdermal HC (0.2%) and backup contraception (0.09%).}
^{COC – combined oral contraceptive; HC – hormonal contraception; IUD – intrauterine device; IUS – intrauterine system; KYSS – Kyleena Satisfaction Study; POP – progestogen-only pill.}

Women want more from their contraception than just clinical efficacy:

Kyleena: placement rated as easy for most women regardless of parity

Misperceptions around IUS placement may be a barrier to its use among parous and nulliparous women, but the RWE from KYSS can bring confidence to your patients (n=1,110)

Kyleena®: high satisfaction rates, irrespective of age

Percentage of women satisfied with Kyleena, by age^*

≤ 17 years

(N=22)

18-25 years

(N=327)

26-35 years

(N=314)

> 35 years

(N=305)

^{Adapted from Stovall DW et al 2021}
^{* Results shown represent women who reported being "very satisfied" or "Somewhat satisfied" with Kyleena at the end of the final visit.}

Most women were satisfied with Kyleena®,* no matter their...

Previous contraception
^†

85.2%

of women who

switched from an oral HC

were satisfied (n=317).

Motivation for choosing Kyleena
^®†

84.3%

of women chose Kyleena® mainly for its

low-hormone dose

were satisfied (n=248).

^{* Results shown represent women who reported being "very satisfied" or "somewhat satisfied" with Kyleena® at the end of the final visit.}
^{† Results shown for each of the topics mentioned are representative of one of the subgroups only. Not all patients had the same previous contraception, motivation for choosing Kyleena®, or country of residency.}
^{HC - hormonal contraception}

Kyleena® demonstrated a high level of satisfaction with bleeding profile in KYSS

Bleeding profile satisfaction is important, as it can significantly impact women's quality of life

^{* A total of 632/887 women in KYSS reported their satisfaction with their bleeding profile profile while on Kyleena®.}
^{KYSS- Kyleena® Satisfaction Study}

81.5% of patients in the patient safety analysis group experienced no adverse events with Kyleena
^®*

Discontinued Kyleena® due to TEAEs and TESAEs, respectively

^{§ The most common TEAEs were gastrointestinal disorders 3.3%, reproductive system and breast disorders 9.5% and infections and infestations 2.3%.}
^{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

Few women discontinued Kyleena® in KYSS

Discontinuation SAF, n(%)	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 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 (0.1)
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}

KYSS: new perspectives on Kyleena® Summary

Women

want more from their contraception

than just reliable efficacy, such as no contraceptive routine and low hormone doses.

Most Kyleena® placements were

rated as easy by HCPs

and associated with no or mild pain for women.

Kyleena® was associated with

high levels of satisfaction

, regardless of age and/or parity*

Women were generally

satisfied with their bleeding

profile while on Kyleena® – with only 2.5% of women discontinuing due to dissatisfaction with their bleeding profile

The number of women experiencing adverse events with Kyleena® was low overall, with few related discontinuations

Patient Case Studies:

Jade: Anxious about hormones

23-year-old non-smoker anxious about hormones and wants a non-hormonal contraceptive option.

PP-KYL-IE-0259-1, January 2026

Mandy: The tricky fit

This patient has been referred to you from a colleague "unable to pass an uterine sound".

PP-KYL-IE-0260-1, January 2026

Sonila: The forgetful pill taker

19-year-old university student struggling to remember to take her pill every day but is concerned about an unplanned pregnancy.

PP-KYL-IE-0261-1, January 2026

PP-KYL-IE-0256-1 | January 2026

References

1
Stovall DW et al. Eur J Contracept Reprod Health Care 2021
2
Beckert V et al. Eur J Contracept Reprod Health Care 2020;25:182–189.
3
Black K et al. Eur J Contracept Reprod Health Care 2012;17(5):340–348.
4
Daniele MAS et al. Reprod Health 2017;14:119.
5
Akdemir Y and Karadeniz M. Eur J Contracept Reprod Health Care 2019;24(3):240–245.
6
Bayer Ltd. Kyleena® Summary of Product Characteristics.
7
Schoep ME et al. BMJ Open 2019;9(6):026186.
8
Schoep ME et al. AM J Obstet Gynecol 2019;220(6):569.
9
Sveindóttie H. J Clin Nurs 2018;27(3-4):e503-e513