Prescribing information can be found at the bottom of the page

Real world evidence

The Kyleena® (19.5mg levonorgestrel) Satisfaction Study (KYSS)

 

prescribing information

Kyleena satisfaction study

KYSS is a prospective, multinational, single-arm, observational study.

 

Kyleena® placement was attempted in 1,129 women and successful in 1,126 women1

Parity

Parity

 

N=1,126

Nulliparous women

Parous women

Previous method of contraception

Previous method of contraception

 

N=1,126

Oral HC

None

Hormonal IUS

Barrier methods

Other

Adapted from Stovall DW et al 2021

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

Participants were recruited from Belgium, Canada, Germany, Mexico, Norway, Sweden, Spain and the USA, from 2017 to 2018.1

  • "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%).1 Return to content

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 efficacy1

Overview
 

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

Kyleena: placement rated as easy for most women regardless of parity2

Misperceptions around IUS placement may be a barrier to its use among parous and nulliparous women,3-5 but the RWE from KYSS can bring confidence to your patients2 (n=1,110)

91%

of Kyleena® placements were rated as easy by HCPs2

77.7%

of Kyleena® placements were associated with no or mild pain2

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

  • Stovall DW et al. Eur J Contracept Reprod Health Care 2021 [DOI: 10.1080/13625187.2021.1975268. Online ahead of print]. Including supplementary appendix Return to content
  • Beckert V et al. Eur J Contracept Reprod Health Care 2020;25:182–189. Return to content
  • Black K et al. Eur J Contracept Reprod Health Care 2012;17(5):340–348. Return to content
  • Daniele MAS et al. Reprod Health 2017;14:119. Return to content
  • Akdemir Y and Karadeniz M. Eur J Contracept Reprod Health Care 2019;24(3):240–245 Return to content

Kyleena®: high satisfaction rates, irrespective of age1

Percentage of women satisfied with Kyleena, by age*1

95.5
%

≤ 17 years2
(N=22)

86.6
%

18-25 years
(N=327)

83.1
%

26-35 years
(N=314)

87.8
%

> 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 Return to content

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

Previous contraception

Previous contraception1

85.2%

of women who switched from an oral HC were satisfied (n=317)

Motivation for choosing Kyleena

Motivation for choosing Kyleena®1

84.3%

of women who 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.1 Return to content
  • 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. Return to content

HC – hormonal contraception

Kyleena® demonstrated a high level of satisfaction with the bleeding profile in KYSS1

Bleeding profile satisfaction is important, as it can significantly impact women’s quality of life2-4

71.3%

of women were satisfied with their bleeding profile while on Kyleena®*1

2.5%

discontinued due to dissatisfaction with bleeding profile1

Bleeding profile satisfaction

2.5%

discontinued due to dissatisfaction with bleeding profile1

  • A total of 632/887 women in KYSS reported their satisfaction with their bleeding profile while on Kyleena®.1 Return to content

KYSS – Kyleena® Satisfaction Study

81.5% of patients in the patient safety analysis group experienced no adverse events with Kyleena®1

patient safety analysis

6.1%

(n=69)

and

0.4%

(n=4)

Discontinued Kyleena® due to TEAEs
and TESAEs, respectively1

  • The most common TEAEs were gastrointestinal disorders 3.3%, reproductive system and breast disorders 9.5% and infections and infestations 2.3%1 Return to content

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 KYSS1

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 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

KYSS: new perspectives on Kyleena® Summary

  • Stovall DW et al. Eur J Contracept Reprod Health Care 2021 [DOI: 10.1080/13625187.2021.1975268. Return to content
  • Beckert V et al. Eur J Contracept Reprod Health Care 2020;25:182–189. Return to content

Kyleena case studies

PP-PF-WHC-GB-1037 May 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.