The Kyleena® Satisfaction Study (KYSS)
KYSS study design1
This prospective, noninterventional, multinational, single-arm cohort study took place in Belgium, Canada, Germany, Mexico, Norway, Sweden, Spain, and the United States (US). All participants were women with different or no previously used contraceptive methods (including women without previous contraception forming one of the subgroups) who had already decided to use Kyleena. In the US, the study was conducted at 12 sites in 100 women. In Belgium, Canada, Mexico, Norway, Sweden, and Spain, the sample size was N = 100 in each country. Germany contained the largest sample size of N = 500. The primary endpoint was to evaluate overall satisfaction with Kyleena at the end of the observation period (12 months) per country. The secondary endpoints included satisfaction with Kyleena at the end of the observation period (12 months) stratified by previously used contraceptive method and motivation for choosing Kyleena, pain severity at Kyleena insertion, ease of Kyleena insertion (investigator assessed), and other measures.
KYSS participants were asked 2 questions pertaining to their contraception usage before having Kyleena placed2
The decision to use an LNG-IUS was made independently by the women after a discussion with their healthcare provider at participating study centers. These discussions were not prompted or scripted; the healthcare providers gave their routine counseling, after which the women could decide to use any contraception method.
Why did you decide to stop your previous method of contraception?
Participants were asked to select from certain options, some of which include the following:
- Afraid the contraceptive method might not be very effective
- Problems with daily, weekly, or monthly contraceptive routine (intake, insertion, injection, application)
- Dissatisfaction with current contraceptive method
- Other, please specify
Why did you decide to use Kyleena for contraception?
Participants were asked to select from certain options, some of which include the following:
- High contraceptive reliability
- No daily, weekly, or monthly contraceptive routine (intake, insertion, injection, application)
- Acts mainly locally
- Low hormone dose
- Estrogen-free contraception
- Small size
- Other, please specify
Understanding the effects of these variables on satisfaction rates may help healthcare providers assist in the counseling and method selection process.
Safety results from the clinical trials3
ADVERSE REACTIONS THAT OCCURRED IN AT LEAST 1% OF KYLEENA USERS IN CLINICAL TRIALS BY SYSTEM ORGAN CLASS
| System Organ Class | Adverse Reaction | Incidence(%) (N=1697) |
|---|---|---|
| Reproductive System and Breast Disorders | Vulvovaginitis | 24.3 |
| Ovarian cysta | 22.2 | |
| Dysmenorrhea/uterine spasm | 8.0/2.4 | |
| Increased bleedingb | 7.9 | |
| Breast pain/discomfort | 7.1/3.5 | |
| Gential discharge | 4.5 | |
| Device expulsion (complete and partial) | 3.5 | |
| Upper genital tract infection | 1.5 | |
| Gastrointestinal Disorders | Abdominal pain/pelvic pain | 13.3/8.2 |
| Nausea | 4.7 |
In the clinical trials, serious adverse reactions occurring in more than a single subject included: ectopic pregnancy/ruptured ectopic pregnancy (10 subjects); pelvic inflammatory disease (6 subjects); missed abortion/incomplete spontaneous abortion/spontaneous abortion (4 subjects); ovarian cyst (3 subjects); abdominal pain (4 subjects); depression/affective disorder (4 subjects); and uterine perforation/embedded device (myometrial perforation) (3 subjects).
aOvarian cysts were reported as adverse events if they were abnormal, non-functional cysts and/or had a diameter >3 cm on ultrasound examination.
bNot all bleeding alterations were captured as adverse reactions.
Safety results and limitations from the KYSS study
Treatment-emergent adverse events (TEAEs) reported in ≥1% of women who received Kyleena in KYSS (N=1129)2
| ADVERSE EVENT | n (%) |
|---|---|
| Reproductive system and breast disorders | 89 (7.9%) |
| Vaginal hemorrhage | 21 (1.9%) |
| Dysmenorrhea | 11 (1.0%) |
| Menorrhagia | 11 (1.0%) |
| Gastrointestinal disorders | 29 (2.6%) |
| Abdominal pain (lower) | 16 (1.4%) |
| Psychiatric disorders | 13 (1.2%) |
| Skin and subcutaneous tissue disorders | 13 (1.2%) |
Women who were using Kyleena most frequently reported TEAEs related to the reproductive system and breast disorders (89 patients, 7.9%), gastrointestinal disorders (29 patients, 2.6%), psychiatric disorders (13 patients,1.2%), and skin and subcutaneous tissue disorders (13 patients, 1.2%). The most frequently reported TEAEs in women using Kyleena were vaginal hemorrhage (21 patients, 1.9%) and lower abdominal pain (16 patients, 1.4%). A total of 69 patients (6.1%) discontinued Kyleena due to TEAEs, 4 of these patients (0.4%) due to treatment-emergent serious adverse events.
Potential study limitations2
- Given the noninterventional study design and limitations inherent to observational studies, findings generated from this study are subject to biases, such as selection bias, limitations to availability of historical medical data, and differences in treatment or reporting owing to local guidelines
- The study population was enrolled in selected countries and sites that might not be comparable to the nonparticipating population. This might also be a limiting factor in generalizing the results
- Investigators were chosen based on feasibility criteria, which might have resulted in decreased generalizability of the study results
- Selection bias could not be excluded completely because potential study participants were predominantly selected among those who wanted to change their previously used contraceptive method because of unsatisfactory experiences
- Since this kind of bias could not be ruled out, an additional group of women without previous contraception (new starters) were included. Results of this subgroup enabled putting the satisfaction results into the right perspective
Overall satisfaction with Kyleena1-2
Satisfaction with Kyleena, evaluated as the primary endpoint, as obtained from the patient questionnaire: How satisfied are you with Kyleena?
Results were taken after 12 months or premature discontinuation1
*Satisfaction is defined as sum of women reported "very satisfied" or "somewhat satisfied"; "unsatisfied" is defined as sum of women reported "neither satisfied nor dissatisfied," "dissatisfied," or "very dissatisfied."
Satisfaction rate with Kyleena in women of all ages by parity
Satisfaction with Kyleena as obtained from the patient questionnaire: How satisfied are you with Kyleena?
Results were taken after 12 months or premature discontinuation1,2
*Satisfaction is defined as sum of women reported "very satisfied" or "somewhat satisfied"; "unsatisfied" is defined as sum of women reported "neither satisfied nor dissatisfied," "dissatisfied," or "very dissatisfied."
*Safety and efficacy of Kyleena have been established in women of reproductive age. Efficacy is expected to be the same for postpubertal females under the age of 18 as for users 18 years and older. Use of this product before menarche is not indicated.
Satisfaction rate with Kyleena in women of all ages by parity
Satisfaction with Kyleena as obtained from the patient questionnaire: How satisfied are you with Kyleena?
Results were taken after 12 months or premature discontinuation1,2
*Satisfaction is defined as sum of women reported "very satisfied" or "somewhat satisfied"; "unsatisfied" is defined as sum of women reported "neither satisfied nor dissatisfied," "dissatisfied," or "very dissatisfied."
*Safety and efficacy of Kyleena have been established in women of reproductive age. Efficacy is expected to be the same for postpubertal females under the age of 18 as for users 18 years and older. Use of this product before menarche is not indicated.
Ease of insertion with Kyleena
Kyleena satisfaction study: secondary endpoints
Ease of insertion2*
Ease of insertion was a secondary endpoint, assessed by investigator at initial visit as easy, slightly difficult, or very difficult.2
Insertion may be associated with some pain and/or bleeding or vasovagal reactions (for example, syncope, bradycardia) or with seizure, especially in patients with a predisposition to these conditions. Consider administering analgesics prior to insertion.
*Data shown are from the Full Analysis Set (FAS). A woman was included in the FAS if the first insertion attempt was successful. That means the FAS excluded subjects with unsuccessful insertion. The FAS was used for all primary and secondary analyses.
Pain at insertion with Kyleena
Kyleena satisfaction study: secondary endpoints
Pain at insertion2*
Counsel on insertion pain. Let your patients know that pain is a common side effect. Patients may experience pain, bleeding, or dizziness during and after placement. If symptoms don’t pass within 30 minutes after placement, Kyleena may not have been placed correctly. The HCP should examine whether or not Kyleena will need to be removed or replaced.
*Data shown are from the Full Analysis Set (FAS). A woman was included in the FAS if the first insertion attempt was successful. That means the FAS excluded subjects with unsuccessful insertion. The FAS was used for all primary and secondary analyses.
