ContraceptionKYSSNCT03182140
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
An observational study of Contraception, run by Bayer at 19 sites in 8 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- Kyleena
- How many people
- 1,134 participants
- Where
- 19 sitesin 8 countries
- Study dates
- 6 Jul 2017to 31 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Women in the respective participating country requesting contraception with Kyleena will be eligible to be enrolled. Women can be screened for the study only after an informed decision for Kyleena has been made by the woman and the treating health care professional such as her physician/gynecologist or midwife. Indication and contraindications according to the local market authorization/ summary of product characteristics (SmPC) should be carefully considered.
Who may be able to join
- Women requesting contraception with Kyleena. The woman's informed decision for contraception with Kyleena was made before and independently from the study as per investigator's routine practice
- Written informed consent.
Who cannot join
- Contraindications for Kyleena according to the local market authorization/SmPC
- Mental incapacity to consent and provide data during the observational study
- Women participating in an investigational program with interventions outside of routine clinical practice.
Trial locations and contacts
19 sites in 8 countries.
19 sites in 8 countries
United States12 sites
Radiant Research
Akron, Ohio, 44311
Physician's Research
Draper, Utah, 84020
New England Center for Clinical Research Primacare Research, LLC
Fall River, Massachusetts, 02721
TMC Life Research
Houston, Texas, 77054
Jennifer Grube, MD, FACOG
Lakewood, Colorado, 80228
Lawrence OB/GYN Clinical Research, LLC
Lawrenceville, New Jersey, 08648
Eastern Carolina Women's Center
New Bern, North Carolina, 28562
Physician's Research Options LLC - Revere Women's Health OB/GYN Clinic
Pleasant Grove, Utah, 84062
ProHEALTH Care Associates
Port Jefferson, New York, 11777
Saginaw Valley Medical Research Group, LLC
Saginaw, Michigan, 48604
Physician Care Clinical Research LLC
Sarasota, Florida, 34239
Visions Clinical Research
Wellington, Florida, 33414
About this study
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.
- Conditions
- Contraception
- Being tested
- Kyleena
- Keywords
- long-acting contraception,, unintended pregnancy, satisfaction, bleeding profile, amenorrhea
- Medical subject headings
- Personal Satisfaction, Amenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KyleenaDrug
Kyleena - intrauterine delivery system containing 19.5 mg LNG
| Study group | Role | What they receive |
|---|---|---|
| Kyleena | Non-interventional, observational, uncontrolled study in women that have chosen Kyleena as their contraceptive method before entering the study Receives: Drug: Kyleena |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall satisfaction with Kyleena assessed by questionnaire
The rating is based on the 5-item Likert scale (very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied, very dissatisfied).
Measured: approximately at 12 months after insertion or at premature discontinuation
Secondary outcomes (4)
Overall satisfaction with Kyleena assessed by questionnaire
The rating is based on the 5-item Likert scale (very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied, very dissatisfied).
Measured: approximately 4-12 weeks after insertion
Ease of insertion assessed by investigator
The rating is based on the categories easy, slightly difficult, very difficult.
Measured: Day 1
Pain at insertion assessed by participant
The rating is based on the categories none, mild, moderate, or severe
Measured: Day 1
Satisfaction with the menstrual bleeding profile with Kyleena assessed by questionnaire
Satisfaction with the menstrual bleeding profile with Kyleena assessed by women who did and did not experience menstrual bleeding during the last three months when answering the question "How satisfied were you with your menstrual bleeding pattern?" respectively.
The rating is based on the 5-item Likert scale (very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied, very dissatisfied).
Measured: after approximately 12 months or at premature discontinuation and approximately 4-12 weeks after insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2017
- Study start6 Jul 2017
- Primary completion19 Dec 2019
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03182140
- Sponsor's protocol ID
- 19186
- Acronym
- KYSS
- Status last verified
- Mar 2021
- First submitted
- 19 May 2017
- Last updated
- 29 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Romer T, Frenz AK, Dietrich-Ott S, Fiedler A. The use of LNG-IUS-19.5 mg in daily gynecological routine practice in Germany: data from the Kyleena Satisfaction Study (KYSS). Arch Gynecol Obstet. 2024 May;309(5):2021-2030. doi: 10.1007/s00404-024-07421-5. Epub 2024 Feb 29.
PubMed 38421421Stovall DW, Aqua K, Romer T, Donders G, Sordal T, Hauck B, Llata ES, Kallner HK, Salomon J, Zvolanek M, Frenz AK, Bohnke T, Bauerfeind A. Satisfaction and continuation with LNG-IUS 12: findings from the real-world kyleena(R) satisfaction study. Eur J Contracept Reprod Health Care. 2021 Dec;26(6):462-472. doi: 10.1080/13625187.2021.1975268. Epub 2021 Sep 16.
PubMed 34528857
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03182140
- Acronym / sponsor ID
- KYSS / 19186
- Conditions
- Contraception
- Keywords
- long-acting contraception,, unintended pregnancy, satisfaction, bleeding profile, amenorrhea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,134 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 6 Jul 2017 (actual)
- Primary completion
- 19 Dec 2019 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 9 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Kyleena | – | Drug: KyleenaNon-interventional, observational, uncontrolled study in women that have chosen Kyleena as their contraceptive method before entering the study |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women in the respective participating country requesting contraception with Kyleena will be eligible to be enrolled. Women can be screened for the study only after an informed decision for Kyleena has been made by the woman and the treating health care professional such as her physician/gynecologist or midwife. Indication and contraindications according to the local market authorization/ summary of product characteristics (SmPC) should be carefully considered.
Key inclusion criteria (2 listed)
- Women requesting contraception with Kyleena. The woman's informed decision for contraception with Kyleena was made before and independently from the study as per investigator's routine practice
- Written informed consent.
Key exclusion criteria (3 listed)
- Contraindications for Kyleena according to the local market authorization/SmPC
- Mental incapacity to consent and provide data during the observational study
- Women participating in an investigational program with interventions outside of routine clinical practice.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KyleenaKyleena - intrauterine delivery system containing 19.5 mg LNG | Drug | Kyleena |
Primary outcome
Overall satisfaction with Kyleena assessed by questionnaire
Time frame: approximately at 12 months after insertion or at premature discontinuation
The rating is based on the 5-item Likert scale (very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied, very dissatisfied).
4 secondary outcomes
Overall satisfaction with Kyleena assessed by questionnaire
Time frame: approximately 4-12 weeks after insertion
Ease of insertion assessed by investigator
Time frame: Day 1
Pain at insertion assessed by participant
Time frame: Day 1
Satisfaction with the menstrual bleeding profile with Kyleena assessed by questionnaire
Time frame: after approximately 12 months or at premature discontinuation and approximately 4-12 weeks after insertion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2021.
- Derived from this study: PubMed 38421421Romer T, Frenz AK, Dietrich-Ott S, Fiedler A. The use of LNG-IUS-19.5 mg in daily gynecological routine practice in Germany: data from the Kyleena Satisfaction Study (KYSS). Arch Gynecol Obstet. 2024 May;309(5):2021-2030. doi: 10.1007/s00404-024-07421-5. Epub 2024 Feb 29.
- Derived from this study: PubMed 34528857Stovall DW, Aqua K, Romer T, Donders G, Sordal T, Hauck B, Llata ES, Kallner HK, Salomon J, Zvolanek M, Frenz AK, Bohnke T, Bauerfeind A. Satisfaction and continuation with LNG-IUS 12: findings from the real-world kyleena(R) satisfaction study. Eur J Contracept Reprod Health Care. 2021 Dec;26(6):462-472. doi: 10.1080/13625187.2021.1975268. Epub 2021 Sep 16.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
19 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Contraception, run by Bayer at 19 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States, Belgium, Canada, Germany, Mexico and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall satisfaction with Kyleena assessed by questionnaire (time frame: approximately at 12 months after insertion or at premature discontinuation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03182140, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2021.