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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Kyleena | Non-interventional, observational, uncontrolled study in women that have chosen Kyleena as their contraceptive method before entering the study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kyleena | Drug | Kyleena - intrauterine delivery system containing 19.5 mg LNG |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | approximately at 12 months after insertion or at premature discontinuation |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | approximately 4-12 weeks after insertion |
| Ease of insertion assessed by investigator |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jennifer Grube, MD, FACOG | Lakewood | Colorado | 80228 | United States | ||
| Physician Care Clinical Research LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38421421 | Derived | 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. | |
| 34528857 | Derived | Stovall 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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The rating is based on the categories easy, slightly difficult, very difficult. |
| Day 1 |
| Pain at insertion assessed by participant | The rating is based on the categories none, mild, moderate, or severe | 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). | after approximately 12 months or at premature discontinuation and approximately 4-12 weeks after insertion |
| Sarasota |
| Florida |
| 34239 |
| United States |
| Visions Clinical Research | Wellington | Florida | 33414 | United States |
| New England Center for Clinical Research Primacare Research, LLC | Fall River | Massachusetts | 02721 | United States |
| Saginaw Valley Medical Research Group, LLC | Saginaw | Michigan | 48604 | United States |
| Lawrence OB/GYN Clinical Research, LLC | Lawrenceville | New Jersey | 08648 | United States |
| ProHEALTH Care Associates | Port Jefferson | New York | 11777 | United States |
| Eastern Carolina Women's Center | New Bern | North Carolina | 28562 | United States |
| Radiant Research | Akron | Ohio | 44311 | United States |
| TMC Life Research | Houston | Texas | 77054 | United States |
| Physician's Research | Draper | Utah | 84020 | United States |
| Physician's Research Options LLC - Revere Women's Health OB/GYN Clinic | Pleasant Grove | Utah | 84062 | United States |
| Many locations | Multiple Locations | Belgium |
| Many locations | Multiple Locations | Canada |
| Many locations | Multiple Locations | Germany |
| Many locations | Multiple Locations | Mexico |
| Many locations | Multiple Locations | Norway |
| Many locations | Multiple Locations | Spain |
| Many locations | Multiple Locations | Sweden |
| ID | Term |
|---|---|
| D010549 | Personal Satisfaction |
| D000568 | Amenorrhea |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D016912 | Levonorgestrel |
| ID | Term |
|---|---|
| D009644 | Norgestrel |
| D009652 | Norpregnenes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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