Clinical trial NCT03182140: 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Contraception
Keywords: long-acting contraception,
unintended pregnancy
satisfaction
bleeding profile
amenorrhea
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2017-06-09
Enrollment: 1134
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Overall satisfaction with Kyleena assessed by questionnaire
timeFrame: approximately at 12 months after insertion or at premature discontinuation
Secondary outcomes:
measure: Overall satisfaction with Kyleena assessed by questionnaire
timeFrame: approximately 4-12 weeks after insertion
measure: Ease of insertion assessed by investigator
timeFrame: Day 1
measure: Pain at insertion assessed by participant
timeFrame: Day 1
measure: Satisfaction with the menstrual bleeding profile with Kyleena assessed by questionnaire
timeFrame: after approximately 12 months or at premature discontinuation and approximately 4-12 weeks after insertion
Other outcomes:
Locations:
city: Lakewood
country: United States
facility: Jennifer Grube, MD, FACOG
state: Colorado
city: Sarasota
country: United States
facility: Physician Care Clinical Research LLC
state: Florida
city: Wellington
country: United States
facility: Visions Clinical Research
state: Florida
city: Fall River
country: United States
facility: New England Center for Clinical Research Primacare Research, LLC
state: Massachusetts
city: Saginaw
country: United States
facility: Saginaw Valley Medical Research Group, LLC
state: Michigan
city: Lawrenceville
country: United States
facility: Lawrence OB/GYN Clinical Research, LLC
state: New Jersey
city: Port Jefferson
country: United States
facility: ProHEALTH Care Associates
state: New York
city: New Bern
country: United States
facility: Eastern Carolina Women's Center
state: North Carolina
city: Akron
country: United States
facility: Radiant Research
state: Ohio
city: Houston
country: United States
facility: TMC Life Research
state: Texas
city: Draper
country: United States
facility: Physician's Research
state: Utah
city: Pleasant Grove
country: United States
facility: Physician's Research Options LLC - Revere Women's Health OB/GYN Clinic
state: Utah
city: Multiple Locations
country: Belgium
facility: Many locations
city: Multiple Locations
country: Canada
facility: Many locations
city: Multiple Locations
country: Germany
facility: Many locations
city: Multiple Locations
country: Mexico
facility: Many locations
city: Multiple Locations
country: Norway
facility: Many locations
city: Multiple Locations
country: Spain
facility: Many locations
city: Multiple Locations
country: Sweden
facility: Many locations
Study officials:
References:
citation: 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.