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Trial record 8 of 404 for:    LEVONORGESTREL

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 (KYSS)

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ClinicalTrials.gov Identifier: NCT03182140
Recruitment Status : Active, not recruiting
First Posted : June 9, 2017
Last Update Posted : September 23, 2019
Sponsor:
Information provided by (Responsible Party):
Bayer

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.

Condition or disease Intervention/treatment
Contraception Drug: Kyleena

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Study Type : Observational
Actual Enrollment : 1134 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : July 7, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : March 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

Group/Cohort Intervention/treatment
Kyleena
Non-interventional, observational, uncontrolled study in women that have chosen Kyleena as their contraceptive method before entering the study
Drug: Kyleena
Kyleena - intrauterine delivery system containing 19.5 mg LNG




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Overall satisfaction with Kyleena assessed by questionnaire [ Time Frame: approximately 4-12 weeks after insertion ]
    The rating is based on the 5-item Likert scale (very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied, very dissatisfied).

  2. Ease of insertion assessed by investigator [ Time Frame: Day 1 ]
    The rating is based on the categories easy, slightly difficult, very difficult.

  3. Pain at insertion assessed by participant [ Time Frame: Day 1 ]
    The rating is based on the categories none, mild, moderate, or severe

  4. 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 ]

    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).




Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03182140


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Sponsors and Collaborators
Bayer

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03182140     History of Changes
Other Study ID Numbers: 19186
First Posted: June 9, 2017    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bayer:
long-acting contraception,
unintended pregnancy
satisfaction
bleeding profile
amenorrhea
Additional relevant MeSH terms:
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Contraceptive Agents
Levonorgestrel
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral