NCT02349815CompletedNot Applicable
Pharmacoepidemiological Study (Drug Utilization Study) of JAYDESS Use in Routine Clinical Practice in Sweden
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Bayer
- Enrollment
- 10,000
- Locations
- 1
- Primary Endpoint
- Indication for use
Study Overview
Brief Summary
- To describe characteristics (demographic, clinical, social) of first time users of Jaydess
- To estimate the duration of use of Jaydess
- To study switching patterns, e.g. what are the hormonal contraceptive methods used before and what are the methods after discontinuing Jaydess
- To study off-label use of Jaydess
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Swedish women who were dispensed a JAYDESS from a Swedish Pharmacy anytime 2014-2017
Exclusion Criteria
- •No exclusion criteria
Arms & Interventions
Group 1
Women prescribed JAYDESS in Sweden
Intervention: Levonorgestrel (Jaydess, Skyla, BAY86-5028) (Drug)
Outcomes
Primary Outcomes
Indication for use
Time Frame: At insertion
Duration of use of JAYDESS
Time Frame: Up to 6 years
Secondary Outcomes
- Age at insertion and removal(Up to 6 years)
Investigators
Study Sites (1)
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