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NCT02349815 Clinical Trial

JAYDESS Drug Utilization Study in Sweden

Contraception Clinical Trial

Official title:
Pharmacoepidemiological Study (Drug Utilization Study) of JAYDESS Use in Routine Clinical Practice in Sweden

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02349815
Other study ID # 16903
Secondary ID JD1311SE
Status Completed
Phase
First received
Last updated
Start date January 1, 2017
Est. completion date April 1, 2022

Study information
Verified date January 2023
Source Bayer
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 10000
Est. completion date April 1, 2022
Est. primary completion date April 1, 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 64 Years
Eligibility Inclusion Criteria: - Swedish women who were dispensed a JAYDESS from a Swedish Pharmacy anytime 2014-2017 Exclusion Criteria: No exclusion criteria

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Levonorgestrel (Jaydess, Skyla, BAY86-5028)
Women use Levonorgestrel (Jaydess, BAY86-5028) .

Locations
Country Name City State
Sweden Many Locations Multiple Locations

Sponsors (2)
Lead Sponsor Collaborator
Bayer Karolinska Institutet, Stockholm, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Duration of use of JAYDESS Up to 6 years
Primary Indication for use At insertion
Secondary Age at insertion and removal Up to 6 years
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