- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02349815
JAYDESS Drug Utilization Study in Sweden
December 19, 2022 updated by: Bayer
Pharmacoepidemiological Study (Drug Utilization Study) of JAYDESS Use in Routine Clinical Practice in Sweden
- 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 Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
10000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Multiple Locations, Sweden
- Many locations
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 62 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Women in Sweden
Description
Inclusion Criteria:
- Swedish women who were dispensed a JAYDESS from a Swedish Pharmacy anytime 2014-2017
Exclusion Criteria:
No exclusion criteria
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Group 1
Women prescribed JAYDESS in Sweden
|
Women use Levonorgestrel (Jaydess, BAY86-5028) .
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Duration of use of JAYDESS
Time Frame: Up to 6 years
|
Up to 6 years
|
Indication for use
Time Frame: At insertion
|
At insertion
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Age at insertion and removal
Time Frame: Up to 6 years
|
Up to 6 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2017
Primary Completion (Anticipated)
December 31, 2022
Study Completion (Anticipated)
December 31, 2022
Study Registration Dates
First Submitted
January 26, 2015
First Submitted That Met QC Criteria
January 26, 2015
First Posted (Estimate)
January 29, 2015
Study Record Updates
Last Update Posted (Actual)
December 20, 2022
Last Update Submitted That Met QC Criteria
December 19, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16903
- JD1311SE (Other Identifier: Company internal)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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