JAYDESS Drug Utilization Study in Sweden

Completed

• Conditions: Contraception
• Interventions: Drug: Levonorgestrel (Jaydess, Skyla, BAY86-5028)

• Registration Number: NCT02349815
• Lead Sponsor: Bayer

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-01-26
• Study First Submitted QC: 2015-01-26
• Study First Posted: 2015-01-29
• Study Start: 2017-01-01
• Primary Completion: 2022-04-01
• Study Completion: 2022-04-01
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-29
• Last Update Posted: 2023-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 10000

Inclusion Criteria

• Swedish women who were dispensed a JAYDESS from a Swedish Pharmacy anytime 2014-2017

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Exclusion Criteria

No exclusion criteria

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Levonorgestrel (Jaydess, Skyla, BAY86-5028)	Women prescribed JAYDESS in Sweden

Primary Outcome Measures

Name	Time	Method
Indication for use	At insertion
Duration of use of JAYDESS	Up to 6 years

Secondary Outcome Measures

Name	Time	Method
Age at insertion and removal	Up to 6 years

Trial Locations

Locations (1)

Many Locations; 🇸🇪 Multiple Locations, Sweden