JAYDESS Drug Utilization Study in Sweden

• Sponsor: Bayer (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT02349815
• Collaborator: Karolinska Institutet, Stockholm, Sweden (Other)
• Enrollment: 10,000
• Location: 1
• Anticipated Duration (Months): 72
• Patients Per Site Per Month: 139

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Contraception	Drug: Levonorgestrel (Jaydess, Skyla, BAY86-5028)

Study Design

• Study Type: Observational
• Actual Enrollment: 10000 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Pharmacoepidemiological Study (Drug Utilization Study) of JAYDESS Use in Routine Clinical Practice in Sweden
• Actual Study Start Date: Jan 1, 2017
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Group 1 Women prescribed JAYDESS in Sweden	Drug: Levonorgestrel (Jaydess, Skyla, BAY86-5028); Women use Levonorgestrel (Jaydess, BAY86-5028) .

Outcome Measures

Primary Outcome Measures

1. Duration of use of JAYDESS [Up to 6 years]

2. Indication for use [At insertion]

Secondary Outcome Measures

1. Age at insertion and removal [Up to 6 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 64 Years
• Sexes Eligible for Study: 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Many Locations	Multiple Locations		Sweden

Sponsors and Collaborators

• Bayer
• Karolinska Institutet, Stockholm, Sweden

Investigators

• Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT02349815
• Other Study ID Numbers: 16903; JD1311SE
• First Posted: Jan 29, 2015
• Last Update Posted: Aug 22, 2022
• Last Verified: Aug 1, 2022

• Keywords provided by Bayer: Drug Utilization Study
• Additional relevant MeSH terms: Levonorgestrel

Study Results

No Results Posted as of Aug 22, 2022