JAYDESS Drug Utilization Study in Sweden | NCT02349815

Studies
JAYDESS Drug Utilization Study in Sweden

NCT02349815

Sponsor

Bayer

Status

Completed

Last Update Posted

Jan 31, 2023Actual

Enrollment

10,000Actual

Phase

Not provided

Conditions

Contraception

Interventions

Levonorgestrel (Jaydess, Skyla, BAY86-5028)

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
JD1311SE	Other Identifier	Company internal

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2017Actual

Primary Completion Date

Apr 1, 2022Actual

Completion Date

Apr 1, 2022Actual

First Submitted Date

Jan 26, 2015

First Submission Date that Met QC Criteria

Jan 26, 2015

First Posted Date

Jan 29, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 29, 2023

Last Update Posted Date

Jan 31, 2023Actual

Name	Class
Karolinska Institutet	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10,000Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1		Women prescribed JAYDESS in Sweden	Drug: Levonorgestrel (Jaydess, Skyla, BAY86-5028)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Levonorgestrel (Jaydess, Skyla, BAY86-5028)	Drug	Women use Levonorgestrel (Jaydess, BAY86-5028) .	Group 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Duration of use of JAYDESS		Up to 6 years
Indication for use		At insertion

Secondary Outcomes

Measure	Description	Time Frame
Age at insertion and removal		Up to 6 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

No exclusion criteria

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

64 Years

Standard Ages

Adult

Study Population

Women in Sweden

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Many Locations		Multiple Locations			Sweden

Intervention Browse Module

MeSH Terms

ID	Term
D016912	Levonorgestrel

Ancestor Terms

ID	Term
D009644	Norgestrel
D009652	Norpregnenes
D009650	Norpregnanes
D009654	Norsteroids
D013256

Browse Leaves

Not provided

Browse Branches

Not provided