NCT02349815

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 29, 2015

Completed
1.9 years until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

January 31, 2023

Status Verified

January 1, 2023

Enrollment Period

5.2 years

First QC Date

January 26, 2015

Last Update Submit

January 29, 2023

Conditions

Contraception

Keywords

Drug Utilization Study

Outcome Measures

Primary Outcomes (2)

  • Duration of use of JAYDESS

    Up to 6 years

  • Indication for use

    At insertion

Secondary Outcomes (1)

  • Age at insertion and removal

    Up to 6 years

Study Arms (1)

Group 1

Women prescribed JAYDESS in Sweden

Drug: Levonorgestrel (Jaydess, Skyla, BAY86-5028)

Interventions

Levonorgestrel (Jaydess, Skyla, BAY86-5028)DRUG

Women use Levonorgestrel (Jaydess, BAY86-5028) .

Group 1

Eligibility Criteria

Age18 Years - 64 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Women in Sweden

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Many Locations

Multiple Locations, Sweden

Location

Related Links

MeSH Terms

Interventions

Levonorgestrel

Intervention Hierarchy (Ancestors)

NorgestrelNorpregnenesNorpregnanesNorsteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2015

First Posted

January 29, 2015

Study Start

January 1, 2017

Primary Completion

April 1, 2022

Study Completion

April 1, 2022

Last Updated

January 31, 2023

Record last verified: 2023-01

Locations

SE(1)