ContraceptionNCT02349815
JAYDESS Drug Utilization Study in Sweden
An observational study of Contraception, run by Bayer at 1 site in Sweden.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 64 years, women only
- Conditions the study is for
- Contraception
- What is being tested?
- Levonorgestrel (Jaydess, Skyla, BAY86-5028)
- How many people
- 10,000 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2017to 1 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- Women only
- No healthy volunteers
- Adult
Study population: Women in Sweden
Who may be able to join
- Swedish women who were dispensed a JAYDESS from a Swedish Pharmacy anytime 2014-2017
Who cannot join
- No exclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Contraception
- Being tested
- Levonorgestrel (Jaydess, Skyla, BAY86-5028)
- Keywords
- Drug Utilization Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levonorgestrel (Jaydess, Skyla, BAY86-5028)Drug
Women use Levonorgestrel (Jaydess, BAY86-5028) .
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Women prescribed JAYDESS in Sweden Receives: Drug: Levonorgestrel (Jaydess, Skyla, BAY86-5028) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of use of JAYDESS
Measured: Up to 6 years
Indication for use
Measured: At insertion
Secondary outcomes (1)
Age at insertion and removal
Measured: Up to 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2015 (estimated)
- Study start1 Jan 2017
- Primary completion1 Apr 2022
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 10,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Karolinska Institutet
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02349815
- Sponsor's protocol ID
- 16903
- Other IDs
- JD1311SE
- Status last verified
- Jan 2023
- First submitted
- 26 Jan 2015
- Last updated
- 31 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacoepidemiological Study (Drug Utilization Study) of JAYDESS Use in Routine Clinical Practice in Sweden
- ClinicalTrials.gov ID
- NCT02349815
- Acronym / sponsor ID
- 16903
- Conditions
- Contraception
- Keywords
- Drug Utilization Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,000 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Karolinska Institutet
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 29 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Levonorgestrel (Jaydess, Skyla, BAY86-5028)Women prescribed JAYDESS in Sweden |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women in Sweden
Key inclusion criteria (1 listed)
- Swedish women who were dispensed a JAYDESS from a Swedish Pharmacy anytime 2014-2017
Key exclusion criteria (1 listed)
- No exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Levonorgestrel (Jaydess, Skyla, BAY86-5028)Women use Levonorgestrel (Jaydess, BAY86-5028) . | Drug | Group 1 |
Primary outcome
Duration of use of JAYDESS
Time frame: Up to 6 years
Indication for use
Time frame: At insertion
1 secondary outcome
Age at insertion and removal
Time frame: Up to 6 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Contraception, run by Bayer at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of use of JAYDESS (time frame: Up to 6 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2023; AzTrials last refreshed its copy on 28 Oct 2026.