Intrauterine Devices, MedicatedANALIANCT02903888
A Cross-sectional, Observational Multicenter Study to Assess the Reasons for Choosing the 3-year Hormonal IUD and Level of IUDs Knowledge Among Women Aged 18 to 29 Years
An observational study of Intrauterine Devices, Medicated, run by Bayer at 1 site in Spain.
Trial summary
A cross-sectional, observational multicenter study to assess the reasons for choosing the 3-year hormonal IUD and level of IUDs knowledge among women aged 18 to 29 years. The study will be conducted in standard clinical practice conditions at public and private gynecology clinics and during a single study visit. Read more about this study
- Who is it for?
- Ages 18 to 29 years, women only
- Conditions the study is for
- Intrauterine Devices, Medicated
- What is being tested?
- Levonorgestrel (Jaydess, Skyla, BAY86-5028)
- How many people
- 886 participants
- Where
- 1 siteSpain
- Study dates
- 8 Sep 2016to 23 Dec 2017
- 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 29 years
- Women only
- No healthy volunteers
- Adult
Study population: The study population will consist of women aged 18-29 years, who have freely chosen Jaydess for contraception after being adequately counseled and informed of all contraceptive options by their physician at a previous visit to the study visit in a routine clinical practice setting
Who may be able to join
- Women aged 18 to 29 years.
- Women who decided to initiate treatment with a 3-year hormonal IUD for contraception after being adequately counseled and informed of all contraceptive options by their physician during a routine clinical visit, prior to the study visit (insertion visit).
- Women capable of reading and writing.
- Women who signed informed consent.
Who cannot join
- Women currently participating in an interventional clinical trial.
- Prescription of the 3-year hormonal IUD for non-contraceptive medical reasons.
Trial locations and contacts
1 site in 1 country.
About this study
A cross-sectional, observational multicenter study to assess the reasons for choosing the 3-year hormonal IUD and level of IUDs knowledge among women aged 18 to 29 years. The study will be conducted in standard clinical practice conditions at public and private gynecology clinics and during a single study visit.
Approximately 1,000 women aged 18 to 29 years who have freely chosen the 3 year hormonal IUD as their contraceptive method will be included in the study.
- Conditions
- Intrauterine Devices, Medicated
- Being tested
- Levonorgestrel (Jaydess, Skyla, BAY86-5028)
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
Intrauterine delivery system Jaydess (13.5 mg levonorgestrel)
| Study group | Role | What they receive |
|---|---|---|
| BAY86-5028 | Women aged 18 to 29 years that use Jaydess for contraception Receives: Drug: Levonorgestrel (Jaydess, Skyla, BAY86-5028) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reason for choosing Jaydess as intrauterine device (IUD)
The participants select the reason out of a given list of 15 possible reasons
Measured: day 1
Reason for switching to Jaydess if used another type of intrauterine device before
The participants select the reason out of a given list of 10 possible reasons
Measured: day 1
Knowledge of Jaydess or other IUDs prior to the visit
The participants select the reason out of a given list of 3 possible reasons
Measured: day 1
Is the first intrauterine device prescribed?
Possible reasons: Yes or No
Measured: day 1
Person who encouraged the use of jaydess?
The participants select the answer out of a given list of 5 possible people
Measured: day 1
Secondary outcomes (23)
Reason for not using Jaydess or other intrauterine delivery system (IUD) before
The participants select the reason out of a given list of 12 possible reasons
Measured: day 1
Uterine length as measured by ultrasonography
Measured: day 1
Presence of dysmenorrhea (Y/N)
Measured: day 1
Current contraception method
The participants select out of a given list of 20 options
Measured: day 1
Date of birth
Measured: day 1
Marital status
Measured: day 1
Place of birth
Measured: day 1
Place of residence
Measured: day 1
Educational level
Measured: day 1
Employment
Measured: day 1
Income level
Measured: day 1
Do you have children? (Y/N)
Measured: day 1
Number of children
Measured: day 1
Has she had some birth vaginally? (Y/N)
Measured: day 1
Date of last birth
Measured: day 1
Do you plan to have (more) children? (Yes/No/Unknown)
Measured: day 1
When she plans to have (more) children
Measured: day 1
Frequency of menstrual bleeding
Measured: day 1
Regularity of menstrual bleeding
Measured: day 1
Quantity of menstrual bleeding
Measured: day 1
Duration of menstrual bleeding
Measured: day 1
Absence of menstrual bleeding
Measured: day 1
Questionnaire concerning the physicians' characteristics
The questionnaire consists of 7 questions
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2016 (estimated)
- Study start8 Sep 2016
- Primary completion30 Oct 2017
- Study completion23 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrauterine Devices, MedicatedStudies 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
- Cross-sectional
- Enrolment
- 886 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02903888
- Sponsor's protocol ID
- 18883
- Acronym
- ANALIA
- Status last verified
- Jan 2018
- First submitted
- 13 Sep 2016
- Last updated
- 12 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross-sectional, Observational Multicenter Study to Assess the Reasons for Choosing the 3-year Hormonal IUD and Level of IUDs Knowledge Among Women Aged 18 to 29 Years
- ClinicalTrials.gov ID
- NCT02903888
- Acronym / sponsor ID
- ANALIA / 18883
- Conditions
- Intrauterine Devices, Medicated
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 886 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 8 Sep 2016 (actual)
- Primary completion
- 30 Oct 2017 (actual)
- Study completion
- 23 Dec 2017 (actual)
- First posted
- 16 Sep 2016 (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.
A cross-sectional, observational multicenter study to assess the reasons for choosing the 3-year hormonal IUD and level of IUDs knowledge among women aged 18 to 29 years. The study will be conducted in standard clinical practice conditions at public and private gynecology clinics and during a single study visit.
Approximately 1,000 women aged 18 to 29 years who have freely chosen the 3 year hormonal IUD as their contraceptive method will be included in the study.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BAY86-5028 | – | Drug: Levonorgestrel (Jaydess, Skyla, BAY86-5028)Women aged 18 to 29 years that use Jaydess for contraception |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study population will consist of women aged 18-29 years, who have freely chosen Jaydess for contraception after being adequately counseled and informed of all contraceptive options by their physician at a previous visit to the study visit in a routine clinical practice setting
Key inclusion criteria (4 listed)
- Women aged 18 to 29 years.
- Women who decided to initiate treatment with a 3-year hormonal IUD for contraception after being adequately counseled and informed of all contraceptive options by their physician during a routine clinical visit, prior to the study visit (insertion visit).
- Women capable of reading and writing.
- Women who signed informed consent.
Key exclusion criteria (2 listed)
- Women currently participating in an interventional clinical trial.
- Prescription of the 3-year hormonal IUD for non-contraceptive medical reasons.
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)Intrauterine delivery system Jaydess (13.5 mg levonorgestrel) | Drug | BAY86-5028 |
Primary outcome
Reason for choosing Jaydess as intrauterine device (IUD)
Time frame: day 1
The participants select the reason out of a given list of 15 possible reasons
Reason for switching to Jaydess if used another type of intrauterine device before
Time frame: day 1
The participants select the reason out of a given list of 10 possible reasons
Knowledge of Jaydess or other IUDs prior to the visit
Time frame: day 1
The participants select the reason out of a given list of 3 possible reasons
Is the first intrauterine device prescribed?
Time frame: day 1
Possible reasons: Yes or No
Person who encouraged the use of jaydess?
Time frame: day 1
The participants select the answer out of a given list of 5 possible people
23 secondary outcomes
Reason for not using Jaydess or other intrauterine delivery system (IUD) before
Time frame: day 1
Uterine length as measured by ultrasonography
Time frame: day 1
Presence of dysmenorrhea (Y/N)
Time frame: day 1
Current contraception method
Time frame: day 1
Date of birth
Time frame: day 1
Marital status
Time frame: day 1
Place of birth
Time frame: day 1
Place of residence
Time frame: day 1
Educational level
Time frame: day 1
Employment
Time frame: day 1
Income level
Time frame: day 1
Do you have children? (Y/N)
Time frame: day 1
Number of children
Time frame: day 1
Has she had some birth vaginally? (Y/N)
Time frame: day 1
Date of last birth
Time frame: day 1
Do you plan to have (more) children? (Yes/No/Unknown)
Time frame: day 1
When she plans to have (more) children
Time frame: day 1
Frequency of menstrual bleeding
Time frame: day 1
Regularity of menstrual bleeding
Time frame: day 1
Quantity of menstrual bleeding
Time frame: day 1
Duration of menstrual bleeding
Time frame: day 1
Absence of menstrual bleeding
Time frame: day 1
Questionnaire concerning the physicians' characteristics
Time frame: day 1
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 12 Jan 2018.
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Recruiting
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Eumenorrhea, Intrauterine Devices, Medicated
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 Intrauterine Devices, Medicated, run by Bayer at 1 site in Spain.
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 4 inclusion and 2 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 12 Jan 2018. 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 Spain. 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?
Reason for choosing Jaydess as intrauterine device (IUD) (time frame: day 1). The study lists 5 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 12 Jan 2018.