Quality of LifeJULIANCT02574715
An Observational Study to Assess Quality of Life and Satisfaction of Young Women (Aged 18-29) Following 6 (±1) Months Using Jaydess as Their Contraceptive Method
An observational study of Quality of Life, run by Bayer at 1 site in Spain.
Trial summary
This is a cross-sectional, multicenter observational study to assess quality of life in young Spanish women (aged 18 to 29) who use Jaydess® as their contraceptive method. The study will be conducted in standard clinical practice conditions at the 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
- Quality of Life
- What is being tested?
- Levonorgestrel (Jaydess, BAY86-5028)
- How many people
- 1,039 participants
- Where
- 1 siteSpain
- Study dates
- 18 Sep 2015to 28 Sep 2016
- 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: A total of 1,200 women aged 18 to 29 will be consecutively included in this study as they present at private gynecology clinics. Subjects must have been using the Jaydess intrauterine delivery system as their contraceptive of choice for a period of 6 (±1) months. The study population may be stratified into subsets to assess and identify differences in the subjects' quality of life, social and demographic characteristics, contraception characteristics, satisfaction, perceived benefits of Jaydess and bleeding pattern features.
Who may be able to join
- Women aged 18 to 29 years.
- Women who have been using Jaydess as their contraceptive method for 6 (±1) months.
- Women who have no comprehension, reading or writing challenges.
- Women who have given informed consent in writing.
Who cannot join
- Contraindication to the use of Jaydess.
- Prescription of Jaydess® for non-contraceptive medical reasons.
- Women who are considered to be unsuitable to take part in the study by the investigator (e.g., poor understanding of the study characteristics, uncooperative, etc.).
- Women who are currently taking part in any clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Cross-sectional, Observational Study to Assess Quality of Life and Satisfaction of Young Women (Aged 18-29) Following 6 (±1) Months Using Jaydess® as Their Contraceptive Method - The JULIA Study.
This is a cross-sectional, multicenter observational study to assess quality of life in young Spanish women (aged 18 to 29) who use Jaydess® as their contraceptive method. The study will be conducted in standard clinical practice conditions at the private gynecology clinics and during a single study visit.
Approximately 1,200 women who have been using the intrauterine delivery system (IUS) Jaydess® as their contraceptive method of choice for 6 (±1) months will be included in the study.
- Conditions
- Quality of Life
- Being tested
- Levonorgestrel (Jaydess, BAY86-5028)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levonorgestrel (Jaydess, BAY86-5028)Drug
Intrauterine delivery system Jaydess (13.5 mg levonorgestrel)
| Study group | Role | What they receive |
|---|---|---|
| Levonorgestrel (Jaydess, BAY86-5028) | women aged 18 to 29 years following 6 (±1) months of Jaydess® use as their contraceptive method. Receives: Drug: Levonorgestrel (Jaydess, BAY86-5028) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life as determined using the SEC-QoL scale
SEC-QoL (Spanish Contraception Society Quality of Life Questionnaire) is to assess the impact of contraceptive methods on health-related quality of life in women.
Measured: At the single visit
Secondary outcomes (17)
Age (years)
Measured: At the single visit
Marital Status
Measured: At the single visit
Place of Birth
Measured: At the single visit
Place of residence (province, town, city or rural area)
Measured: At the single visit
Educational level (primary, secondary or higher education)
Measured: At the single visit
Employment (working outside the home, working from home, unemployed, student)
Measured: At the single visit
Maternity status (has children or plans to have children)
Measured: At the single visit
Frequency attending this physician's clinic for family planning purposes
Measured: At the single visit
History of type of contraceptive use
Measured: At the single visit
History of duration of contraceptive use
Measured: At the single visit
Prescription of Jaydess (date)
Measured: At the single visit
Benefits perceived on ease and comfort of use by means of a structured interview (Yes, No)
This will be assessed by a structured interview during which the subject will be asked a number of questions by her gynecologist with answers (Yes or No): Indicate the advantages of Jaydess (select all that apply): comfort, avoid forgetfulness, reversibility, long duration, contraception cost, ease of use, safety, reduction in the duration and amount of bleeding, regulation of menstrual cycle, decreased menstrual pain, immediate contraceptive activity, high efficacy.
Measured: At the single visit
Global assessment of the insertion by means of a structured interview for pain questions (any, slight, moderate, severe)
Measured: At the single visit
Global assessment of the insertion by means of a structured interview for times questions
Measured: At the single visit
Global assessment of the insertion (acceptable without discomfort, with a few of minimal discomfort or with an enormous discomfort and unacceptable)
Measured: At the single visit
Global satisfaction with Jaydess, using a structured questionaire
Satisfaction with Jaydess will be assessed using a structured questionnaire. The ease of use and impact on activities of daily living dimensions will be assessed on 3 items (ease and comfort of use, impact on activities of daily living and sexuality) for each dimension, each one with a 5-item Likert-like scale (where 1 = extremely unsatisfied and 5 = extremely satisfied).
Measured: At the single visit
Bleeding pattern features, using a questionnaire to compare current bleeding versus bleeding before the insertion of Jaydess as recalled
Measured: At the single visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2015 (estimated)
- Study start18 Sep 2015
- Primary completion1 Jul 2016
- Study completion28 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies 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
- 1,039 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
- NCT02574715
- Sponsor's protocol ID
- 18096
- Acronym
- JULIA
- Status last verified
- Jun 2017
- First submitted
- 21 Sep 2015
- Last updated
- 29 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross-sectional, Observational Study to Assess Quality of Life and Satisfaction of Young Women (Aged 18-29) Following 6 (±1) Months Using Jaydess® as Their Contraceptive Method - The JULIA Study.
- ClinicalTrials.gov ID
- NCT02574715
- Acronym / sponsor ID
- JULIA / 18096
- Conditions
- Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,039 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 18 Sep 2015 (actual)
- Primary completion
- 1 Jul 2016 (actual)
- Study completion
- 28 Sep 2016 (actual)
- First posted
- 14 Oct 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.
This is a cross-sectional, multicenter observational study to assess quality of life in young Spanish women (aged 18 to 29) who use Jaydess® as their contraceptive method. The study will be conducted in standard clinical practice conditions at the private gynecology clinics and during a single study visit.
Approximately 1,200 women who have been using the intrauterine delivery system (IUS) Jaydess® as their contraceptive method of choice for 6 (±1) months will be included in the study.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Levonorgestrel (Jaydess, BAY86-5028) | – | Drug: Levonorgestrel (Jaydess, BAY86-5028)women aged 18 to 29 years following 6 (±1) months of Jaydess® use as their contraceptive method. |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- A total of 1,200 women aged 18 to 29 will be consecutively included in this study as they present at private gynecology clinics. Subjects must have been using the Jaydess intrauterine delivery system as their contraceptive of choice for a period of 6 (±1) months. The study population may be stratified into subsets to assess and identify differences in the subjects' quality of life, social and demographic characteristics, contraception characteristics, satisfaction, perceived benefits of Jaydess and bleeding pattern features.
Key inclusion criteria (4 listed)
- Women aged 18 to 29 years.
- Women who have been using Jaydess as their contraceptive method for 6 (±1) months.
- Women who have no comprehension, reading or writing challenges.
- Women who have given informed consent in writing.
Key exclusion criteria (4 listed)
- Contraindication to the use of Jaydess.
- Prescription of Jaydess® for non-contraceptive medical reasons.
- Women who are considered to be unsuitable to take part in the study by the investigator (e.g., poor understanding of the study characteristics, uncooperative, etc.).
- Women who are currently taking part in any clinical trial.
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, BAY86-5028)Intrauterine delivery system Jaydess (13.5 mg levonorgestrel) | Drug | Levonorgestrel (Jaydess, BAY86-5028) |
Primary outcome
Quality of life as determined using the SEC-QoL scale
Time frame: At the single visit
SEC-QoL (Spanish Contraception Society Quality of Life Questionnaire) is to assess the impact of contraceptive methods on health-related quality of life in women.
17 secondary outcomes
Age (years)
Time frame: At the single visit
Marital Status
Time frame: At the single visit
Place of Birth
Time frame: At the single visit
Place of residence (province, town, city or rural area)
Time frame: At the single visit
Educational level (primary, secondary or higher education)
Time frame: At the single visit
Employment (working outside the home, working from home, unemployed, student)
Time frame: At the single visit
Maternity status (has children or plans to have children)
Time frame: At the single visit
Frequency attending this physician's clinic for family planning purposes
Time frame: At the single visit
History of type of contraceptive use
Time frame: At the single visit
History of duration of contraceptive use
Time frame: At the single visit
Prescription of Jaydess (date)
Time frame: At the single visit
Benefits perceived on ease and comfort of use by means of a structured interview (Yes, No)
Time frame: At the single visit
Global assessment of the insertion by means of a structured interview for pain questions (any, slight, moderate, severe)
Time frame: At the single visit
Global assessment of the insertion by means of a structured interview for times questions
Time frame: At the single visit
Global assessment of the insertion (acceptable without discomfort, with a few of minimal discomfort or with an enormous discomfort and unacceptable)
Time frame: At the single visit
Global satisfaction with Jaydess, using a structured questionaire
Time frame: At the single visit
Bleeding pattern features, using a questionnaire to compare current bleeding versus bleeding before the insertion of Jaydess as recalled
Time frame: At the single visit
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 29 Jun 2017.
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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 Quality of Life, 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 4 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 29 Jun 2017. 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?
Quality of life as determined using the SEC-QoL scale (time frame: At the single visit). 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 29 Jun 2017.