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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Quality of Life

Intervention / Treatment
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* Drug: Levonorgestrel (Jaydess, BAY86-5028)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 29 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Levonorgestrel (Jaydess, BAY86-5028)<br>women aged 18 to 29 years following 6 (±1) months of Jaydess® use as their contraceptive method. | Drug: Levonorgestrel (Jaydess, BAY86-5028)<br>* Intrauterine delivery system Jaydess (13.5 mg levonorgestrel)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At the single visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Age (years) |  | At the single visit | 
| Marital Status |  | At the single visit | 
| Place of Birth |  | At the single visit | 
| Place of residence (province, town, city or rural area) |  | At the single visit | 
| Educational level (primary, secondary or higher education) |  | At the single visit | 
| Employment (working outside the home, working from home, unemployed, student) |  | At the single visit | 
| Maternity status (has children or plans to have children) |  | At the single visit | 
| Frequency attending this physician's clinic for family planning purposes |  | At the single visit | 
| History of type of contraceptive use |  | At the single visit | 
| History of duration of contraceptive use |  | At the single visit | 
| Prescription of Jaydess (date) |  | 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. | At the single visit | 
| Global assessment of the insertion by means of a structured interview for pain questions (any, slight, moderate, severe) |  | At the single visit | 
| Global assessment of the insertion by means of a structured interview for times questions |  | 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) |  | 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). | At the single visit | 
| Bleeding pattern features, using a questionnaire to compare current bleeding versus bleeding before the insertion of Jaydess as recalled |  | At the single visit |