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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levonorgestrel (Jaydess, BAY86-5028) | women aged 18 to 29 years following 6 (±1) months of Jaydess® use as their contraceptive method. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levonorgestrel (Jaydess, BAY86-5028) | Drug | Intrauterine delivery system Jaydess (13.5 mg levonorgestrel) |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Age (years) | At the single visit | |
| Marital Status | At the single visit | |
| Place of Birth |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many Locations | Spain |
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| 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 |
| ID | Term |
|---|---|
| D016912 | Levonorgestrel |
| ID | Term |
|---|---|
| D009644 | Norgestrel |
| D009652 | Norpregnenes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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