An observational study in Quality of Life, sponsored by Bayer. Completed at 1 site in Spain. Open to female participants aged 18 Years to 29 Years. Per ClinicalTrials.gov, last updated 2017-06-29.
Sponsored by Bayer · Observational
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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Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.
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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.
Exclusion Criteria:
women aged 18 to 29 years following 6 (±1) months of Jaydess® use as their contraceptive method.
Drug: Levonorgestrel (Jaydess, BAY86-5028)
Intrauterine delivery system Jaydess (13.5 mg levonorgestrel)
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.
Time frame: At the single visit
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)
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.
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
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).
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
This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
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