check_circleStudy Completed
Quality of Life
Bayer Identifier:
18096
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
Trial purpose
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.
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.
Key Participants Requirements
Sex
FemaleAge
18 - 29 YearsTrial summary
Enrollment Goal
1039Trial Dates
September 2015 - September 2016Phase
N/ACould I Receive a placebo
NoProducts
Skyla (Levonorgestrel, BAY86-5028)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many locations, Spain |
Primary Outcome
- Quality of life as determined using the SEC-QoL scaleSEC-QoL (Spanish Contraception Society Quality of Life Questionnaire) is to assess the impact of contraceptive methods on health-related quality of life in women.date_rangeTime Frame:At the single visitenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Age (years)date_rangeTime Frame:At the single visitenhanced_encryptionNoSafety Issue:
- Marital Statusdate_rangeTime Frame:At the single visitenhanced_encryptionNoSafety Issue:
- Place of Birthdate_rangeTime Frame:At the single visitenhanced_encryptionNoSafety Issue:
- Place of residence (province, town, city or rural area)date_rangeTime Frame:At the single visitenhanced_encryptionNoSafety Issue:
- Educational level (primary, secondary or higher education)date_rangeTime Frame:At the single visitenhanced_encryptionNoSafety Issue:
- Employment (working outside the home, working from home, unemployed, student)date_rangeTime Frame:At the single visitenhanced_encryptionNoSafety Issue:
- Maternity status (has children or plans to have children)date_rangeTime Frame:At the single visitenhanced_encryptionNoSafety Issue:
- Frequency attending this physician’s clinic for family planning purposesdate_rangeTime Frame:At the single visitenhanced_encryptionNoSafety Issue:
- History of type of contraceptive usedate_rangeTime Frame:At the single visitenhanced_encryptionNoSafety Issue:
- History of duration of contraceptive usedate_rangeTime Frame:At the single visitenhanced_encryptionNoSafety Issue:
- Prescription of Jaydess (date)date_rangeTime Frame:At the single visitenhanced_encryptionNoSafety Issue:
- 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.date_rangeTime Frame:At the single visitenhanced_encryptionNoSafety Issue:
- Global assessment of the insertion by means of a structured interview for pain questions (any, slight, moderate, severe)date_rangeTime Frame:At the single visitenhanced_encryptionNoSafety Issue:
- Global assessment of the insertion by means of a structured interview for times questionsdate_rangeTime Frame:At the single visitenhanced_encryptionNoSafety Issue:
- Global assessment of the insertion (acceptable without discomfort, with a few of minimal discomfort or with an enormous discomfort and unacceptable)date_rangeTime Frame:At the single visitenhanced_encryptionNoSafety Issue:
- Global satisfaction with Jaydess, using a structured questionaireSatisfaction 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).date_rangeTime Frame:At the single visitenhanced_encryptionNoSafety Issue:
- Bleeding pattern features, using a questionnaire to compare current bleeding versus bleeding before the insertion of Jaydess as recalleddate_rangeTime Frame:At the single visitenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A