Trial Condition(s):
Quality of Life
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 (JULIA)
Bayer Identifier:
18096
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.
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.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Many locations, Spain | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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.
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
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.Timeframe: At the single visit
Secondary Outcome
- Age (years)Timeframe: At the single visit
- Marital StatusTimeframe: At the single visit
- Place of BirthTimeframe: At the single visit
- Place of residence (province, town, city or rural area)Timeframe: At the single visit
- Educational level (primary, secondary or higher education)Timeframe: At the single visit
- Employment (working outside the home, working from home, unemployed, student)Timeframe: At the single visit
- Maternity status (has children or plans to have children)Timeframe: At the single visit
- Frequency attending this physician’s clinic for family planning purposesTimeframe: At the single visit
- History of type of contraceptive useTimeframe: At the single visit
- History of duration of contraceptive useTimeframe: At the single visit
- Prescription of Jaydess (date)Timeframe: 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.Timeframe: At the single visit
- Global assessment of the insertion by means of a structured interview for pain questions (any, slight, moderate, severe)Timeframe: At the single visit
- Global assessment of the insertion by means of a structured interview for times questionsTimeframe: 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)Timeframe: At the single visit
- 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).Timeframe: At the single visit
- Bleeding pattern features, using a questionnaire to compare current bleeding versus bleeding before the insertion of Jaydess as recalledTimeframe: At the single visit
Additional Information
Copyright © Bayer
Powered by
