check_circleStudy Completed

Quality of Life

Bayer Identifier:

18096

ClinicalTrials.gov Identifier:

NCT02574715

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.

Key Participants Requirements

Sex

Female

Age

18 - 29 Years
  • - 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.


  • - 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
1039
Trial Dates
September 2015 - September 2016
Phase
N/A
Could I Receive a placebo
No
Products
Skyla (Levonorgestrel, BAY86-5028)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many locations, Spain

Primary Outcome

  • 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.
    date_rangeTime Frame:
    At the single visit
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Age (years)
    date_rangeTime Frame:
    At the single visit
    enhanced_encryption
    Safety Issue:
    No
  • Marital Status
    date_rangeTime Frame:
    At the single visit
    enhanced_encryption
    Safety Issue:
    No
  • Place of Birth
    date_rangeTime Frame:
    At the single visit
    enhanced_encryption
    Safety Issue:
    No
  • Place of residence (province, town, city or rural area)
    date_rangeTime Frame:
    At the single visit
    enhanced_encryption
    Safety Issue:
    No
  • Educational level (primary, secondary or higher education)
    date_rangeTime Frame:
    At the single visit
    enhanced_encryption
    Safety Issue:
    No
  • Employment (working outside the home, working from home, unemployed, student)
    date_rangeTime Frame:
    At the single visit
    enhanced_encryption
    Safety Issue:
    No
  • Maternity status (has children or plans to have children)
    date_rangeTime Frame:
    At the single visit
    enhanced_encryption
    Safety Issue:
    No
  • Frequency attending this physician’s clinic for family planning purposes
    date_rangeTime Frame:
    At the single visit
    enhanced_encryption
    Safety Issue:
    No
  • History of type of contraceptive use
    date_rangeTime Frame:
    At the single visit
    enhanced_encryption
    Safety Issue:
    No
  • History of duration of contraceptive use
    date_rangeTime Frame:
    At the single visit
    enhanced_encryption
    Safety Issue:
    No
  • Prescription of Jaydess (date)
    date_rangeTime Frame:
    At the single visit
    enhanced_encryption
    Safety Issue:
    No
  • 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 visit
    enhanced_encryption
    Safety Issue:
    No
  • Global assessment of the insertion by means of a structured interview for pain questions (any, slight, moderate, severe)
    date_rangeTime Frame:
    At the single visit
    enhanced_encryption
    Safety Issue:
    No
  • Global assessment of the insertion by means of a structured interview for times questions
    date_rangeTime Frame:
    At the single visit
    enhanced_encryption
    Safety Issue:
    No
  • 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 visit
    enhanced_encryption
    Safety Issue:
    No
  • 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).
    date_rangeTime Frame:
    At the single visit
    enhanced_encryption
    Safety Issue:
    No
  • Bleeding pattern features, using a questionnaire to compare current bleeding versus bleeding before the insertion of Jaydess as recalled
    date_rangeTime Frame:
    At the single visit
    enhanced_encryption
    Safety Issue:
    No

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
N/A

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here to find results for studies related to Bayer products.