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Completed

NCT Number: NCT02574715

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

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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Key information

Conditions

Quality of Life

Age range

18 year–29 year

Sex eligibility

Female

Study type

Observational

Primary location

Many Locations, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Levonorgestrel (Jaydess, BAY86-5028)

Drug

Intrauterine delivery system Jaydess (13.5 mg levonorgestrel)

Primary outcomes

  1. Quality of life as determined using the SEC-QoL scale

    Time frame: At the single visit

    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.

Secondary outcomes

  1. Age (years)

    Time frame: At the single visit

  2. Marital Status

    Time frame: At the single visit

  3. Place of Birth

    Time frame: At the single visit

  4. Place of residence (province, town, city or rural area)

    Time frame: At the single visit

  5. Educational level (primary, secondary or higher education)

    Time frame: At the single visit

  6. Employment (working outside the home, working from home, unemployed, student)

    Time frame: At the single visit

  7. Maternity status (has children or plans to have children)

    Time frame: At the single visit

  8. Frequency attending this physician's clinic for family planning purposes

    Time frame: At the single visit

  9. History of type of contraceptive use

    Time frame: At the single visit

  10. History of duration of contraceptive use

    Time frame: At the single visit

  11. Prescription of Jaydess (date)

    Time frame: At the single visit

  12. Benefits perceived on ease and comfort of use by means of a structured interview (Yes, No)

    Time frame: At the single visit

    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.

  13. Global assessment of the insertion by means of a structured interview for pain questions (any, slight, moderate, severe)

    Time frame: At the single visit

  14. Global assessment of the insertion by means of a structured interview for times questions

    Time frame: At the single visit

  15. 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

  16. Global satisfaction with Jaydess, using a structured questionaire

    Time frame: At the single visit

    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).

  17. 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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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.

Acronym: JULIA

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 14, 2015
Registry last updated
Jun 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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