Clinical trial 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
Official 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Quality of Life
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2015-10-14
Enrollment: 1039
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Quality of life as determined using the SEC-QoL scale
timeFrame: At the single visit
Secondary outcomes:
measure: Age (years)
timeFrame: At the single visit
measure: Marital Status
timeFrame: At the single visit
measure: Place of Birth
timeFrame: At the single visit
measure: Place of residence (province, town, city or rural area)
timeFrame: At the single visit
measure: Educational level (primary, secondary or higher education)
timeFrame: At the single visit
measure: Employment (working outside the home, working from home, unemployed, student)
timeFrame: At the single visit
measure: Maternity status (has children or plans to have children)
timeFrame: At the single visit
measure: Frequency attending this physician's clinic for family planning purposes
timeFrame: At the single visit
measure: History of type of contraceptive use
timeFrame: At the single visit
measure: History of duration of contraceptive use
timeFrame: At the single visit
measure: Prescription of Jaydess (date)
timeFrame: At the single visit
measure: Benefits perceived on ease and comfort of use by means of a structured interview (Yes, No)
timeFrame: At the single visit
measure: Global assessment of the insertion by means of a structured interview for pain questions (any, slight, moderate, severe)
timeFrame: At the single visit
measure: Global assessment of the insertion by means of a structured interview for times questions
timeFrame: At the single visit
measure: 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
measure: Global satisfaction with Jaydess, using a structured questionaire
timeFrame: At the single visit
measure: Bleeding pattern features, using a questionnaire to compare current bleeding versus bleeding before the insertion of Jaydess as recalled
timeFrame: At the single visit
Other outcomes:
Locations:
city: Many locations
country: Spain
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: