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

Quality of Life Clinical Trial

— JULIA  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02574715
• Other study ID #: 18096
• Status: Completed
• Phase: N/A
• First received: September 21, 2015
• Last updated: June 28, 2017
• Start date: September 18, 2015
• Est. completion date: September 28, 2016

Study information

• Verified date: June 2017
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1039
• Est. completion date: September 28, 2016
• Est. primary completion date: July 1, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 29 Years

Eligibility

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.

Related Conditions & MeSH terms

• Quality of Life

Intervention

Drug:
• Levonorgestrel (Jaydess, BAY86-5028)
Intrauterine delivery system Jaydess (13.5 mg levonorgestrel)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At the single visit
Secondary	Age (years)		At the single visit
Secondary	Marital Status		At the single visit
Secondary	Place of Birth		At the single visit
Secondary	Place of residence (province, town, city or rural area)		At the single visit
Secondary	Educational level (primary, secondary or higher education)		At the single visit
Secondary	Employment (working outside the home, working from home, unemployed, student)		At the single visit
Secondary	Maternity status (has children or plans to have children)		At the single visit
Secondary	Frequency attending this physician's clinic for family planning purposes		At the single visit
Secondary	History of type of contraceptive use		At the single visit
Secondary	History of duration of contraceptive use		At the single visit
Secondary	Prescription of Jaydess (date)		At the single visit
Secondary	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.	At the single visit
Secondary	Global assessment of the insertion by means of a structured interview for pain questions (any, slight, moderate, severe)		At the single visit
Secondary	Global assessment of the insertion by means of a structured interview for times questions		At the single visit
Secondary	Global assessment of the insertion (acceptable without discomfort, with a few of minimal discomfort or with an enormous discomfort and unacceptable)		At the single visit
Secondary	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).	At the single visit
Secondary	Bleeding pattern features, using a questionnaire to compare current bleeding versus bleeding before the insertion of Jaydess as recalled		At the single visit

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