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.

Bayer0 sites1,039 target enrollmentSeptember 18, 2015

ConditionsQuality of Life

InterventionsLevonorgestrel (Jaydess, BAY86-5028)

DrugsLevonorgestrel (Jaydess, BAY86-5028)

Overview

Phase: Not Applicable
Intervention: Levonorgestrel (Jaydess, BAY86-5028)
Conditions: Quality of Life
Sponsor: Bayer
Enrollment: 1039
Primary Endpoint: Quality of life as determined using the SEC-QoL scale
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 18, 2015

End Date

September 28, 2016

Last Updated

8 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

Bayer

Responsible Party

Sponsor

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.

Arms & Interventions

Levonorgestrel (Jaydess, BAY86-5028)

women aged 18 to 29 years following 6 (±1) months of Jaydess® use as their contraceptive method.

Intervention: Levonorgestrel (Jaydess, BAY86-5028)

Outcomes

Primary Outcomes

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

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