Overview

This trial has been completed.

Condition quality of life
Treatment levonorgestrel (jaydess, bay86-5028)
Sponsor Bayer
Start date September 2015
End date July 2016
Trial size 1039 participants
Trial identifier NCT02574715, 18096

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective cross-sectional
Arm
women aged 18 to 29 years following 6 (±1) months of Jaydess® use as their contraceptive method.
levonorgestrel (jaydess, bay86-5028)
Intrauterine delivery system Jaydess (13.5 mg levonorgestrel)

Primary Outcomes

Measure
Quality of life as determined using the SEC-QoL scale
time frame: At the single visit

Secondary Outcomes

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

Eligibility Criteria

Female participants from 18 years up to 29 years old.

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.

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Bayer.