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 (JULIA)

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.

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life
• Intervention / Treatment: Drug: Levonorgestrel (Jaydess, BAY86-5028)

• Study Type: Observational
• Enrollment (Actual): 1039

Contacts and Locations

Study Locations

• Spain
  • Many locations, Spain

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 29 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Levonorgestrel (Jaydess, BAY86-5028); women aged 18 to 29 years following 6 (±1) months of Jaydess® use as their contraceptive method.	Drug: Levonorgestrel (Jaydess, BAY86-5028); Intrauterine delivery system Jaydess (13.5 mg levonorgestrel)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age (years)		At the single visit
Marital Status		At the single visit
Place of Birth		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
Employment (working outside the home, working from home, unemployed, student)		At the single visit
Maternity status (has children or plans to have children)		At the single visit
Frequency attending this physician's clinic for family planning purposes		At the single visit
History of type of contraceptive use		At the single visit
History of duration of contraceptive use		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)	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
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 by means of a structured interview for times questions		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
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
Bleeding pattern features, using a questionnaire to compare current bleeding versus bleeding before the insertion of Jaydess as recalled		At the single visit

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2015
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): September 28, 2016

Study Registration Dates

• First Submitted: September 21, 2015
• First Submitted That Met QC Criteria: October 10, 2015
• First Posted (Estimate): October 14, 2015

Study Record Updates

• Last Update Posted (Actual): June 29, 2017
• Last Update Submitted That Met QC Criteria: June 28, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Levonorgestrel
• Other Study ID Numbers: 18096 (Other Grant/Funding Number: Medical Scientific Fund of the Mayor of Vienna)