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

NCT02574715 | Completed

• 1 other identifier: 18096
• Study Type: observational
• Target: 1,039
• Locations: 1 country
• Sites: 1

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.

Conditions

Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• 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

Study Arms (1)

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)

Interventions

Levonorgestrel (Jaydess, BAY86-5028) DRUG

Intrauterine delivery system Jaydess (13.5 mg levonorgestrel)

Levonorgestrel (Jaydess, BAY86-5028)

Eligibility Criteria

• Age: 18 Years - 29 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Many Locations, Spain

Location

MeSH Terms

Interventions

Levonorgestrel

Intervention Hierarchy (Ancestors)

Norgestrel; Norpregnenes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2015
• First Posted: October 14, 2015
• Study Start: September 18, 2015
• Primary Completion: July 1, 2016
• Study Completion: September 28, 2016
• Last Updated: June 29, 2017

Record last verified: 2017-06

Locations

ES (1)