A Cross-sectional, Observational Multicenter Study to Assess the Reasons for Choosing the 3-year Hormonal IUD and Level of IUDs Knowledge Among Women Aged 18 to 29 Years (ANALIA)

A cross-sectional, observational multicenter study to assess the reasons for choosing the 3-year hormonal IUD and level of IUDs knowledge among women aged 18 to 29 years. The study will be conducted in standard clinical practice conditions at public and private gynecology clinics and during a single study visit.

Approximately 1,000 women aged 18 to 29 years who have freely chosen the 3 year hormonal IUD as their contraceptive method will be included in the study.

Study Overview

• Status: Completed
• Conditions: Intrauterine Devices, Medicated
• Intervention / Treatment: Drug: Levonorgestrel (Jaydess, Skyla, BAY86-5028)

• Study Type: Observational
• Enrollment (Actual): 886

Contacts and Locations

Study Locations

• Spain
  • Multiple Locations, Spain

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 25 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of women aged 18-29 years, who have freely chosen Jaydess for contraception after being adequately counseled and informed of all contraceptive options by their physician at a previous visit to the study visit in a routine clinical practice setting

Description

Inclusion Criteria:

• Women aged 18 to 29 years.
• Women who decided to initiate treatment with a 3-year hormonal IUD for contraception after being adequately counseled and informed of all contraceptive options by their physician during a routine clinical visit, prior to the study visit (insertion visit).
• Women capable of reading and writing.
• Women who signed informed consent.

Exclusion Criteria:

• Women currently participating in an interventional clinical trial.
• Prescription of the 3-year hormonal IUD for non-contraceptive medical reasons.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
BAY86-5028; Women aged 18 to 29 years that use Jaydess for contraception	Drug: Levonorgestrel (Jaydess, Skyla, BAY86-5028); Intrauterine delivery system Jaydess (13.5 mg levonorgestrel)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reason for choosing Jaydess as intrauterine device (IUD)	The participants select the reason out of a given list of 15 possible reasons	day 1
Reason for switching to Jaydess if used another type of intrauterine device before	The participants select the reason out of a given list of 10 possible reasons	day 1
Knowledge of Jaydess or other IUDs prior to the visit	The participants select the reason out of a given list of 3 possible reasons	day 1
Is the first intrauterine device prescribed?	Possible reasons: Yes or No	day 1
Person who encouraged the use of jaydess?	The participants select the answer out of a given list of 5 possible people	day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reason for not using Jaydess or other intrauterine delivery system (IUD) before	The participants select the reason out of a given list of 12 possible reasons	day 1
Uterine length as measured by ultrasonography		day 1
Presence of dysmenorrhea (Y/N)		day 1
Current contraception method	The participants select out of a given list of 20 options	day 1
Date of birth		day 1
Marital status		day 1
Place of birth		day 1
Place of residence		day 1
Educational level		day 1
Employment		day 1
Income level		day 1
Do you have children? (Y/N)		day 1
Number of children		day 1
Has she had some birth vaginally? (Y/N)		day 1
Date of last birth		day 1
Do you plan to have (more) children? (Yes/No/Unknown)		day 1
When she plans to have (more) children		day 1
Frequency of menstrual bleeding		day 1
Regularity of menstrual bleeding		day 1
Quantity of menstrual bleeding		day 1
Duration of menstrual bleeding		day 1
Absence of menstrual bleeding		day 1
Questionnaire concerning the physicians' characteristics	The questionnaire consists of 7 questions	day 1

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2016
• Primary Completion (Actual): October 30, 2017
• Study Completion (Actual): December 23, 2017

Study Registration Dates

• First Submitted: September 13, 2016
• First Submitted That Met QC Criteria: September 15, 2016
• First Posted (Estimate): September 16, 2016

Study Record Updates

• Last Update Posted (Actual): January 12, 2018
• Last Update Submitted That Met QC Criteria: January 10, 2018
• Last Verified: January 1, 2018

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: 18883