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

Completed

• Conditions: Intrauterine Devices, Medicated
• Interventions: Drug: Levonorgestrel (Jaydess, Skyla, BAY86-5028)

• Registration Number: NCT02903888
• Lead Sponsor: Bayer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-08
• Study First Submitted: 2016-09-13
• Study First Submitted QC: 2016-09-15
• Study First Posted: 2016-09-16
• Primary Completion: 2017-10-30
• Study Completion: 2017-12-23
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-10
• Last Update Posted: 2018-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 886

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
BAY86-5028	Levonorgestrel (Jaydess, Skyla, BAY86-5028)	Women aged 18 to 29 years that use Jaydess for contraception

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Reason for not using Jaydess or other intrauterine delivery system (IUD) before	day 1	The participants select the reason out of a given list of 12 possible reasons
Uterine length as measured by ultrasonography	day 1
Presence of dysmenorrhea (Y/N)	day 1
Current contraception method	day 1	The participants select out of a given list of 20 options
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
Frequency of menstrual bleeding	day 1
Absence of menstrual bleeding	day 1
When she plans to have (more) children	day 1
Regularity of menstrual bleeding	day 1
Quantity of menstrual bleeding	day 1
Duration of menstrual bleeding	day 1
Questionnaire concerning the physicians' characteristics	day 1	The questionnaire consists of 7 questions