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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Intrauterine Devices, Medicated

Intervention / Treatment
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* Drug: Levonorgestrel (Jaydess, Skyla, BAY86-5028)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 29 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| BAY86-5028<br>Women aged 18 to 29 years that use Jaydess for contraception | Drug: Levonorgestrel (Jaydess, Skyla, BAY86-5028)<br>* Intrauterine delivery system Jaydess (13.5 mg levonorgestrel)<br>|

What is the study measuring?
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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 |