Trial Condition(s):
Intrauterine Devices, Medicated
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)
Bayer Identifier:
18883
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
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.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site Many locations, Spain | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Trial Design
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
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Reason for choosing Jaydess as intrauterine device (IUD)The participants select the reason out of a given list of 15 possible reasonsTimeframe: day 1
- Reason for switching to Jaydess if used another type of intrauterine device beforeThe participants select the reason out of a given list of 10 possible reasonsTimeframe: day 1
- Knowledge of Jaydess or other IUDs prior to the visitThe participants select the reason out of a given list of 3 possible reasonsTimeframe: day 1
- Is the first intrauterine device prescribed?Possible reasons: Yes or NoTimeframe: day 1
- Person who encouraged the use of jaydess?The participants select the answer out of a given list of 5 possible peopleTimeframe: day 1
Secondary Outcome
- Reason for not using Jaydess or other intrauterine delivery system (IUD) beforeThe participants select the reason out of a given list of 12 possible reasonsTimeframe: day 1
- Uterine length as measured by ultrasonographyTimeframe: day 1
- Presence of dysmenorrhea (Y/N)Timeframe: day 1
- Current contraception methodThe participants select out of a given list of 20 optionsTimeframe: day 1
- Date of birthTimeframe: day 1
- Marital statusTimeframe: day 1
- Place of birthTimeframe: day 1
- Place of residenceTimeframe: day 1
- Educational levelTimeframe: day 1
- EmploymentTimeframe: day 1
- Income levelTimeframe: day 1
- Do you have children? (Y/N)Timeframe: day 1
- Number of childrenTimeframe: day 1
- Has she had some birth vaginally? (Y/N)Timeframe: day 1
- Date of last birthTimeframe: day 1
- Do you plan to have (more) children? (Yes/No/Unknown)Timeframe: day 1
- When she plans to have (more) childrenTimeframe: day 1
- Frequency of menstrual bleedingTimeframe: day 1
- Regularity of menstrual bleedingTimeframe: day 1
- Quantity of menstrual bleedingTimeframe: day 1
- Duration of menstrual bleedingTimeframe: day 1
- Absence of menstrual bleedingTimeframe: day 1
- Questionnaire concerning the physicians' characteristicsThe questionnaire consists of 7 questionsTimeframe: day 1
Additional Information
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