check_circleStudy Completed
Intrauterine Devices, Medicated
Bayer Identifier:
18883
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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 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.
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.
Key Participants Requirements
Sex
FemaleAge
18 - 29 YearsTrial summary
Enrollment Goal
886Trial Dates
September 2016 - December 2017Phase
Phase 4Could I Receive a placebo
NoProducts
Skyla (Levonorgestrel, BAY86-5028)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many locations, Spain |
Primary Outcome
- Reason for choosing Jaydess as intrauterine device (IUD)The participants select the reason out of a given list of 15 possible reasonsdate_rangeTime Frame:day 1enhanced_encryptionNoSafety Issue:
- 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 reasonsdate_rangeTime Frame:day 1enhanced_encryptionNoSafety Issue:
- Knowledge of Jaydess or other IUDs prior to the visitThe participants select the reason out of a given list of 3 possible reasonsdate_rangeTime Frame:day 1enhanced_encryptionNoSafety Issue:
- Is the first intrauterine device prescribed?Possible reasons: Yes or Nodate_rangeTime Frame:day 1enhanced_encryptionNoSafety Issue:
- Person who encouraged the use of jaydess?The participants select the answer out of a given list of 5 possible peopledate_rangeTime Frame:day 1enhanced_encryptionNoSafety Issue:
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 reasonsdate_rangeTime Frame:day 1enhanced_encryptionNoSafety Issue:
- Uterine length as measured by ultrasonographydate_rangeTime Frame:day 1enhanced_encryptionNoSafety Issue:
- Presence of dysmenorrhea (Y/N)date_rangeTime Frame:day 1enhanced_encryptionNoSafety Issue:
- Current contraception methodThe participants select out of a given list of 20 optionsdate_rangeTime Frame:day 1enhanced_encryptionNoSafety Issue:
- Date of birthdate_rangeTime Frame:day 1enhanced_encryptionNoSafety Issue:
- Marital statusdate_rangeTime Frame:day 1enhanced_encryptionNoSafety Issue:
- Place of birthdate_rangeTime Frame:day 1enhanced_encryptionNoSafety Issue:
- Place of residencedate_rangeTime Frame:day 1enhanced_encryptionNoSafety Issue:
- Educational leveldate_rangeTime Frame:day 1enhanced_encryptionNoSafety Issue:
- Employmentdate_rangeTime Frame:day 1enhanced_encryptionNoSafety Issue:
- Income leveldate_rangeTime Frame:day 1enhanced_encryptionNoSafety Issue:
- Do you have children? (Y/N)date_rangeTime Frame:day 1enhanced_encryptionNoSafety Issue:
- Number of childrendate_rangeTime Frame:day 1enhanced_encryptionNoSafety Issue:
- Has she had some birth vaginally? (Y/N)date_rangeTime Frame:day 1enhanced_encryptionNoSafety Issue:
- Date of last birthdate_rangeTime Frame:day 1enhanced_encryptionNoSafety Issue:
- Do you plan to have (more) children? (Yes/No/Unknown)date_rangeTime Frame:day 1enhanced_encryptionNoSafety Issue:
- When she plans to have (more) childrendate_rangeTime Frame:day 1enhanced_encryptionNoSafety Issue:
- Frequency of menstrual bleedingdate_rangeTime Frame:day 1enhanced_encryptionNoSafety Issue:
- Regularity of menstrual bleedingdate_rangeTime Frame:day 1enhanced_encryptionNoSafety Issue:
- Quantity of menstrual bleedingdate_rangeTime Frame:day 1enhanced_encryptionNoSafety Issue:
- Duration of menstrual bleedingdate_rangeTime Frame:day 1enhanced_encryptionNoSafety Issue:
- Absence of menstrual bleedingdate_rangeTime Frame:day 1enhanced_encryptionNoSafety Issue:
- Questionnaire concerning the physicians' characteristicsThe questionnaire consists of 7 questionsdate_rangeTime Frame:day 1enhanced_encryptionNoSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A