check_circleStudy Completed

Intrauterine Devices, Medicated

Bayer Identifier:

18883

ClinicalTrials.gov Identifier:

NCT02903888

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.

Key Participants Requirements

Sex

Female

Age

18 - 29 Years
  • - 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.


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

Trial summary

Enrollment Goal
886
Trial Dates
September 2016 - December 2017
Phase
Phase 4
Could I Receive a placebo
No
Products
Skyla (Levonorgestrel, BAY86-5028)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
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 reasons
    date_rangeTime Frame:
    day 1
    enhanced_encryption
    Safety Issue:
    No
  • 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
    date_rangeTime Frame:
    day 1
    enhanced_encryption
    Safety Issue:
    No
  • Knowledge of Jaydess or other IUDs prior to the visit
    The participants select the reason out of a given list of 3 possible reasons
    date_rangeTime Frame:
    day 1
    enhanced_encryption
    Safety Issue:
    No
  • Is the first intrauterine device prescribed?
    Possible reasons: Yes or No
    date_rangeTime Frame:
    day 1
    enhanced_encryption
    Safety Issue:
    No
  • Person who encouraged the use of jaydess?
    The participants select the answer out of a given list of 5 possible people
    date_rangeTime Frame:
    day 1
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • 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
    date_rangeTime Frame:
    day 1
    enhanced_encryption
    Safety Issue:
    No
  • Uterine length as measured by ultrasonography
    date_rangeTime Frame:
    day 1
    enhanced_encryption
    Safety Issue:
    No
  • Presence of dysmenorrhea (Y/N)
    date_rangeTime Frame:
    day 1
    enhanced_encryption
    Safety Issue:
    No
  • Current contraception method
    The participants select out of a given list of 20 options
    date_rangeTime Frame:
    day 1
    enhanced_encryption
    Safety Issue:
    No
  • Date of birth
    date_rangeTime Frame:
    day 1
    enhanced_encryption
    Safety Issue:
    No
  • Marital status
    date_rangeTime Frame:
    day 1
    enhanced_encryption
    Safety Issue:
    No
  • Place of birth
    date_rangeTime Frame:
    day 1
    enhanced_encryption
    Safety Issue:
    No
  • Place of residence
    date_rangeTime Frame:
    day 1
    enhanced_encryption
    Safety Issue:
    No
  • Educational level
    date_rangeTime Frame:
    day 1
    enhanced_encryption
    Safety Issue:
    No
  • Employment
    date_rangeTime Frame:
    day 1
    enhanced_encryption
    Safety Issue:
    No
  • Income level
    date_rangeTime Frame:
    day 1
    enhanced_encryption
    Safety Issue:
    No
  • Do you have children? (Y/N)
    date_rangeTime Frame:
    day 1
    enhanced_encryption
    Safety Issue:
    No
  • Number of children
    date_rangeTime Frame:
    day 1
    enhanced_encryption
    Safety Issue:
    No
  • Has she had some birth vaginally? (Y/N)
    date_rangeTime Frame:
    day 1
    enhanced_encryption
    Safety Issue:
    No
  • Date of last birth
    date_rangeTime Frame:
    day 1
    enhanced_encryption
    Safety Issue:
    No
  • Do you plan to have (more) children? (Yes/No/Unknown)
    date_rangeTime Frame:
    day 1
    enhanced_encryption
    Safety Issue:
    No
  • When she plans to have (more) children
    date_rangeTime Frame:
    day 1
    enhanced_encryption
    Safety Issue:
    No
  • Frequency of menstrual bleeding
    date_rangeTime Frame:
    day 1
    enhanced_encryption
    Safety Issue:
    No
  • Regularity of menstrual bleeding
    date_rangeTime Frame:
    day 1
    enhanced_encryption
    Safety Issue:
    No
  • Quantity of menstrual bleeding
    date_rangeTime Frame:
    day 1
    enhanced_encryption
    Safety Issue:
    No
  • Duration of menstrual bleeding
    date_rangeTime Frame:
    day 1
    enhanced_encryption
    Safety Issue:
    No
  • Absence of menstrual bleeding
    date_rangeTime Frame:
    day 1
    enhanced_encryption
    Safety Issue:
    No
  • Questionnaire concerning the physicians' characteristics
    The questionnaire consists of 7 questions
    date_rangeTime Frame:
    day 1
    enhanced_encryption
    Safety Issue:
    No

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
N/A

Additional Information

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