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Completed

NCT Number: NCT02903888

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

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.

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Key information

Conditions

Intrauterine Devices, Medicated

Age range

18 year–29 year

Sex eligibility

Female

Study type

Observational

Primary location

Multiple Locations, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Levonorgestrel (Jaydess, Skyla, BAY86-5028)

Drug

Intrauterine delivery system Jaydess (13.5 mg levonorgestrel)

Primary outcomes

  1. Reason for choosing Jaydess as intrauterine device (IUD)

    Time frame: day 1

    The participants select the reason out of a given list of 15 possible reasons

  2. Reason for switching to Jaydess if used another type of intrauterine device before

    Time frame: day 1

    The participants select the reason out of a given list of 10 possible reasons

  3. Knowledge of Jaydess or other IUDs prior to the visit

    Time frame: day 1

    The participants select the reason out of a given list of 3 possible reasons

  4. Is the first intrauterine device prescribed?

    Time frame: day 1

    Possible reasons: Yes or No

  5. Person who encouraged the use of jaydess?

    Time frame: day 1

    The participants select the answer out of a given list of 5 possible people

Secondary outcomes

  1. Reason for not using Jaydess or other intrauterine delivery system (IUD) before

    Time frame: day 1

    The participants select the reason out of a given list of 12 possible reasons

  2. Uterine length as measured by ultrasonography

    Time frame: day 1

  3. Presence of dysmenorrhea (Y/N)

    Time frame: day 1

  4. Current contraception method

    Time frame: day 1

    The participants select out of a given list of 20 options

  5. Date of birth

    Time frame: day 1

  6. Marital status

    Time frame: day 1

  7. Place of birth

    Time frame: day 1

  8. Place of residence

    Time frame: day 1

  9. Educational level

    Time frame: day 1

  10. Employment

    Time frame: day 1

  11. Income level

    Time frame: day 1

  12. Do you have children? (Y/N)

    Time frame: day 1

  13. Number of children

    Time frame: day 1

  14. Has she had some birth vaginally? (Y/N)

    Time frame: day 1

  15. Date of last birth

    Time frame: day 1

  16. Do you plan to have (more) children? (Yes/No/Unknown)

    Time frame: day 1

  17. When she plans to have (more) children

    Time frame: day 1

  18. Frequency of menstrual bleeding

    Time frame: day 1

  19. Regularity of menstrual bleeding

    Time frame: day 1

  20. Quantity of menstrual bleeding

    Time frame: day 1

  21. Duration of menstrual bleeding

    Time frame: day 1

  22. Absence of menstrual bleeding

    Time frame: day 1

  23. Questionnaire concerning the physicians' characteristics

    Time frame: day 1

    The questionnaire consists of 7 questions

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Acronym: ANALIA

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 16, 2016
Registry last updated
Jan 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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