Clinical trial 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
Official title: 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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intrauterine Devices, Medicated
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-09-16
Enrollment: 886
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of women aged 18-29 years, who have freely chosen Jaydess for contraception after being adequately counseled and informed of all contraceptive options by their physician at a previous visit to the study visit in a routine clinical practice setting

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Reason for choosing Jaydess as intrauterine device (IUD)
timeFrame: day 1
measure: Reason for switching to Jaydess if used another type of intrauterine device before
timeFrame: day 1
measure: Knowledge of Jaydess or other IUDs prior to the visit
timeFrame: day 1
measure: Is the first intrauterine device prescribed?
timeFrame: day 1
measure: Person who encouraged the use of jaydess?
timeFrame: day 1
Secondary outcomes:
measure: Reason for not using Jaydess or other intrauterine delivery system (IUD) before
timeFrame: day 1
measure: Uterine length as measured by ultrasonography
timeFrame: day 1
measure: Presence of dysmenorrhea (Y/N)
timeFrame: day 1
measure: Current contraception method
timeFrame: day 1
measure: Date of birth
timeFrame: day 1
measure: Marital status
timeFrame: day 1
measure: Place of birth
timeFrame: day 1
measure: Place of residence
timeFrame: day 1
measure: Educational level
timeFrame: day 1
measure: Employment
timeFrame: day 1
measure: Income level
timeFrame: day 1
measure: Do you have children? (Y/N)
timeFrame: day 1
measure: Number of children
timeFrame: day 1
measure: Has she had some birth vaginally? (Y/N)
timeFrame: day 1
measure: Date of last birth
timeFrame: day 1
measure: Do you plan to have (more) children? (Yes/No/Unknown)
timeFrame: day 1
measure: When she plans to have (more) children
timeFrame: day 1
measure: Frequency of menstrual bleeding
timeFrame: day 1
measure: Regularity of menstrual bleeding
timeFrame: day 1
measure: Quantity of menstrual bleeding
timeFrame: day 1
measure: Duration of menstrual bleeding
timeFrame: day 1
measure: Absence of menstrual bleeding
timeFrame: day 1
measure: Questionnaire concerning the physicians' characteristics
timeFrame: day 1
Other outcomes:
Locations:
city: Multiple Locations
country: Spain
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: