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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT02903888
Date of registration:	13/09/2016
Prospective Registration:	No
Primary sponsor:	Bayer
Public 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 ANALIA
Scientific 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
Date of first enrolment:	September 8, 2016
Target sample size:	886
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02903888
Study type:	Observational
Study design:
Phase:

Countries of recruitment
Spain

Contacts

Name:	Bayer Study Director
Address:
Telephone:
Email:
Affiliation:	Bayer

Key inclusion & exclusion 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.

Age minimum: 18 Years
Age maximum: 29 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Intrauterine Devices, Medicated

Intervention(s)

Drug: Levonorgestrel (Jaydess, Skyla, BAY86-5028)

Primary Outcome(s)

Reason for switching to Jaydess if used another type of intrauterine device before [Time Frame: day 1]

Knowledge of Jaydess or other IUDs prior to the visit [Time Frame: day 1]

Person who encouraged the use of jaydess? [Time Frame: day 1]

Is the first intrauterine device prescribed? [Time Frame: day 1]

Reason for choosing Jaydess as intrauterine device (IUD) [Time Frame: day 1]

Secondary Outcome(s)

Quantity of menstrual bleeding [Time Frame: day 1]

Questionnaire concerning the physicians' characteristics [Time Frame: day 1]

When she plans to have (more) children [Time Frame: day 1]

Do you have children? (Y/N) [Time Frame: day 1]

Income level [Time Frame: day 1]

Place of residence [Time Frame: day 1]

Regularity of menstrual bleeding [Time Frame: day 1]

Absence of menstrual bleeding [Time Frame: day 1]

Frequency of menstrual bleeding [Time Frame: day 1]

Date of birth [Time Frame: day 1]

Employment [Time Frame: day 1]

Number of children [Time Frame: day 1]

Presence of dysmenorrhea (Y/N) [Time Frame: day 1]

Date of last birth [Time Frame: day 1]

Do you plan to have (more) children? (Yes/No/Unknown) [Time Frame: day 1]

Duration of menstrual bleeding [Time Frame: day 1]

Uterine length as measured by ultrasonography [Time Frame: day 1]

Marital status [Time Frame: day 1]

Current contraception method [Time Frame: day 1]

Educational level [Time Frame: day 1]

Has she had some birth vaginally? (Y/N) [Time Frame: day 1]

Place of birth [Time Frame: day 1]

Reason for not using Jaydess or other intrauterine delivery system (IUD) before [Time Frame: day 1]

Secondary ID(s)

18883

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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