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

NCT02903888 | Completed

• 1 other identifier: 18883
• Study Type: observational
• Target: 886
• Locations: 1 country
• Sites: 1

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.

Conditions

Intrauterine Devices, Medicated

Outcome Measures

Primary Outcomes (5)

• Reason for choosing Jaydess as intrauterine device (IUD)

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

  day 1

• 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

  day 1

• Knowledge of Jaydess or other IUDs prior to the visit

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

  day 1

• Is the first intrauterine device prescribed?

  Possible reasons: Yes or No

  day 1

• Person who encouraged the use of jaydess?

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

  day 1

Secondary Outcomes (23)

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

  day 1

• Uterine length as measured by ultrasonography

  day 1

• Presence of dysmenorrhea (Y/N)

  day 1

• Current contraception method

  day 1

• Date of birth

  day 1

Study Arms (1)

BAY86-5028

Women aged 18 to 29 years that use Jaydess for contraception

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

Interventions

Levonorgestrel (Jaydess, Skyla, BAY86-5028) DRUG

Intrauterine delivery system Jaydess (13.5 mg levonorgestrel)

BAY86-5028

Eligibility Criteria

• Age: 18 Years - 29 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Multiple Locations, Spain

Location

MeSH Terms

Interventions

Levonorgestrel

Intervention Hierarchy (Ancestors)

Norgestrel; Norpregnenes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2016
• First Posted: September 16, 2016
• Study Start: September 8, 2016
• Primary Completion: October 30, 2017
• Study Completion: December 23, 2017
• Last Updated: January 12, 2018

Record last verified: 2018-01

Locations

ES (1)