Status:
COMPLETED
The Aim of This Study is to Estimate the Discontinuation Rate of Low-dose Levonorgestrel-releasing Intrauterine System Due to Self-reported Unacceptable Menstrual Bleeding Pattern in Spanish Women Who Are Using it for the First Time How Intrauterine System for Long Acting Contraception
Lead Sponsor:
Bayer
Conditions:
Hormonal Intrauterine Contraception
Eligibility:
FEMALE
18-35 years
Brief Summary
Researchers are looking for better ways to help women prevent pregnancy. Every month, a woman's body prepares for pregnancy in a process called the menstrual cycle. When pregnancy does not happen, men...
Eligibility Criteria
Inclusion
- Women aged 18 to 35 years.
- Women who have freely chosen a low-dose LNG-IUS for the first time as contraceptive method and it has been successfully inserted previously to invite the woman to participate in the study.
- Women capable of reading and writing.
- Women who signed the informed consent form.
- Women who are not participating in an investigational program with interventions outside of routine clinical practice.
- Women without a mental illness and able to make decisions and follow instructions.
- Women without contraindications to a low-dose LNG-IUS according to the local marketing authorization.
- Women without concomitant medications that may lead to changes in the bleeding pattern (e.g. antiplatelet and/or anticoagulants).
Exclusion
- None
Key Trial Info
Start Date :
February 21 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 4 2023
Estimated Enrollment :
316 Patients enrolled
Trial Details
Trial ID
NCT04785950
Start Date
February 21 2021
End Date
May 4 2023
Last Update
June 15 2023
Active Locations (1)
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1
Many locations
Multiple Locations, Spain