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Prospective, Non-interventional, Multi-center Safety Study of Mirena for Heavy Menstrual Bleeding and Dysmenorrhea

NCT02475356 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 601

Last updated 2021-01-28

No results posted yet for this study

Summary

The primary objective in this study is collecting post-marketing information on the safety. Thus, it includes information under the routine clinical practice on adverse events (AEs) and adverse drug reactions (ADRs) including expulsion and abnormal bleeding that occur within the first 12 months Mirena insertion.

The secondary objective(s) in this study is/are collecting information on Mirena effectiveness, such as periodic blood loss and Quality of life (QOL), use of analgesic and dysmenorrhea pain as far as these are recorded under routine clinical practice.

Conditions

  • Menorrhagia, Dysmenorrhea

Interventions

DRUG

Levonorgestrel IUS (Mirena, BAY86-5028)

The treatment of Mirena should comply with the local product information.

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-04
Primary Completion
2019-01-18
Completion
2019-12-12

Countries

  • Japan

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02475356 on ClinicalTrials.gov