Trial Condition(s):

Menorrhagia, Dysmenorrhea

Prospective, non-interventional, multi-center safety study of Mirena for Heavy Menstrual Bleeding and Dysmenorrhea (J-MIRAI)

Bayer Identifier:

18252

ClinicalTrials.gov Identifier:

NCT02475356

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

Inclusion Criteria
- Female patients diagnosed with HMB or/and dysmenorrhea.
 - Patients for whom newly starting treatment with Mirena was made as per investigator’s routine treatment practice 
- Written informed consent
Exclusion Criteria
- Patient whose purpose is only contraception

Trial Summary

Enrollment Goal
601
Trial Dates
black-arrow
Phase
4
Could I receive a placebo?
No
Products
Mirena (Levonorgestrel IUS, BAY86-5028)
Accepts Healthy Volunteers
No

Where to Participate

Loading...
Locations
Status
LocationsStatus
Locations

Investigative Site

Many Locations, Japan

Status
Completed
 

Trial Design