Trial Condition(s):

Contraception

Mirena post-marketing surveillance in Japan

Bayer Identifier:

15036

ClinicalTrials.gov Identifier:

NCT01414140

EudraCT Number:

Not Available

Study Completed

Trial Purpose

This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of women who are inserted Mirena for intrauterine contraception. The objective of this study is to assess safety and effectiveness of Mirena under real-life practice conditions. A total 550 patients will be recruited and followed for 5 years.

Inclusion Criteria
- Women who are inserted Mirena for intrauterine contraception
Exclusion Criteria
- Women who are contraindicated based on the product label

Trial Summary

Enrollment Goal
567
Trial Dates
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Phase
N/A
Could I receive a placebo?
No
Products
Mirena (Levonorgestrel IUS, BAY86-5028)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Many locations, Japan

Status
Completed
 

Trial Design