Trial Condition(s):
Contraception
Mirena post-marketing surveillance in Japan
Bayer Identifier:
15036
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT 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
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
| Locations | |
|---|---|
Locations Investigative Site Many locations, Japan | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Drug use investigation of Mirena
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Incidence of adverse drug reactions and serious adverse events in women who are inserted MirenaTimeframe: After Mirera insertion, up to 5 years
- Incidence of adverse drug reactions, especially Pelvic inflammatory disease in women who are inserted MirenaTimeframe: After Mirera insertion, up to 5 years
Secondary Outcome
- Incidence of adverse drug reactions in subpopulation in a variety of baseline data (such as demographic data, concomitant disease) and duration of MirenaTimeframe: After Mirera insertion, up to 5 years
- Pregnancy rateTimeframe: After Mirera insertion, up to 5 years
- Released amount of Levonorgestrel [estimated from removed Mirena]Timeframe: After Mirera insertion, up to 5 years
Additional Information
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