check_circleStudy Completed

contraception

Bayer Identifier:

15036

ClinicalTrials.gov Identifier:

NCT01414140

EudraCT Number:

Not Available

EU CT Number:

Not Available
Mirena post-marketing surveillance in Japan

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.

Key Participants Requirements

Sex

Female

Age

NaN - N/A
  • - Women who are inserted Mirena for intrauterine contraception
  • - Women who are contraindicated based on the product label

Trial summary

Enrollment Goal
567
Trial Dates
May 2007 - October 2012
Phase
N/A
Could I Receive a placebo
No
Products
Mirena (Levonorgestrel IUS, BAY86-5028)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many locations, Japan

Primary Outcome

  • Incidence of adverse drug reactions and serious adverse events in women who are inserted Mirena
    date_rangeTime Frame:
    After Mirera insertion, up to 5 years
    enhanced_encryption
    Safety Issue:
    Yes
  • Incidence of adverse drug reactions, especially Pelvic inflammatory disease in women who are inserted Mirena
    date_rangeTime Frame:
    After Mirera insertion, up to 5 years
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • Incidence of adverse drug reactions in subpopulation in a variety of baseline data (such as demographic data, concomitant disease) and duration of Mirena
    date_rangeTime Frame:
    After Mirera insertion, up to 5 years
    enhanced_encryption
    Safety Issue:
    Yes
  • Pregnancy rate
    date_rangeTime Frame:
    After Mirera insertion, up to 5 years
    enhanced_encryption
    Safety Issue:
    No
  • Released amount of Levonorgestrel [estimated from removed Mirena]
    date_rangeTime Frame:
    After Mirera insertion, up to 5 years
    enhanced_encryption
    Safety Issue:
    No

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
N/A

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here to find results for studies related to Bayer Healthcare products.