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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00461175
Other study ID # ZEG2006_01
Secondary ID
Status Completed
Phase Phase 4
First received April 16, 2007
Last updated June 24, 2015
Start date November 2006
Est. completion date December 2013

Study information

Verified date June 2015
Source Center for Epidemiology and Health Research, Germany
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Observational

Clinical Trial Summary

The primary objective of the study is to assess the risks of intrauterine device (IUD) use in a study population that is representative for the actual users of the individual IUDs. The primary clinical outcome of interest is the uterine perforation rate.


Description:

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Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Germany Center for Epidemiology and Health Research Berlin

Sponsors (2)

Lead Sponsor Collaborator
Center for Epidemiology and Health Research, Germany Bayer

Country where clinical trial is conducted

Germany, 

References & Publications (2)

Heinemann K, Reed S, Moehner S, Minh TD. Comparative contraceptive effectiveness of levonorgestrel-releasing and copper intrauterine devices: the European Active Surveillance Study for Intrauterine Devices. Contraception. 2015 Apr;91(4):280-3. doi: 10.101 — View Citation

Heinemann K, Reed S, Moehner S, Minh TD. Risk of uterine perforation with levonorgestrel-releasing and copper intrauterine devices in the European Active Surveillance Study on Intrauterine Devices. Contraception. 2015 Apr;91(4):274-9. doi: 10.1016/j.contr — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Contraceptive Failure Intrauterine contraceptive methods have low Pearl Indices. Nevertheless, there is a lack of comparative data between LNG IUS users and copper IUD users. Women with unintended pregnancies were explicitly aked whether the pregnancy occured despite IUD use. The 29 pregnancies that occured after unrecognized IUD expulsion were considered to have resulted from a failure of the contraceptive method and were therefore included in the analysis. Within 12 months No
Primary Uterine Perforation Rate Uterine perforation is a potentially serious complication of intrauterine device (IUD) use. The absolute risk of uterine perforation associated with the LNG IUS in routine medical practice has not hitherto been well defined. It is also unknown whether the perforation rate is higher with this IUD than with copper IUDs. 12 months after insertion Yes