Abstract
Purpose
The objective of this open randomized study was to compare the clinical performance
of Nova T��380 and Gyne T��380 Slimline copper intrauterine devices (IUDs).
Materials and Methods
Eligible for analyses were 957 Norwegian parous women aged 18���45 years. Clinical
performance was measured upon the removal of IUD due to contraceptive failure, expulsion,
bleeding, pain, pelvic inflammatory disease and other medical reasons during a 5-year
study period.
Results
The discontinuation rate due to contraceptive failure was significantly higher in
the first year for Nova T��380 users than for Gyne T��380 Slimline users, whereas
no differences were observed thereafter (the 5-year cumulative failure rates were
4.4% and 2.2%, respectively, per 100 women). However, the partial expulsion rate was
significantly higher in the first year for Gyne T��380 Slimline users than for Nova
T��380 users (the 5-year cumulative rates were 3.4% and 1.1,% respectively, per 100
women). No other major differences in reasons for discontinuation were found between
the study groups. There was a slight nonsignificant increase in hemoglobin levels
for both study groups over the course of the study.
Conclusion
Clinical performance was considered satisfactorily high for both devices.
Keywords
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Article info
Publication history
Published online: October 30, 2006
Accepted:
September 7,
2006
Received in revised form:
September 5,
2006
Received:
July 3,
2006
Footnotes
���This study has been financially supported by Schering Oy (formerly Leiras Oy).
Identification
Copyright
© 2007 Elsevier Inc. Published by Elsevier Inc. All rights reserved.