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Five-year clinical experiences with NOVA T 380 copper IUD.
I Batár1, A Kuukankorpi, M Siljander
1Department of Obstetrics and Gynecology, University of Debrecen, Debrecen, Hungary. ibatar@jaguar.dote.hu
Contraception
|November 22, 2002
Summary
The NOVA T 380 intrauterine device demonstrated good 5-year clinical performance and acceptable safety in a phase III trial. This high-loaded copper device showed low discontinuation rates for pregnancy and expulsion.
Area of Science:
- Reproductive Health
- Medical Devices
- Clinical Trials
Background:
- The NOVA T 380 is a modified intrauterine device (IUD) featuring an increased copper surface area (380 mm²).
- Long-term clinical performance data for high-copper-loaded IUDs are crucial for contraceptive counseling and device selection.
Purpose of the Study:
- To evaluate the 5-year clinical performance and safety of the NOVA T 380 IUD.
- To assess discontinuation rates due to various reasons, including pregnancy, expulsion, bleeding, pain, and personal choice.
Main Methods:
- An open-label, single-group, phase III clinical trial was conducted across three centers.
- 400 women were enrolled, with follow-up extending to 60 months for participants who completed the study.
- Kaplan-Meier estimates were used to calculate cumulative discontinuation and continuation rates.
Main Results:
- The 5-year cumulative discontinuation rates per 100 users were: pregnancy (1.9), expulsion (4.1), bleeding (14.0), pain (4.2), medical removal (6.4), planning pregnancy (13.5), and personal removal (11.9).
- No ectopic pregnancies or pelvic inflammatory diseases (PIDs) were reported.
- One device perforation (0.3 per 100 women) occurred within the first year. Continuation rates were 88.3% at 1 year and 52.5% at 5 years.
Conclusions:
- The NOVA T 380 IUD exhibits favorable 5-year clinical performance, comparable to other high-loaded copper IUDs.
- The device demonstrated acceptable safety over the 5-year study period, with no PIDs or ectopic pregnancies observed.