Contraceptive Efficacy and Comparative Side Effects of a Mini Copper Intrauterine Device

Area of Science:

• Reproductive Health
• Contraception
• Medical Devices

Background:

• Intrauterine devices (IUDs) are highly effective contraceptives, but user and device characteristics influence acceptability and continuation rates.
• The NTCu380 Mini is a 380 mm² copper IUD available in Europe and Canada.
• The TCu380A is a 380 mm² copper IUD widely used in the United States.

Purpose of the Study:

• To evaluate the efficacy of the NTCu380 Mini copper IUD.
• To compare the safety and continuation rates of the NTCu380 Mini with the TCu380A IUD.
• To assess adverse events associated with both IUDs.

Main Methods:

• A randomized trial assigned participants aged 16–40 years to either the NTCu380 Mini or TCu380A in a 4:1 ratio.
• The study assessed outcomes over 37 months.
• The primary efficacy outcome was the Pearl Index for the NTCu380 Mini in participants aged 35 and under.

Main Results:

• The 3-year cumulative Pearl Index for the NTCu380 Mini was 1.86 pregnancies per 100 woman-years (cumulative pregnancy rate of 4.8%).
• Serious adverse events occurred in 3.5% of NTCu380 Mini users and 1.9% of TCu380A users (P=0.28).
• AEs led to discontinuation less frequently with the NTCu380 Mini (20.8%) compared to the TCu380A (33.2%) (P=0.001), particularly bleeding and pelvic pain.

Conclusions:

• The NTCu380 Mini IUD achieved an approximate 5% pregnancy rate over 3 years in a predominantly nulliparous population.
• Fewer side effects led to discontinuation with the NTCu380 Mini compared to the TCu380A.
• The NTCu380 Mini presents a viable contraceptive option with a favorable side effect profile.