Five-Year Phase 3 Efficacy and Safety Outcomes With a Low-Dose Copper Intrauterine Device

Area of Science:

• Reproductive health
• Contraception
• Medical device technology

Background:

• A novel nitinol-framed, low-dose copper intrauterine device (IUD) was developed.
• ClinicalTrials.gov identifier: NCT03633799.

Purpose of the Study:

• To evaluate the 5-year contraceptive efficacy and safety of the Cu 175 mm2 IUD.
• Assess adverse events and discontinuation rates.

Main Methods:

• Single-arm phase 3 trial including 1,620 participants aged 17-45.
• Contraceptive efficacy assessed by Pearl Index and life table analysis.
• Follow-up extends to 8 years, with 5-year data analyzed.

Main Results:

• Cumulative 5-year Pearl Index was 1.02 (95% CI, 0.68-1.47).
• Cumulative 5-year life table pregnancy rate was 4.1% (95% CI, 2.8-6.0%).
• Discontinuation for bleeding/pain decreased from 8.7% in year 1 to 1.9% in year 5; 4.7% cumulative expulsion rate.

Conclusions:

• The Cu 175 mm2 IUD demonstrates favorable efficacy and safety over 5 years.
• Low and decreasing rates of discontinuation for bleeding and pain support long-term use.