Three-year efficacy, safety, and tolerability outcomes from a phase 3 study of a low-dose copper intrauterine device

Mitchell D. Creinin, Lori M. Gawron, Andrea H. Roe, Paul D. Blumenthal, Christy M. Boraas, Melody Y. Hou, Colleen McNicholas, Mary Jo Schreifels, Kevin Peters, Kelly Culwell, David K. Turok

Research output: Contribution to journalArticlepeer-review

Abstract

Objectives: This study aimed to assess 3-year efficacy, safety, and tolerability of the Cu 175 mm2 intrauterine device (IUD). Study design: This single-arm trial recruited participants at risk of pregnancy aged 17 to 45 years at 42 U.S. centers to receive a Cu 175 mm2 IUD with a flexible nitinol frame. We assessed efficacy in participants aged ≤35 years at enrollment and assessed all other outcomes in the entire population. We calculated the Pearl Index (pregnancies/100 person-years) through 3 years as the primary efficacy outcome. The secondary outcomes included pregnancy percentages by life-table analysis, placement success, safety (adverse events), and tolerability. Results: Of 1620 enrollees, 1601 (98.8%) had successful IUD placement, with 1397 aged ≤35 years at enrollment. We observed a 1-year Pearl Index of 0.94 (95% CI 0.43–1.78) and 1-year and cumulative 3-year life-table pregnancy rates of 1.26% (95% CI 0.57%–1.95%) and 2.47% (95% CI 1.34%–3.60%), respectively. The most common adverse events included bleeding and pain. Over 3 years, 15.4% of participants discontinued due to bleeding or pain. Device expulsions occurred in 36 (2.2%) and 63 (3.9%) participants over 1 and 3 years, respectively. Eight related serious adverse events occurred, including five ectopic pregnancies and one each of uterine perforation, anemia, and uterine hemorrhage. One- and three-year continuation rates were 78.9% and 49.6%, respectively. Conclusions: These data support efficacy, safety, and tolerability of the Cu 175 mm2 IUD during the first 3 years of use. Implications: In this Phase 3 trial, the investigational Cu 175 mm2 demonstrated efficacy, safety, and tolerability with low rates of expulsion and discontinuation for bleeding and pain-related symptoms. This flexible, nitinol-framed, low-dose copper IUD comes preloaded and would expand contraceptive options beyond the single nonhormonal IUD currently available in the United States.

Original languageEnglish (US)
Article number110771
JournalContraception
Volume143
DOIs
StateAccepted/In press - 2024

Bibliographical note

Publisher Copyright:
© 2024 Elsevier Inc.

Keywords

  • Contraception
  • Copper intrauterine device
  • Efficacy
  • Long-acting reversible contraception
  • Safety

PubMed: MeSH publication types

  • Journal Article
  • Clinical Trial, Phase III
  • Multicenter Study

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