O06 - BLEEDING AND PAIN OVER TIME WITH A NOVEL LOW-DOSE COPPER INTRAUTERINE DEVICE WITH A FLEXIBLE NITINOL FRAME

• Published in: Contraception (Stoneham) Vol. 127
• Main Authors: Gawron, LM, Roe, AH, Boraas, CM, Bernard, C, Westhoff, CL, Culwell, K, Turok, DK
• Format: Journal Article
• Language: English
• Published: Elsevier Inc 01-11-2023
• ISSN: 0010-7824; 1879-0518
• DOI: 10.1016/j.contraception.2023.110152

We aimed to assess bleeding and pain with use of a novel, low-dose copper (175 mm2) intrauterine device (IUD) with a flexible nitinol frame.
Investigators enrolled participants ≤45 years-old desiring long-acting intrauterine contraception in this phase 3, multicenter, single-arm, US-based clinical trial (NCT03633799). We assessed treatment-emergent adverse events (TEAEs) related to bleeding or pain, their frequency over time, and the number resulting in study discontinuation at three years.
In total, 1,601 of 1,620 (98.8%) enrolled participants had a successful IUD insertion. Bleeding or pain-related TEAEs decreased over time. Heavy menstrual bleeding was reported at months 0–3, >3-6, >6–12, >12–24, and >24–36 among 69.0%, 25.0%, 23.1%, 8.9%, and 4.7% of participants, respectively. During this same timeframe, dysmenorrhea reports decreased similarly from 63.8% to 5.2%. Discontinuation rates due to bleeding or pain also decreased over time (eg, heavy menstrual bleeding: 3.7%, Year 1; 1.4%, Year 3). Over three years of observation, bleeding or pain-related TEAEs (>1.0%) reported as the primary reason for study discontinuation were heavy menstrual bleeding (6.1%), dysmenorrhea (3.9%), pelvic discomfort (1.7%), and pelvic pain (1.3%). The most common TEAEs (>20%) related to bleeding or pain were heavy menstrual bleeding (77.9%), dysmenorrhea (73.3%), pelvic discomfort (34.6%), intermenstrual bleeding (30.7%), and pelvic pain (20.4%). Consistent with the TEAE data, diary data showed trends of decreasing bleeding and pain over the first year.
While study participants frequently reported bleeding or pain in the first three months, this dramatically decreased to <10% after Year 1. IUD discontinuations due to bleeding or pain were infrequent and decreased over time.