Hormone-free, low-dose copper IUD effective for pregnancy prevention, with high placement success

Key takeaways:

• Newly-designed hormone-free IUD was successful for preventing pregnancy at 3 years.
• Placement success was high for both nulliparous and parous participants, and clinicians and users reported positive experiences.

BALTIMORE — New phase 3 data demonstrate efficacy of an investigational next-generation, hormone-free, low-dose copper IUD for prevention of pregnancy through 3 years of use.

In addition, clinicians and study participants reported positive experiences with placement of the IUD, with high placement success rates, according to data presented at the ACOG Annual Clinical & Scientific Meeting.

The Copper 175 mm² IUD (Sebela Women’s Health) was studied in a phase 3, prospective, single-arm, open-label study. Researchers enrolled women aged 17 to 45 years at 42 U.S. centers. The intention-to-treat population included 1,620 women (60.1% nulliparous; 39.9% parous). The primary outcome was contraceptive efficacy through 3 years of use, which was assessed by the Pearl Index (defined as number of pregnancies per 100 women).

“The only copper IUD currently available in the U.S. was FDA approved in 1984, the year the Macintosh computer was introduced. Clearly, there is a lot of progress to be made for people seeking long-acting, highly-effective, hormone-free contraception, and that is what this study reports on,” David K. Turok, MD, MPH, associate professor in the department of obstetrics and gynecology at University of Utah, told Healio.

In terms of efficacy, the 1-year Pearl Index was 0.94 (95% CI, 0.43-1.78) and 1-year life-table pregnancy rate was 1.26% (95% CI, 0.57-1.95). At 3 years, the cumulative Pearl Index was 0.96 (95% CI, 0.59-1.48) and the 3-year life-table pregnancy rate was 2.47% (95% CI, 1.34-3.6), according to the results.

Researchers also compared the experiences of nulliparous and parous users for IUD placement attempt, including successful placement, participant-reported pain, investigator-reported ease of IUD placement, need for mechanical cervical dilation and uterine perforation.

IUD placement is generally perceived to be more challenging for nulliparous users, compared with parous users, Turok said during the presentation.

Successful placement, including second attempts, occurred in 98.8% of participants. Placement success was high for both nulliparous and parous participants, according to Turok. Placement success on the first attempt was 95.7% for nulliparous participants and 95.7% for parous participants. When second attempts were included, the success rate was 98.7% and 99.1%, respectively, according to the results.

Nulliparous participants reported more pain compared with parous participants. Mean pain score was 5.6 vs. 4, respectively, after the first attempt (P < .001) and 6.3 vs. 4.7, respectively, for the second attempt. Procedural pain was also higher for nulliparous women, and 21.2% reported pain-related adverse events associated with IUD placement compared with 10.1% of parous women (P < .001). Perforations were rare in both groups, according to the results.

The most common adverse events included heavy menstrual bleeding, dysmenorrhea, pelvic discomfort and intermenstrual bleeding. Over 3 years, 15.4% of participants discontinued due to bleeding or pain; 8.6% of participants discontinued in the first year, according to the results.

“The study results are very promising and show a low expulsion rate and relatively few participants discontinuing for pain and bleeding. This IUD has tremendous promise and could be a very favorable step forward for U.S. contraceptive options,” Turok told Healio.

The Copper 175 mm² IUD has a flexible frame made of nitinol. The frame measures 32 mm horizontally and 30 mm vertically with pre-cut retrieval strings. The sterile IUD does not require loading, according to a company press release.

“This novel IUD has several features which make it easy to place and easy to use. Most importantly, it has less than half the copper compared to the currently used copper IUD in the U.S.,” Turok told Healio.

The study is ongoing and will continue to assess use beyond 3 years, according to the release.

References:

• Roe AH, et al. Obstet Gynecol. 2023;doi:10.1097/01.AOG.0000931256.30898.ff.
• Sebela Women's Health Announces Positive Phase 3 Data for its Investigational, Next-Generation, Hormone-Free, Low-Dose Copper Intrauterine Device (IUD). https://sebelapharma.com/assets/media/FINAL51523ACOGDataPressRelease.pdf. Published May 18, 2023. Accessed May 21, 2023.