New phase 3 data support the use of the levonorgestrel 52 mg intrauterine device (IUD) in nulliparous women with obesity and heavy menstrual bleeding. The findings, presented at the 2022 annual meeting of the American College of Obstetricians and Gynecologists (ACOG), showed a 97% reduction in blood loss 6 months after placement of the device, which is sold as the contraceptive Liletta by Medicines360 and AbbVie.
Experts say the results fill a gap in research because prior clinical trials of the IUD and a competitor, Mirena (Bayer), excluded significantly obese as well as nulliparous populations.
William Schlaff, MD, professor and chairman of the Department of Obstetrics & Gynecology, Thomas Jefferson University, Philadelphia, said the absence of confirmatory evidence in these women has meant that although use of the IUD has been “pretty widespread,” clinicians have been uncertain about the efficacy of the approach.
“Now we have objective data from a well-designed study that supports a practice that many of us have felt is probably a good one,” Schlaff, who was not involved in the new study, told Medscape Medical News.
Lead researcher Mitchell Creinin, MD, professor of obstetrics and gynecology at UC Davis Health, Sacramento, and colleagues at several centers across the country provided treatment with Liletta to 105 individuals with proven heavy menstrual bleeding. The patients’ median blood loss during two menses prior to placement of the device was 165 mL (range, 73-520 mL).
Participant demographics were: 65% White, 24% Black, 10% Hispanic, 4% Asian, and 7% who identified with other racial groups. Mean body mass index (BMI) was 30.9, and 45% of individuals met the criteria for obesity (BMI > 30), including 13% who had a BMI ≥ 40. Nearly 30% of participants in the study had never given birth and none had known medical, anatomic, infectious, or neoplastic causes of bleeding.
According to Creinin, 86 women were assessed 3 months after device placement, and their median blood loss at the time was 9.5 mL (interquartile range [IQR], 2.5-22.9 mL), representing a median 93% decrease from baseline. Median blood loss 6 months after placement of the IUD was 3.8 mL (IQR, 0-10.1 mL), a 97% reduction from baseline.
Regardless of parity or BMI, blood loss at 6 months was 97%-97.5% lower than baseline, Creinin reported.
Among the 23% of participants who did not complete the study, 4% experienced expulsions of the device, which Creinin said is a rate twice as high as that seen in women using hormone-releasing IUDs for contraception. However, he said it “is consistent with other studies among patients with quantitatively proven heavy menstrual bleeding.”
Another 6% of women who did not complete the study removed the device owing to bleeding and cramping complaints. Nine percent were lost to follow-up or withdrew consent and 5% discontinued treatment for unspecified reasons, Creinin said.
“Etiologies for heavy menstrual bleeding may be different in the individuals we studied, so our findings provide assurance that these populations with heavy menstrual bleeding are equally well treated” with the IUD, Creinin said.
Creinin reported study funding from Medicines360. Schlaff reported no financial conflicts of interest.
American College of Obstetricians and Gynecologists 2022 annual meeting. Abstract A116. Presented May 6.
David Wild is a medical writer in Toronto.