Levonorgestrel IUD reduces blood loss by more than 90% in those with heavy menstrual bleeding
Click Here to Manage Email Alerts
Key takeaways:
- The Liletta levonorgestrel-releasing intrauterine device decreased bleeding in those with heavy menstrual bleeding.
- Reduced bleeding also had a substantial impact on quality of life.
BALTIMORE — Patients with heavy menstrual bleeding who received the levonorgestrel 52 mg intrauterine device experienced significant and rapid decreases in uterine bleeding after placement, a researcher reported here.
Blood loss was reduced by more than 90% over 6 months after placement of the Liletta levonorgestrel-releasing intrauterine system (AbbVie/Medicines360) compared with baseline for most with heavy menstrual bleeding, according to Mitchell D. Creinin, MD, professor in the department of obstetrics and gynecology at University of California Davis Health System in Sacramento.
“The benefit was similar in nulliparous and parous patients and in patients with and without obesity,” Creinin said during the late-breaking studies presentation at the ACOG Annual Clinical & Scientific Meeting.
Results of this phase 3 study were also recently published in Obstetrics & Gynecology.
The study was planned to add treatment of heavy menstrual bleeding to the FDA-approved indications for Liletta, Creinin previously told Healio.
The study was conducted at 29 U.S. sites and enrolled participants who were aged 16 to 50 years, had regular menstrual cycles and no pelvic or systemic pathology causing heavy menstrual bleeding.
The researchers enrolled 105 patients (mean age, 35.4 years; 65% white; 48% BMI 30 kg/m2; 28% nulliparous) who had two menses with at least 80 mL of blood within three screening cycles. They measured median absolute change in blood loss using the average amount of blood lost during screening menses and during menses at 3 and 6 months after placement of the levonorgestrel 52 mg IUD.
Treatment success, defined as blood loss during IUD treatment < 80 mL and > 50% reduction from baseline to final cycle, was 77.1% in the total enrolled population and 81.8% in the total population excluding those lost to follow-up and consent withdrawal, according to Creinin.
“Treatment success did not vary by BMI or parity — not even a hint of any difference,” Creinin said.
Median blood loss at baseline was 143 mL. After placement, mean blood loss was reduced by 93.3% by cycle 3 and 97.6% by cycle 6, demonstrating a “dramatic impact on blood loss,” Creinin said. There was no difference in the decrease in blood loss over six cycles in those who were nulliparous or had a higher BMI, according to Creinin.
Results also showed a benefit in quality of life, including dramatic decreases in patient responses to how heavy their bleeding is, cramping pain and improved sleep patterns, according to Creinin.
The rate of expulsion in this study was 9%, which Creinin said is higher than seen with the contracepting population, and likely impacted in this study by obesity and parity.