Levonorgestrel IUD reduces blood loss in heavy menstrual bleeding by more than 90%
SAN DIEGO — Liletta, a levonorgestrel-releasing intrauterine system, reduced blood loss in people with heavy menstrual bleeding by more than 90%, regardless of BMI and parity, according to phase 3 data presented here.
As Healio previously reported, Liletta is currently approved by the FDA to prevent pregnancy for up to 6 years.
“This study was a planned phase 3 trial to add treatment of heavy menstrual bleeding to the FDA-approved indications for Liletta,” Mitchell D. Creinin, MD, a professor in the department of OB/GYN at the University of California Davis Health System in Sacramento, California, told Healio. “The entry criteria required exclusion of participants with fibroids, adenomyosis or any other known pathologic cause for heavy menstrual bleeding.”
Creinin and colleagues enrolled 105 patients (mean age, 35.4 years; 65% white; 45% BMI 30; 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.
Blood loss during screening menses ranged from 73 mL to 520 mL with a median of 143 mL.
Among 86 participants with follow-up at 3 months, median blood loss was 9.5 mL, constituting a 93% reduction in blood loss. The 81 people who participated in follow-up at 6 months had a median blood loss of 3.8 mL, which constituted a 97% reduction in blood loss.
There were no significant differences in blood loss reduction between participants with obesity compared with those without obesity (both 97%) or between nulliparous and parous participants (97% and 97.5%, respectively).
Participants discontinued levonorgestrel IUD use due to expulsion (n = 4; 4%) and removal for bleeding/cramping (n = 6; 6%), and 12 people were lost to follow-up, withdrew consent or chose to discontinue (12%).
Creinin emphasized that it is “important to note that the expulsion rate in this population — consistent with other studies of patients with quantitatively proven [heavy menstrual bleeding] — is relatively high compared to a contraceptive population. This rate is about double what is seen in a contraceptive population of hormonal IUD users.”
Moving forward, Creinin suggested research examine the long-term efficacy of Liletta for heavy menstrual bleeding.
“This study was not designed to answer this question, but it would be helpful for patients and clinicians to know if the decrease in heavy bleeding is maintained for the full length of contraceptive efficacy or [if] it returns within a few years,” Creinin said.