General Medicine

Liletta Approval Expanded to Include Treatment of Heavy Menstrual Bleeding

Diana Ernst, RPh
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Publish Date
For individuals who practice intrauterine contraception, Liletta can help treat heavy menstrual bleeding.

The Food and Drug Administration (FDA) has expanded the approval of Liletta® (levonorgestrel-releasing intrauterine system) for the treatment of heavy menstrual bleeding for up to 5 years in patients who choose intrauterine contraception as their method of contraception.

The approval was based on data from an open-label phase 3 study (ClinicalTrials.gov Identifier: NCT03642210) that included 105 participants 18 to 50 years of age with no contraindications to Liletta and with confirmed heavy menstrual bleeding (≥80 mL menstrual blood loss [MBL] per menses). Participants were excluded from the study if they had any structural or diagnosed pathophysiologic conditions that caused the heavy uterine bleeding.

The primary endpoint of the study was the proportion of women with successful treatment, defined as an end-of-treatment MBL of less than 80 mL and at least a 50% reduction in MBL from baseline.

Study participants had a median baseline MBL of 143.2 mL. Median body mass index was reported to be 29.7 kg/m2; 23.8% of participants were overweight and 48.6% were obese. At the end of the study, results showed that 80% (95% CI, 71-88) of participants had successful treatment. At 3 months and 6 months, the median MBL percent reduction from baseline was 91% and 96%, respectively. Outcomes were found to be similar for obese and nonobese participants and for nulliparous and parous women.

The safety of Liletta was consistent with the adverse reaction profile observed in the contraception study. The progestin-containing IUD is also indicated for the prevention of pregnancy for up to 8 years. Expulsions (4.8%) and bleeding pattern alterations (3.8%) were reported as the most common adverse reactions leading to discontinuation in the heavy menstrual bleeding trial.

The Liletta IUD consists of a T-shaped polyethylene frame with a drug reservoir containing 52mg levonorgestrel, packaged within a sterile inserter. For the treatment of heavy menstrual bleeding, Liletta should be replaced by the end of the fifth year if continued use is needed.

This article originally appeared on MPR

References:
  1. US Food and Drug Administration. Liletta. Supplement Approval. Accessed July 5, 2023. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/206229Orig1s013ltr.pdf.
  2. Package insert. AbbVie and Medicines360; 2023. Accessed July 5, 2023. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/206229s013lbledt.pdf.
  3. Crenin MD, Barnhart KT, Gawron LM, et al. Heavy menstrual bleeding treatment with a levonorgestrel 52-mg intrauterine device. Obstetrics & Gynecology. Published online April 5, 2023. doi:10.1097/AOG.0000000000005137