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 (≥80mL 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 80mL and at least a 50% reduction in MBL from baseline.

Study participants had a median baseline MBL of 143.2mL. Median body mass index was reported to be 29.7kg/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.

(HealthDay News) — For patients with adenomyosis, mifepristone is efficacious and has acceptable tolerability, according to a study published online June 12 in JAMA Network Open.

Xuan Che, PhD, from Zhejiang University in Hangzhou, China, and colleagues examined whether mifepristone is effective and safe for adenomyosis treatment in a multicenter trial conducted in 10 hospitals in China. A total of 134 patients with adenomyosis pain symptoms were enrolled and randomly assigned to receive mifepristone 10mg or placebo once a day for 12 weeks. Overall, 126 patients were included in the efficacy analysis: 61 and 65 in the mifepristone and placebo groups, respectively.

The researchers found that the mean change in visual analog scale score after 12 weeks of treatment was −6.63 in the mifepristone group and −0.95 in the placebo group. The total remission rates for dysmenorrhea were significantly better in the mifepristone vs placebo group (effective remission: 91.8% vs 23.1%; complete remission: 88.5% vs 6.2%).

Significant improvements were seen in all secondary end points in the mifepristone group, including menstrual blood loss, hemoglobin, CA125, platelet count, and uterine volume. No significant difference was seen between the groups in the safety analysis, and there were no reports of serious adverse events.

“Adenomyosis-associated dysmenorrhea intensity was significantly reduced after mifepristone treatment. Regardless of how severe the intensity of dysmenorrhea, the total efficacy for dysmenorrhea was satisfactory,” the authors write. “Further research is still needed to determine the long-term safety and efficacy.”

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