The following is a summary of “A randomized trial comparing the 52-mg levonorgestrel system with combination oral contraceptives for treatment of heavy menstrual bleeding,” published in the November 2023 issue of Obstertrics and gynecology by Matteson, et al.

In the United States, heavy menstrual bleeding is commonly treated with the levonorgestrel intrauterine system and combined oral contraceptives. However, limited data exist on their relative effectiveness and their impact on bleeding-specific quality of life. For a pragmatic randomized trial, researchers sought to compare the effectiveness of the 52-mg levonorgestrel intrauterine system with combined oral contraceptives in improving the quality of life for individuals self-reporting heavy menstrual bleeding. The hypothesis posited that the levonorgestrel intrauterine system would demonstrate superior effectiveness compared to combined oral contraceptives at 6 and 12 months post-treatment.

Conducted among individuals self-reporting heavy menstrual bleeding, the randomized trial included participants without contraindications to either the levonorgestrel intrauterine system or combined oral contraceptives. Participants, determined to have a nonstructural cause of heavy menstrual bleeding, were randomly assigned to receive either the 52-mg levonorgestrel intrauterine system or a monophasic combined oral contraceptive containing 30- or 35-μg ethinyl estradiol in a 1:1 ratio. The primary outcome measured the mean change in bleeding-related quality of life, assessed using the 20-question Menstrual Bleeding Questionnaire (score range: 0–75), at 6 and 12 months. The analysis utilized multivariable linear mixed-effects regression, with a minimum of 24 participants per group required to detect a 10-point difference in the mean Menstrual Bleeding Questionnaire score change between the two treatment groups at each follow-up time point.

A total of 62 individuals were randomly assigned to treatment (29 to levonorgestrel intrauterine system and 33 to combined oral contraceptives). In the intention-to-treat analyses, 19 received the levonorgestrel intrauterine system, and 31 received combined oral contraceptives. Among participants, 11% identified as Black or African American, and 44% identified as Hispanic or Latina. Participant characteristics were similar between study groups. Bleeding-related quality of life improved in both arms, indicated by a significant decrease in Menstrual Bleeding Questionnaire scores at the 6-week follow-up. In the main intention-to-treat analyses (n=62), no differences were observed in the mean change in Menstrual Bleeding Questionnaire scores at 6 months (difference=−2.5; 95% confidence interval, −10.0 to +5.0) or 12 months (difference=−1.1; 95% confidence interval, −8.7 to +6.5). These findings were consistent in subsets of participants with any follow-up visits (n=52) and those who completed all follow-up visits (n=42). In per-protocol analyses (n=47), a significantly greater decrease in Menstrual Bleeding Questionnaire score was noted in the levonorgestrel intrauterine system arm at 6 months after treatment (difference=−7.0; 95% CI, −13.8 to −0.2) but not at 12 months (difference=−4.8; 95% CI, −11.8 to 2.3) compared with the combined oral contraceptive arm.

The study found no significant differences in the change of bleeding-related quality of life between the levonorgestrel intrauterine system and combined oral contraceptives at both 6 and 12 months. Thus, patients should be counseled that both the levonorgestrel intrauterine system and combined oral contraceptives are effective options for enhancing bleeding-related quality of life.

Source: ajog.org/article/S0002-9378(23)00521-5/fulltext