Background: The levonorgestrel intrauterine system and combined oral contraceptives are the two most commonly used non-surgical treatments for heavy menstrual bleeding in the United States. However, there are limited data on their relative effectiveness and on their impact on bleeding-specific quality of life.

Objective: To compare the effectiveness of the 52-mg levonorgestrel intrauterine system to combined oral contraceptives for improving quality of life among individuals who self-report heavy menstrual bleeding. We hypothesized that the levonorgestrel intrauterine system would be more effective than combined oral contraceptives at 6 months and 12 months post-treatment.

Study design: We conducted a pragmatic randomized trial of individuals who self-reported heavy menstrual bleeding. Individuals were eligible if they did not have contraindications to either the levonorgestrel intrauterine system or combined oral contraceptives and were determined to have a non-structural cause of heavy menstrual bleeding. Eligible and consenting participants were randomized in a 1:1 ratio to receive a 52 mg levonorgestrel intrauterine system or a monophasic 30 or 35 mcg ethinyl-estradiol containing combined oral contraceptive. The main outcome was mean change in bleeding-related quality of life, measured by the 20-question Menstrual Bleeding Questionnaire (score range 0-75), at 6 and 12 months. Differences in group means and confidence intervals for the Menstrual Bleeding Questionnaire score were computed by multivariable linear mixed effects regression. Twenty-four participants per group were needed to detect a 10-point difference in change in mean Menstrual Bleeding Questionnaire score between individuals treated with the LNG IUS and individuals treated with COCs at each follow-up timepoint.

Results: Sixty-two individuals were randomized to treatment (n=29 allocated to levonorgestrel intrauterine system and n=33 allocated to combined oral contraceptives) and included in the intention-to-treat analyses. Nineteen (of the 29) received the levonorgestrel intrauterine system and 31(of the 33) received combined oral contraceptives. Eleven percent identified as Black or African American and 44% identified as Hispanic or Latina. Participant characteristics were similar between study groups. Bleeding- quality of life increased in both study arms as reflected by a significant decrease in Menstrual Bleeding Questionnaire scores beginning at 6 weeks follow-up. In the main intention to treat analyses (n=62), there were no differences in mean change in Menstrual Bleeding Questionnaire scores at 6 months or 12 months. Findings were similar in the subsets of participants with any follow-up visits (n=52) and who completed all follow-up visits (n=42). In the per-protocol analyses (n=47), a significantly greater decrease in Menstrual Bleeding Questionnaire score was seen in the levonorgestrel intrauterine system arm at 6 months post-treatment but not at 12 months when compared to the combined oral contraceptive arm.

Conclusion: No significant differences in change of bleeding-related quality of life were observed between the levonorgestrel intrauterine systems and combined oral contraceptives at 6 or 12 months. Patients should be counseled that the levonorgestrel intrauterine system and combined oral contraceptives are both effective options for improving bleeding-related quality of life.