A randomized trial comparing the 52-mg levonorgestrel system with combination oral contraceptives for treatment of heavy menstrual bleeding

BACKGROUND: The levonorgestrel intrauterine system and combined oral contraceptives are the 2 most commonly used nonsurgical 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: This study aimed to compare the effectiveness of the 52-mg levonorgestrel intrauterine system with that of combined oral con-traceptives for improving quality of life among individuals who self-report heavy menstrual bleeding. We hypothesized that the levonorgestrel in-trauterine system would be more effective than combined oral contra-ceptives at 6 and 12 months after treatment. STUDY DESIGN: We conducted a pragmatic randomized trial of in-dividuals 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 nonstructural cause of heavy menstrual bleeding. Eligible and consenting participants were randomly assigned in a 1:1 ratio to receive a 52-mg levonorgestrel intrauterine system or a monophasic 30-or 35-mg 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 multi-variable linear mixed-effects regression; 24 participants per group were needed to detect a 10-point difference in change in mean Menstrual Bleeding Questionnaire score between individuals treated with the levo-norgestrel intrauterine system and those treated with combined oral contraceptives at each follow-up time point.RESULTS: A total of 62 individuals were randomly assigned to treat-ment (n=29 allocated to levonorgestrel intrauterine system and n=33 allocated to combined oral contraceptives) and included in the intention-to-treat analyses; 19 of 29 received the levonorgestrel intrauterine system and 31 of 33 received combined oral contraceptives. Eleven percent identified as Black or African American and 44% identified as Hispanic or Latina. Participant characteristics were similar among study groups. Bleeding-related quality of life increased in both study arms, as reflected by a significant decrease in Menstrual Bleeding Questionnaire scores beginning at 6-week follow-up. In the main intention-to-treat analyses (n=62), there were no differences in mean change in Men-strual Bleeding Questionnaire scores at 6 months (difference=-2.5; 95% confidence interval,-10.0 to +5.0) or 12 months (differ-ence=-1.1; 95% confidence interval,-8.7 to +6.5). 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 Ques-tionnaire score was observed in the levonorgestrel intrauterine system arm at 6 months after treatment (difference=-7.0; 95% confidence interval,-13.8 to-0.2) but not at 12 months (difference=-4.8; 95% confidence interval,-11.8 to 2.3) compared with the combined oral contraceptive arm.CONCLUSION: No differences in change of bleeding-related quality of life were observed between the levonorgestrel intrauterine system 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.

Automated summary

This study compared the effectiveness of the levonorgestrel intrauterine system and combined oral contraceptives in improving quality of life for individuals with heavy menstrual bleeding, and found no significant differences between the two treatments.