Levonorgestrel intrauterine system as effective as combined oral contraceptives for heavy menstrual bleeding
Levonorgestrel intrauterine system is equally effective as combined oral contraceptives in regulating the bleeding-related quality of life among women with heavy menstrual bleeding at 6 or 12 months. Though Levonorgesterol reduced menstrual bleeding significantly in the first 6 months, no difference was noted between Levonorgestrel intrauterine system and combined oral contraceptives at 12 months.
The trial results were published in the American Journal of Obstetrics & Gynecology on August 1st, 2023.
Abnormal uterine bleeding is a common gynecological complaint among middle-aged women constituting one-third of all outpatient gynecological visits. It affects psychological, social, medical, sexual problems, and thus reducing the quality of life. Hence it is necessary for appropriate and adequate management. Levonorgestrel intrauterine system and combined oral contraceptives are the two most commonly used non-surgical treatment options effective for heavy menstrual bleeding.
Due to the uncertainty on their relative effectiveness and their impact on bleeding-specific quality of life, researchers from the University of Massachusetts Memorial Hospital and Warren Alpert Medical School of Brown University conducted a randomized controlled trial on 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.
A pragmatic randomized trial was carried out on individuals who self-reported heavy menstrual bleeding. Eligible participants who had no contraindications to either the levonorgestrel intrauterine system or combined oral contraceptives and were determined to have a non-structural cause of heavy menstrual bleeding were randomized in a 1:1 ratio to receive a 52 mg levonorgestrel intrauterine system or a monophasic 30 or 35 mcg ethinylestradiol containing combined oral contraceptive.
The main outcome was a 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. Multivariable linear mixed effects regression was used to compute the differences in group means and confidence intervals for the Menstrual Bleeding Questionnaire score. 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 time point.
Sixty-two individuals were randomized to two arms where 29 were allocated to the levonorgestrel intrauterine system and 33 to combined oral contraceptives (included in the intention-to-treat analyses). Nineteen (of the 29) participants received the levonorgestrel intrauterine system, and 31(of the 33) participants received combined oral contraceptives. Eleven percent identified as Black or African American, and 44% identified as Hispanic or Latina.
What did the study find?
- 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 six 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 six months or 12 months.
- Similar findings were found 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 significant decrease in the menstrual bleeding questionnaire score was seen in the levonorgestrel intrauterine system arm at six months post-treatment but not at twelve months compared to the combined oral contraceptive arm.
Thus, bleeding-related quality of life change was similar in the levonorgestrel intrauterine system and combined oral contraceptives at 6 or 12 months.
Further reading: A randomized trial comparing the 52-mg levonorgestrel system to combination oral contraceptives for the treatment of heavy menstrual bleeding. https://doi.org/10.1016/j.ajog.2023.07.049
