Treatment of unacceptable bleeding in long-term users of 52-mg levonorgestrel intrauterine device: a prospective observational study

BACKGROUND

In the first month after the insertion of the 52-mg levonorgestrel intrauterine device, irregular vaginal bleeding often occurs. In 6% to 18% of 52-mg levonorgestrel intrauterine device users, irregular vaginal bleeding reoccurs or continues for more than 6 months after insertion of the device. This study hypothesized that the addition of estradiol may be beneficial for the regeneration of the endometrium and may consequently decrease irregular bleeding, as these basal vessels might be shielded by the regenerated endometrium.

OBJECTIVE

This prospective observational study aimed to evaluate the effectiveness of estradiol in treating irregular bleeding in patients who have had a 52-mg levonorgestrel intrauterine device in place for at least 6 months.

STUDY DESIGN

The study was conducted in 2 hospitals and in 1 general practice in the Netherlands. Patients with a 52-mg levonorgestrel intrauterine device who experienced irregular bleeding and who chose to undergo estradiol treatment were included. Treatment consisted of 2 mg of oral estradiol daily for 6 weeks. The primary outcome was the number of bleeding days a month after 3 months of estradiol treatment compared with baseline. The secondary outcomes included the number of bleeding days 12 months after the start of medication, bleeding patterns, discontinuation rate of the 52-mg levonorgestrel intrauterine device, side effects, adverse events, and patient satisfaction at 3 and 12 months of follow-up.

RESULTS

A total of 39 patients provided informed consent and completed the baseline questionnaires. The mean number of bleeding days decreased significantly from 22.5 days per month at baseline to 12.8 days per month 3 months after starting estradiol treatment. The 52-mg levonorgestrel intrauterine device was removed in 10.3% of patients at 3 months of follow-up and 33.3% of patients at 12 months of follow-up. The number of women reporting acceptable bleeding patterns and satisfaction with the 52-mg levonorgestrel intrauterine device increased substantially over 12 months of follow-up.

CONCLUSION

A decrease in the number of bleeding days was observed in long-term 52-mg levonorgestrel intrauterine device users who experienced unfavorable bleeding after the administration of estradiol for 6 weeks. In addition, satisfaction rates increased significantly.

Clinical trial registration number

NL8007