Background: The most common reason women report discontinued use of the Copper T 380A (TCu380A) IUD is because of bleeding irregularities after method initiation. The objective of this study was to determine whether an over-the-counter NSAID, naproxen sodium, reduces the number of bleeding and spotting days and heavy or prolonged bleeding episodes among new users of the TCu380A IUD compared to placebo.Methods: In this double-blind pilot trial, we randomized 28 new TCu380A IUD users who reported menstrual cycle changes within 4-6 weeks after IUD placement to either naproxen 440 mg or placebo twice daily for 7 days for three consecutive 28-day cycles and one additional 28-day cycle without treatment. Participants completed a daily bleeding and other symptom diary, and monthly questionnaires. Results: Although not statistically significant, participants in the naproxen arm reported more mean number of spotting-only days during the three treatment cycles compared those in the placebo group (13.5 days (SE 5.1) vs.7.5 days (SE 1.7), respectively). Otherwise, the mean number of bleeding-only days during treatment and post-treatment and spotting-only post-treatment were similar between the groups. During each treatment cycle, fewer participants in the treatment group reported heavy bleeding compared to placebo group (30.7% fewer in cycle 2; 5.4% fewer in cycle 3). More women in the treatment group, however, reported prolonged menstrual bleeding of greater than 7 days for each cycle, although the percentage reporting prolonged bleeding decreased each consecutive treatment and post-treatment cycle (+27.5%, +19.8%, +9.1%, +4.5%, cycles 1-4 respectively). Other symptoms experienced by new TCu380A users did not differ between the study arms.Conclusions: Treatment with naproxen did not significantly reduce the number of bleeding or spotting days among new TCu380A users. Although not statistically different, proportionally fewer participants in the naproxen group reported moderate-heavy or heavy periods, but more reported prolonged menstrual bleeding compared to placebo. Participants tolerated oral naproxen use well.Trial registration: ClinicalTrials.gov: NCT02519231. Registered on August 10 2015.