Copper IUD Treatment Observation Study
Condition: Menorrhagia
MeSH terms: Menorrhagia
Intervention: Naproxen; Placebo
Intervention description: Naproxen 440mg 1x pid; Placebo tablet 440mg 1x pid
Intervention MeSH terms: Naproxen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 34.0
Sex: Female
Minimum age: 18 Years
Maximum age: 49 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: IUD; naproxen; bleeding

Summary:

      Studies indicate that bleeding irregularities and dysmenorrhea are common reasons for copper
      IUD method discontinuation. Some evidence suggests that non-steroidal anti-inflammatory
      medications (NSAIDs) can help improve bleeding during Cu-IUD use. However, these studies did
      not examine NSAID use with the TCu380A specifically, nor did they evaluate readily available
      NSAIDs such as over-the-counter naproxen. For this reason, the investigators propose a pilot
      trial in which new TCu380A users complaining of heavy or prolonged menstrual bleeding or
      spotting after 1 month of use are randomized to naproxen or placebo to be taken the first 7
      days of menstruation for three consecutive cycles, and then observed for one cycle without
      treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  • Age ≥ 18 and < 49 years. We are including a wide range of ages because women of all
             ages request TCu380A. While we recognize that some women approaching menopause (median
             age = 51.4 years) may have changes in their baseline menstruation, we trust that
             clinicians enrolling the patients into the study will ensure that these women meet all
             inclusion (i.e., regular cycles) and exclusion criteria (i.e., do not have diagnosis
             of menorrhagia).

               -  Requesting to have TCu380A IUD inserted as contraceptive method.

               -  English-speaking.

               -  Regular menstrual cycles ranging 21-35 days apart.

               -  Generally healthy.

               -  Willing to attend a 4- to 6-week follow-up visit and complete surveys.

        Exclusion Criteria:

          -  Known or suspected pregnancy.

               -  Contraindications to NSAID use. This includes underlying heart failure, chronic
                  renal disease, chronic liver disease, peptic ulcer disease, or history of upper
                  gastrointestinal bleed, and allergy to NSAIDs.

               -  Current regular use of a NSAID.

               -  Unwilling to avoid use of NSAIDs (except for study medication) for the duration
                  of the study.

               -  Current diagnosis of menorrhagia, metrorrhagia, symptomatic uterine fibroids, or
                  endometrial polyps.

               -  Use of depot medroxyprogesterone acetate (DMPA) or levonorgestrel-releasing
                  intrauterine device (LNG IUD) within the previous 3 months.

               -  Postpartum in the past 4 weeks. The average day in which non-breastfeeding
                  postpartum women ovulate is 25 days after birth, indicating that menstrual cycles
                  can resume after the 4th postpartum week.

               -  Existing medical condition for which placement of TCu380A IUD is a
                  contraindication according to the Centers for Disease Control and Prevention
                  Medical Eligibility Criteria (MEC 4 medical conditions; see Appendix A).

               -  Currently breastfeeding.

               -  Previous use of the TCu380A.