Copper IUD Treatment Observation Study
Condition: Menorrhagia
MeSH terms: Menorrhagia
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      The Copper IUD (Cu-IUD) is the most widely used IUD in the world, and its use in the United
      States (US) is on the rise. The Cu-IUD is considered one of the most effective contraception
      methods, being as effective as permanent sterilization but having the convenience of being
      reversible should a woman decide to conceive.2 The Copper 380A (TCu380A) is the only Cu-IUD
      available in the US; of all Cu-IUDs, the TCu380A is considered the most effective. Despite
      its increasing popularity in the US, studies indicate that bleeding irregularities and
      dysmenorrhea are common reasons for 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. The number of bleeding/spotting days will be
      compared using Student t-test. In addition to assessing how well naproxen reduces incidence
      and amount of bleeding, the investigators will also assess the use of naproxen and TCu380A on
      quality of life, sexual function, method satisfaction, menstrual pain, and adverse events. By
      measuring these variables, the investigators will assess both positive and negative
      consequences of TCu380A use, ensuring that harm does not outweigh benefits.
    

Intervention name(s): Naproxen; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Naproxen 440mg 1x pid; Placebo tablet 440mg 1x pid
Other intervention name(s): Intervention; Control
Intervention MeSH terms: Naproxen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: IUD; naproxen; bleeding