Conditions: Contraception
Keywords: Contraception Naproxen Intrauterine devices Pain Control
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 119
Healthy volunteers: yes

Brief summary:
The purpose of this study is:

1. To evaluate whether 550 mg of naproxen sodium reduces pain scores with IUD insertion on a 0-10cm visual analogue scale compared to placebo (primary outcome).
2. To evaluate whether 550 mg of naproxen sodium reduces pain scores with tenaculum placement, uterine sounding and post-procedurally on a 0-10 cm visual analog scale compared to placebo (secondary outcomes).
3. To establish if prophylactic naproxen sodium is acceptable for routine use prior to IUD insertion.

Hypothesis: The administration of naproxen sodium, 550mg orally, 1 hour prior to IUD insertion will lead to a reduction in pain scores associated with IUD insertion compared to placebo.

Detailed description:

Arms:
arm 1: 550 mg naproxen sodium arm 2: Placebo

Interventions: intervention 1: Naproxen sodium intervention 2: Placebo tablet
Intervention descriptions: intervention 1: 550 mg, oral, on day 1. Number of Cycles: 1 intervention 2: None

Protocol document: