NCT00243815

Use of Ibuprofen to Prevent IUD Site Effects

Prophylactic Ibuprofen: Effect on IUD Continuation Rates

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,019 (planned)
• Sponsor: FHI 360 · Academic / Other
• Sex: Female
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

Summary

This research will determine whether prophylactic use of ibuprofen can prevent common side effects of the copper intrauterine device (IUD) and prevent early removal of the device.

Detailed description

Increased menstrual bleeding and pain are the primary side effects that lead to early removal of the copper intrauterine device (IUD). Ibuprofen and other nonsteroidal anti-inflammatory drugs are a proven treatment for such IUD-induced problems. This study will determine if prophylactic use of ibuprofen can improve continuation rates of the IUD. A total of 2,019 first-time IUD users were recruited in Chile for this double-blind, randomized, placebo-controlled trial. Half of the participants were given ibuprofen and instructions to take 1200 mg daily during menses (for up to 5 days each cycle) for the first six months of IUD use. The other half were asked to take an identical-appearing placebo in the same manner. The primary study endpoint was IUD removal within 12 months of insertion.

Conditions

• IUD Removal

Interventions

Type	Name	Description
DRUG	ibuprofen

Timeline

• Start date: 2002-06-01
• Completion: 2004-11-01
• First posted: 2005-10-25
• Last updated: 2006-10-17

Locations

1 site across 1 country: Chile