Use of Ibuprofen to Prevent IUD Site Effects
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Primary Purpose: Prevention
|Official Title:||Prophylactic Ibuprofen: Effect on IUD Continuation Rates|
- IUD removal
- Incidence of IUD side effects
|Study Start Date:||June 2002|
|Estimated Study Completion Date:||November 2004|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00243815
|43 Ministry of Health facilities|
|Principal Investigator:||David Hubacher, PhD||FHI 360|