Viewing Study NCT00243815



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Last Modification Date: 2024-10-26 @ 9:20 AM
Study NCT ID: NCT00243815
Status: COMPLETED
Last Update Posted: 2006-10-17
First Post: 2005-10-24

Brief Title: Use of Ibuprofen to Prevent IUD Site Effects
Sponsor: FHI 360
Organization: FHI 360

Study Overview

Official Title: Prophylactic Ibuprofen Effect on IUD Continuation Rates
Status: COMPLETED
Status Verified Date: 2005-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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 2019 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None