Use of Ibuprofen to Prevent IUD Site Effects

Phase 3

Completed

• Conditions: IUD Removal

• Registration Number: NCT00243815
• Lead Sponsor: FHI 360

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 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.

Study Timeline

• Study Start: 2002-06
• Study Completion: 2004-11
• Status Verified: 2005-10
• Study First Submitted: 2005-10-24
• Study First Submitted QC: 2005-10-24
• Study First Posted: 2005-10-25
• Last Update Submitted: 2006-10-16
• Last Update Posted: 2006-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 2019

Inclusion Criteria

• mutually monogamous sexual relationship, less than 6 weeks since last menstrual period, more than six weeks since last pregnancy ended, residency within 50km of clinic, access to telephone, literacy

Exclusion Criteria

• previous use of an IUD, history of liver and/or kidney disease, current of non-steroidal anti-inflammatory drugs, history of stomach ulcers and/or digestive hemorrhage, previous adverse reaction to ibuprofen and/or aspirin, symptoms of possible vaginal infection, current use of antibiotic or antifungal for genital tract infection, abnormal vaginal discharge, lesions in the vagina, known contraindication to IUD use, more than 3 alcoholic drinks per day

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
IUD removal

Secondary Outcome Measures

Name	Time	Method
Incidence of IUD side effects

Trial Locations

Locations (1)

43 Ministry of Health facilities; 🇨🇱 Santiago, Chile