Use of Ibuprofen to Prevent IUD Site Effects

IUD Removal Clinical Trial

Official title:

Prophylactic Ibuprofen: Effect on IUD Continuation Rates

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00243815
• Other study ID #: 9657
• Status: Completed
• Phase: Phase 3
• First received: October 24, 2005
• Last updated: October 16, 2006
• Start date: June 2002
• Est. completion date: November 2004

Study information

• Verified date: October 2005
• Source: FHI 360
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2019
• Est. completion date: November 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• IUD Removal

Intervention

Drug:
• ibuprofen

Locations

Country	Name	City	State
Chile	43 Ministry of Health facilities	Santiago

Sponsors (3)

Lead Sponsor	Collaborator
FHI 360	Chilean Institute of Reproductive Medicine, Ministry of Health, Chile

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IUD removal
Secondary	Incidence of IUD side effects