Use of Ibuprofen to Prevent IUD Site Effects
Information source: Family Health International
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: IUD Removal
Intervention: ibuprofen (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Family Health International Official(s) and/or principal investigator(s):
David Hubacher, PhD, Principal Investigator, Affiliation: Family Health International
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.
Clinical Details
Official title: Prophylactic Ibuprofen: Effect on IUD Continuation Rates
Study design: Prevention, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study
Primary outcome: IUD removal
Secondary outcome: Incidence of IUD side effects
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 49 Years.
Gender(s): Female.
Criteria:
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
Locations and Contacts
43 Ministry of Health facilities, Santiago, Chile
Additional Information
Starting date: June 2002
Ending date: November 2004
Last updated: October 16, 2006
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