Status:
COMPLETED
Use of Ibuprofen to Prevent IUD Site Effects
Lead Sponsor:
FHI 360
Collaborating Sponsors:
Chilean Institute of Reproductive Medicine
Ministry of Health, Chile
Conditions:
IUD Removal
Eligibility:
FEMALE
18-49 years
Phase:
PHASE3
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 pr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2002
Trial Type :
INTERVENTIONAL
End Date :
November 1 2004
Estimated Enrollment :
2019 Patients enrolled
Trial Details
Trial ID
NCT00243815
Start Date
June 1 2002
End Date
November 1 2004
Last Update
October 17 2006
Active Locations (1)
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1
43 Ministry of Health facilities
Santiago, Chile