Use of Ibuprofen to Prevent IUD Site Effects
Launched by FHI 360 · Oct 24, 2005
Trial Information
Current as of May 15, 2025
Completed
Keywords
ClinConnect Summary
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 cyc...
Gender
FEMALE
Eligibility 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
About Fhi 360
FHI 360 is a nonprofit organization dedicated to improving lives worldwide through integrated and evidence-based approaches in health, education, and development. With a strong emphasis on research and innovation, FHI 360 conducts clinical trials that aim to advance public health outcomes, particularly in areas such as reproductive health, infectious diseases, and health systems strengthening. By collaborating with governments, NGOs, and local communities, FHI 360 strives to implement effective solutions that address complex global challenges, ensuring that interventions are sustainable and culturally appropriate. Their commitment to rigorous scientific inquiry and ethical standards positions them as a trusted leader in the field of global health research.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Santiago, , Chile
Patients applied
Trial Officials
David Hubacher, PhD
Principal Investigator
FHI 360
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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