Use of Ibuprofen to Prevent IUD Site Effects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00243815
Recruitment Status : Completed
First Posted : October 25, 2005
Last Update Posted : October 17, 2006
Chilean Institute of Reproductive Medicine
Ministry of Health, Chile
Information provided by:
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.

Condition or disease Intervention/treatment Phase
IUD Removal Drug: ibuprofen Phase 3

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 Type : Interventional  (Clinical Trial)
Enrollment : 2019 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Prophylactic Ibuprofen: Effect on IUD Continuation Rates
Study Start Date : June 2002
Study Completion Date : November 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. IUD removal

Secondary Outcome Measures :
  1. Incidence of IUD side effects

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00243815

43 Ministry of Health facilities
Santiago, Chile
Sponsors and Collaborators
FHI 360
Chilean Institute of Reproductive Medicine
Ministry of Health, Chile
Principal Investigator: David Hubacher, PhD FHI 360 Identifier: NCT00243815     History of Changes
Other Study ID Numbers: 9657
First Posted: October 25, 2005    Key Record Dates
Last Update Posted: October 17, 2006
Last Verified: October 2005

Keywords provided by FHI 360:
randomized controlled trial
prophylactic nonsteroidal antiflammatory drug
IUD removal

Additional relevant MeSH terms:
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action