Use of Ibuprofen to Prevent IUD Site Effects

This study has been completed.
Sponsor:
Collaborators:
Chilean Institute of Reproductive Medicine
Ministry of Health, Chile
Information provided by:
FHI 360
ClinicalTrials.gov Identifier:
NCT00243815
First received: October 24, 2005
Last updated: October 16, 2006
Last verified: October 2005
  Purpose

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 Intervention Phase
IUD Removal
Drug: ibuprofen
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Prophylactic Ibuprofen: Effect on IUD Continuation Rates

Resource links provided by NLM:


Further study details as provided by FHI 360:

Primary Outcome Measures:
  • IUD removal

Secondary Outcome Measures:
  • Incidence of IUD side effects

Estimated Enrollment: 2019
Study Start Date: June 2002
Estimated Study Completion Date: November 2004
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

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00243815

Locations
Chile
43 Ministry of Health facilities
Santiago, Chile
Sponsors and Collaborators
FHI 360
Chilean Institute of Reproductive Medicine
Ministry of Health, Chile
Investigators
Principal Investigator: David Hubacher, PhD FHI 360
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00243815     History of Changes
Other Study ID Numbers: 9657
Study First Received: October 24, 2005
Last Updated: October 16, 2006
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on September 30, 2014