CClinicalTrials.gg
Sign In
CompletedNCT00243815Updated Oct 17, 2006

Use of Ibuprofen to Prevent IUD Site Effects

A Phase 3 interventional study of ibuprofen in IUD Removal, sponsored by FHI 360. Completed at 1 site in Chile. Open to female participants aged 18 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2006-10-17.

Sponsored by FHI 360 · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
2,019
Allocation
Randomized
Ages
18 Years to 49 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • IUD Removal

Keywords

  • randomized controlled trial
  • prophylactic nonsteroidal antiflammatory drug
  • IUD removal
03

In context

Lead sponsor

FHI 360 is the lead sponsor of 56 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 49 Years
Sexes eligible
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

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
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Single group
Masking
Double
Enrollment
2,019 participants

Interventions

  • Drugibuprofen
06

What researchers measure

Primary outcomes

  1. IUD removal

Secondary outcomes

  1. Incidence of IUD side effects

07

Study locations

1 site
  • 43 Ministry of Health facilities
    Santiago, Chile
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 17, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00243815
Lead sponsor
FHI 360
Collaborators
Chilean Institute of Reproductive Medicine, Ministry of Health, Chile
First posted
Oct 25, 2005
Start date
Jun 2002
Completion
Nov 2004
Last update
Oct 17, 2006

Study contacts

David Hubacher, PhD
principal investigator · FHI 360
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2005. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

FHI 360

Start the discussion