Use of Ibuprofen to Prevent IUD Site Effects

Prophylactic Ibuprofen: Effect on IUD Continuation Rates

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00243815

Enrollment

2019

Registered

2005-10-25

Start date

2002-06-30

Completion date

2004-11-30

Last updated

2006-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IUD Removal

Keywords

randomized controlled trial, prophylactic nonsteroidal antiflammatory drug, IUD removal

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 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.

Interventions

DRUGibuprofen

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

DOUBLE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 49 Years

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

Design outcomes

Primary

Measure	Time frame
IUD removal	—

Secondary

Measure	Time frame
Incidence of IUD side effects	—

Countries

Chile

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026