Use of Ibuprofen to Prevent IUD Site Effects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

2019 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-06-30

Study Completion Date

2004-11-30

Brief Summary

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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

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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.

Conditions

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IUD Removal

Keywords

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randomized controlled trial prophylactic nonsteroidal antiflammatory drug IUD removal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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ibuprofen

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Principal Investigators

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David Hubacher, PhD

Role: PRINCIPAL_INVESTIGATOR

FHI 360

Locations

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43 Ministry of Health facilities

Santiago, , Chile

Site Status

Countries

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Chile

Other Identifiers

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9657

Identifier Type: -

Identifier Source: org_study_id