NCT00243815

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,019

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jun 2002

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2002

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2004

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 25, 2005

Completed
Last Updated

October 17, 2006

Status Verified

October 1, 2005

First QC Date

October 24, 2005

Last Update Submit

October 16, 2006

Conditions

IUD Removal

Keywords

randomized controlled trialprophylactic nonsteroidal antiflammatory drugIUD removal

Outcome Measures

Primary Outcomes (1)

  • IUD removal

Secondary Outcomes (1)

  • Incidence of IUD side effects

Interventions

ibuprofenDRUG

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

43 Ministry of Health facilities

Santiago, Chile

Location

MeSH Terms

Interventions

Ibuprofen

Intervention Hierarchy (Ancestors)

PhenylpropionatesAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • David Hubacher, PhD

    FHI 360

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 24, 2005

First Posted

October 25, 2005

Study Start

June 1, 2002

Study Completion

November 1, 2004

Last Updated

October 17, 2006

Record last verified: 2005-10

Locations

CL(1)