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Naproxen for Pain Control With Intrauterine Device Insertion

NCT02388191 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 119

Last updated 2017-06-22

Study results available
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Summary

The purpose of this study is:

1. To evaluate whether 550 mg of naproxen sodium reduces pain scores with IUD insertion on a 0-10cm visual analogue scale compared to placebo (primary outcome).
2. To evaluate whether 550 mg of naproxen sodium reduces pain scores with tenaculum placement, uterine sounding and post-procedurally on a 0-10 cm visual analog scale compared to placebo (secondary outcomes).
3. To establish if prophylactic naproxen sodium is acceptable for routine use prior to IUD insertion.

Hypothesis: The administration of naproxen sodium, 550mg orally, 1 hour prior to IUD insertion will lead to a reduction in pain scores associated with IUD insertion compared to placebo.

Conditions

  • Contraception

Interventions

DRUG

Naproxen sodium

550 mg, oral, on day 1. Number of Cycles: 1

OTHER

Placebo tablet

Sponsors & Collaborators

  • Planned Parenthood League of Massachusetts

    lead OTHER

Principal Investigators

  • Principal Investigator, MD, MPH · PPLM

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2016-04-30
Completion
2016-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02388191 on ClinicalTrials.gov