Expired Study
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Boston, Massachusetts 02215


Purpose:

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.


Criteria:

Inclusion Criteria: - Age 18 years or older - Premenopausal - Presenting for insertion of any IUD type (i.e. Mirena, Paragard, Skyla) - English-speaking or non-English speaking with appropriate translator available Exclusion Criteria: - Currently pregnant or pregnant within the last 4 weeks - Not eligible for IUD insertion per PPLM's clinical protocols - Presenting for IUD removal and reinsertion - Any diagnosis of chronic pain (including fibromyalgia, endometriosis, dysmenorrhea, irritable bowel syndrome, interstitial cystitis) - Pain medications taken within 12 hours of enrollment - Misoprostol usage within 24 hours of enrollment - Any known allergy or contraindication to non-steroidal anti-inflammatory drugs (including active renal disease, active hepatic disease, gastric ulcer disease or gastritis, and bleeding disorders)


NCT ID:

NCT02388191


Primary Contact:

Principal Investigator
Principal Investigator, MD, MPH
PPLM


Backup Contact:

N/A


Location Contact:

Boston, Massachusetts 02215
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2017

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