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NCT01445756 · ClinicalTrials.gov registry record · Early Phase 1

Topical Lidocaine for Pain Control With Intrauterine Device (IUD) Insertion

A Early Phase 1 study of Pain, sponsored by University of Wisconsin, Madison.

Completed
Registry status
Early Phase 1
Development phase
40
Enrollment target
1
Study location

NCT01445756 is a Early Phase 1 study of Pain that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 40 participants, below the 304-participant average among 374 other Pain trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01445756, a Early Phase 1 study of Pain, has completed, sponsored by University of Wisconsin, Madison.

COMPLETED
Registry status
Early Phase 1
Development phase
40 participants
Enrollment target
1
Study location

Study Summary

Intrauterine contraception is a very effective, long term, reversible form of birth control, and is increasingly used in young, nulliparous patients. However, there is potential for pain with insertion of an Intrauterine Device (IUD) - particularly in patients without a previous history of vaginal delivery. The potential pain associated with insertion is often a significant barrier for patients when choosing and IUD for contraception. Several methods of pain control have been studied, but none have been shown to reduce pain at time of insertion. Our research question is to determine if 2% topical lidocaine gel, instilled into the cervical canal, will reduce maximum pain at time of insertion of a popular IUD (Mirena Intrauterine System) in young, nulliparous patients. This will be studied in a randomized, double-blind placebo-controlled trial.

Conditions Studied

Pain

Interventions

  • DRUG Placebo
  • DRUG Lidocaine

Study Locations (1)

Wisconsin

  • University Health Services Women's Care Clinic - Madison

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2010-07
Est. Completion 2011-06
Phase Early Phase 1

Sponsor

University of Wisconsin, Madison

1,039 total trials

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What the Registry Record Tells You About NCT01445756

The ClinicalTrials.gov registry entry for NCT01445756 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 304-participant average among 374 other Pain trials with a reported enrollment target (87% lower). The listed sponsor is University of Wisconsin, Madison, which has 1,039 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Pain appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT01445756 reports 1 study location spanning 1 distinct geographic area - top geographies include Wisconsin.

Frequently Asked Questions

What is clinical trial NCT01445756 about?

NCT01445756 is a clinical study titled "Topical Lidocaine for Pain Control With Intrauterine Device (IUD) Insertion". Intrauterine contraception is a very effective, long term, reversible form of birth control, and is increasingly used in young, nulliparous patients. However, there is potential for pain with insertion of an Intrauterine Device (IUD) - particularly in patients without a previous history of vaginal d...

What is the current status of trial NCT01445756?

This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 40 participants. The study started on 2010-07. Estimated completion is 2011-06.

What conditions does trial NCT01445756 study?

This clinical trial studies the following conditions: Pain.

What interventions are being tested in trial NCT01445756?

The interventions under investigation include: Placebo (DRUG), Lidocaine (DRUG).

Who is sponsoring clinical trial NCT01445756?

This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01445756 being conducted?

This trial has 1 study location across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.