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5% Lidocaine Ointment in the Treatment of Vulvar Vestibulitis

NCT00450242 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2012-07-16

Study results available
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Summary

* Study Hypothesis: Use of 5% topical lidocaine ointment will result in improved ability to have sexual intercourse and decreased pain scores in women with vestibulitis when compared to placebo.
* This is a study to assess if topical lidocaine will improve symptoms in women with vulvar vestibulitis. It compares use of nightly 5% topical lidocaine ointment to placebo ointment. The duration of the study is 8 weeks. 28 women will be in each arm for a total of 56 women in the study.

Conditions

  • Vulvar Vestibulitis

Interventions

DRUG

5% topical lidocaine ointment

Lidocaine 5% in hydrophilic petrolatum, dime-sized amount, applied nightly.

DRUG

Placebo cream

hydrophilic petrolatum, dime-sized amount, applied nightly.

Sponsors & Collaborators

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Jacqueline Rohl, MD · UNC Division of Advanced Laparoscopy and Pelvic Pain

  • Denniz Zolnoun, MD MPH · UNC- Division of Advanced Laparoscopy and Pelvic Pain

  • John Steege, MD · UNC Division of Advanced Laparoscopy and Pelvic Pain

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2009-01-31
Completion
2009-01-31

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 NCT00450242 on ClinicalTrials.gov