NCT00276068|CompletedDMC
Vulvar Vestibulitis Clinical Trial: Desipramine-Lidocaine
Vulvar Vestibulitis Trial: Desipramine-Lidocaine
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Vulvar Vestibulitis Trial: Desipramine-Lidocaine
Sponsor study identifier
Secondary identifiers
interventional
128
1 country
1
Study Start
August 2002
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
September 2007
Actual (reported)The Vulvar Vestibulitis Clinical Trial (VVCT) a randomized, placebo-controlled, double blinded clinical trial. We will study the clinical efficacy of four medical treatments for vulvar vestibulitis: topical lidocaine, oral desipramine, combined lidocaine and desipramine, and placebo cream and capsules. Desipramine is a tricyclic antidepressant commonly used by clinicians for treatment of several chronic pain conditions that demonstrates an optimal side effect profile compared to other tricyclic antidepressants. Topical lidocaine has also been found to be beneficial for vulvar vestibulitis treatment in small studies. It is hypothesized that the combined use of oral desipramine and topical lidocaine will be more therapeutically effective than either one by itself and better than placebo.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2007
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 2002
Date type not reportedThis date has not been verified as actual or estimated.
January 11, 2006
Actual (reported)January 12, 2006
Actual (reported)September 2007
Actual (reported)Primary outcome variable will compare the reported pain of the "Tampon Test" (mean of Weeks -2, -1, and 0), prior to randomization to the reported pain of "Tampon Test" (mean of Weeks 10, 11, and 12).
The dependent (primary outcome) variable will be defined as the percent change of mean "Tampon test" pain of Weeks (10, 11, and 12) from Weeks (-2, -1 and 0).
24 hour mean pain score
Weeks (10, 11, and 12) from Weeks (-2, -1 and 0)
frequency of intercourse
Weeks (10, 11, and 12) from Weeks (-2, -1 and 0)
intensity of intercourse pain
Weeks (10, 11, and 12) from Weeks (-2, -1 and 0)
selected psychometric tests
quantitative pain level measured by the Vulvar Algesiometer / Cotton Swab Test
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Strong Memorial Hospital
Rochester, New York, 14642, United States
Foster DC, Kotok MB, Huang LS, Watts A, Oakes D, Howard FM, Poleshuck EL, Stodgell CJ, Dworkin RH. Oral desipramine and topical lidocaine for vulvodynia: a randomized controlled trial. Obstet Gynecol. 2010 Sep;116(3):583-593. doi: 10.1097/AOG.0b013e3181e9e0ab.
Foster DC, Beth Kotok M, Huang LS, Watts A, Oakes D, Howard FM, Stodgell CJ, Dworkin RH. The tampon test for vulvodynia treatment outcomes research: reliability, construct validity, and responsiveness. Obstet Gynecol. 2009 Apr;113(4):825-832. doi: 10.1097/AOG.0b013e31819bda7c.
David C Foster, MD, MPH
University of Rochester
First Submitted
January 11, 2006
First Posted
January 12, 2006
Study Start
August 2002
Date type not reportedThis date has not been verified as actual or estimated.
Study Completion
September 2007
Actual (reported)Phase I/II Randomized, Placebo-Controlled Study of Capsaicin for Interstitial Cystitis and Vulvar Vestibulitis
Contact the study team to confirm eligibility.
Last Updated
November 14, 2007
Record last verified: 2007-11
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Source: ClinicalTrials.gov.
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