Vulvar Vestibulitis Clinical Trial: Desipramine-Lidocaine

NCT00276068 | Completed DMC

• 1 other identifier: 5R01HD040123-03
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vulvar Disease

Keywords

Vulvar vestibulitis; Vulvodynia; Desipramine; Lidocaine; Genetics

Outcome Measures

Primary Outcomes (1)

• 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).

Secondary Outcomes (7)

• 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

Interventions

topical lidocaine + oral desipramine, and/or placebo DRUG

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Physical exam should demonstrate "Friedrich's Criteria" which includes Criterion #1: history of severe pain on vestibular touch or attempted vaginal entry for a continuous duration of 6 months or greater. Criterion #2: tenderness localized within the vestibule.
• The candidate should not demonstrate any other specific neuropathology Pre-randomization laboratory testing should fail to identify atrophic vaginitis, dermatitis such as vulvar dystrophy, or pathogens such as fungus, or herpes.
• The candidate should not report use tricyclic-class or topical lidocaine within 30 days of the study.
• Candidates will need to be capable of keeping adequate records and demonstrate reliability in use of medication.
• If the candidate is premenopausal, adequate contraception will be necessary including oral contraceptives, barrier method, progestational contraceptives, vasectomy, tubal ligation, and hysterectomy.

You may not qualify if:

• History of cardiac arrhythmia, syncopal episodes, seizures, vulvar cancer, specific dermatoses, choreoathetosis or major depression.
• Active infection with herpes simplex, herpes zoster, Bartholin's abscess, Pregnancy, Active liver disease or renal disease, Evidence on prior vulvar biopsy or clinical impression of specific vulvar dermatoses such as lichen sclerosus, squamous cell hyperplasia, or lichen planus Positive culture for fungus (persistence of pain after treatment of particular infection and negative culture will not exclude subject from the study) Known hypersensitivity to either active agents (desipramine/lidocaine) or cream vehicle (Moisturelle cream) Immunocompromised state, History of illicit drug or alcohol abuse within the last year Serious or unstable medical or psychiatric conditions, Evidence of conduction abnormalities (especially prolonged QT interval) on ECG.

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

Strong Memorial Hospital

Rochester, New York, 14642, United States

Location

Related Publications (2)

• 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.

  PMID: 20733439 DERIVED

• 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.

  PMID: 19305326 DERIVED

MeSH Terms

Conditions

Vulvar Diseases; Vulvar Vestibulitis; Vulvodynia

Interventions

Lidocaine; Desipramine

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Vulvitis

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• David C Foster, MD, MPH

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 11, 2006
• First Posted: January 12, 2006
• Study Start: August 1, 2002
• Study Completion: September 1, 2007
• Last Updated: November 14, 2007

Record last verified: 2007-11

Locations

US (1)