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Vulvar Vestibulitis Clinical Trial: Desipramine-Lidocaine
This study has been completed.
First Received: January 11, 2006   Last Updated: November 12, 2007   History of Changes
Sponsor: University of Rochester
Information provided by: University of Rochester
ClinicalTrials.gov Identifier: NCT00276068
  Purpose

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.


Condition Intervention
Vulvar Disease
Drug: topical lidocaine + oral desipramine, and/or placebo

Study Type: Interventional
Study Design: Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Vulvar Vestibulitis Trial: Desipramine-Lidocaine

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • 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). [ Time Frame: 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 Outcome Measures:
  • 24 hour mean pain score [ Time Frame: Weeks (10, 11, and 12) from Weeks (-2, -1 and 0) ]
  • frequency of intercourse [ Time Frame: Weeks (10, 11, and 12) from Weeks (-2, -1 and 0) ]
  • intensity of intercourse pain [ Time Frame: 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
  • side-effects [ Time Frame: The subject sample analyzed for drug safety/side effects will include all subjects who have taken at least one dose of study drug. ]
  • Interleukin 1 RA and MC1-R polymorphisms

Estimated Enrollment: 128
Study Start Date: August 2002
Study Completion Date: September 2007
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria: Candidates must report greater than three continuous months' duration of vulvar symptoms of insertional dyspareunia, pain with tampon insertion, or pain to touch.

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.

Exclusion Criteria:

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.

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  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00276068

Locations
United States, New York
Strong Memorial Hospital
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: David C Foster, MD, MPH University of Rochester School of Medicine and Dentistry
  More Information

No publications provided by University of Rochester

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):
Study ID Numbers: 5 RO1 HD040123-03, 5 RO1 HD040123-03
Study First Received: January 11, 2006
Last Updated: November 12, 2007
ClinicalTrials.gov Identifier: NCT00276068     History of Changes
Health Authority: United States: Federal Government

Keywords provided by University of Rochester:
Vulvar vestibulitis
Vulvodynia
Desipramine
Lidocaine
Genetics

Additional relevant MeSH terms:
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Psychotropic Drugs
Anesthetics
Desipramine
Genital Diseases, Female
Vulvar Vestibulitis
Sensory System Agents
Therapeutic Uses
Vulvitis
Anti-Arrhythmia Agents
Antidepressive Agents
Lidocaine
Central Nervous System Depressants
Enzyme Inhibitors
Cardiovascular Agents
Pharmacologic Actions
Anesthetics, Local
Antidepressive Agents, Tricyclic
Peripheral Nervous System Agents
Central Nervous System Agents
Vulvar Diseases

ClinicalTrials.gov processed this record on November 27, 2009