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Vulvar Vestibulitis Clinical Trial: Desipramine-Lidocaine

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ClinicalTrials.gov Identifier: NCT00276068
Recruitment Status : Completed
First Posted : January 12, 2006
Last Update Posted : November 14, 2007
Sponsor:
Information provided by:
University of Rochester

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.

Condition or disease Intervention/treatment Phase
Vulvar Disease Drug: topical lidocaine + oral desipramine, and/or placebo Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Official Title: Vulvar Vestibulitis Trial: Desipramine-Lidocaine
Study Start Date : August 2002
Actual Study Completion Date : September 2007





Primary Outcome Measures :
  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). [ 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 :
  1. 24 hour mean pain score [ Time Frame: Weeks (10, 11, and 12) from Weeks (-2, -1 and 0) ]
  2. frequency of intercourse [ Time Frame: Weeks (10, 11, and 12) from Weeks (-2, -1 and 0) ]
  3. intensity of intercourse pain [ Time Frame: Weeks (10, 11, and 12) from Weeks (-2, -1 and 0) ]
  4. selected psychometric tests
  5. quantitative pain level measured by the Vulvar Algesiometer / Cotton Swab Test
  6. 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. ]
  7. Interleukin 1 RA and MC1-R polymorphisms


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes 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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00276068


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00276068     History of Changes
Other Study ID Numbers: 5R01HD040123-03 ( U.S. NIH Grant/Contract )
5R01HD040123-03 ( U.S. NIH Grant/Contract )
First Posted: January 12, 2006    Key Record Dates
Last Update Posted: November 14, 2007
Last Verified: November 2007

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

Additional relevant MeSH terms:
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Vulvar Vestibulitis
Vulvar Diseases
Vulvitis
Genital Diseases, Female
Lidocaine
Desipramine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Enzyme Inhibitors
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Agents