Status:
COMPLETED
Vulvar Vestibulitis Clinical Trial: Desipramine-Lidocaine
Lead Sponsor:
University of Rochester
Conditions:
Vulvar Disease
Eligibility:
FEMALE
18-50 years
Phase:
NA
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: t...
Detailed Description
The Vulvar Vestibulitis Clinical Trial (VVCT) is a randomized, placebo-controlled, double-blinded clinical trial to study the clinical efficacy of four medical treatments for vulvar vestibulitis: 1) t...
Eligibility Criteria
Inclusion
- 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
- 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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Key Trial Info
Start Date :
August 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2007
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT00276068
Start Date
August 1 2002
End Date
September 1 2007
Last Update
November 14 2007
Active Locations (1)
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1
Strong Memorial Hospital
Rochester, New York, United States, 14642