Vulvar Vestibulitis Clinical Trial: Desipramine-Lidocaine

• Status: Completed
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Rochester
• Treatments: Desipramine; Lidocaine

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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