|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| 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 |
| 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 |
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.
-
Contacts and Locations| United States, New York | |
| Strong Memorial Hospital | |
| Rochester, New York, United States, 14642 | |
| Principal Investigator: | David C Foster, MD, MPH | University of Rochester School of Medicine and Dentistry |
More Information
| 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 |
|
Vulvar vestibulitis Vulvodynia Desipramine Lidocaine Genetics |
|
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 |