Vulvar Vestibulitis Clinical Trial: Desipramine-Lidocaine
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00276068 |
Recruitment Status :
Completed
First Posted : January 12, 2006
Last Update Posted : November 14, 2007
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Vulvar Disease | Drug: topical lidocaine + oral desipramine, and/or placebo | Not Applicable |

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 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). ]
- 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes 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.
-

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
United States, New York | |
Strong Memorial Hospital | |
Rochester, New York, United States, 14642 |
Principal Investigator: | David C Foster, MD, MPH | University of Rochester |
ClinicalTrials.gov Identifier: | NCT00276068 |
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 |
Vulvar vestibulitis Vulvodynia Desipramine Lidocaine Genetics |
Vulvar Vestibulitis Vulvar Diseases Vulvitis 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 |