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5% Lidocaine Ointment in the Treatment of Vulvar Vestibulitis

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. Identifier: NCT00450242
Recruitment Status : Terminated (lack of funding)
First Posted : March 22, 2007
Results First Posted : July 16, 2012
Last Update Posted : July 16, 2012
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief Summary:
  • Study Hypothesis: Use of 5% topical lidocaine ointment will result in improved ability to have sexual intercourse and decreased pain scores in women with vestibulitis when compared to placebo.
  • This is a study to assess if topical lidocaine will improve symptoms in women with vulvar vestibulitis. It compares use of nightly 5% topical lidocaine ointment to placebo ointment. The duration of the study is 8 weeks. 28 women will be in each arm for a total of 56 women in the study.

Condition or disease Intervention/treatment Phase
Vulvar Vestibulitis Drug: 5% topical lidocaine ointment Drug: Placebo cream Phase 2

Detailed Description:
  • After consent is obtained patients will undergo the following treatment plan: randomization to treatment with 5% lidocaine ointment or placebo for vestibulitis. There will be 56 women total (28 in each arm).The placebo used will be hydrophilic petrolatum. Randomization will be performed using computer generated permuted blocks. A standard history and physical exam incorporating assessment of skin allodynia (testing with q-tip swab) on the vestibule and pressure measurements of the pelvic floor muscles (how much tenderness there is on perineal muscles with palpation) will be performed. Baseline questionnaires that will evaluate sexual frequency, sexual function survey (Female sexual function index), the modified Gracely pain scale of intercourse related pain, and psychometric evaluation including evaluation of anxiety, somatization (State-Trait Anxiety Inventory and Brief Symptom Inventory). Depression can also be evaluated with the Brief Symptom Inventory. Lastly, overall quality of health can be assessed with the SF-12. There is a baseline, 2 week and 6 week visit. Women will abstain from intercourse during these 6 weeks. Women will have a physical exam evaluation of the vestibule at each visit. They will then be able to have intercourse and will repeat surveys of sexual frequency, function, pain scale of intercourse related pain and the SF-12 at 8 weeks.
  • Aim 1: To assess if lidocaine ointment produces a superior treatment response to placebo.
  • Hypothesis 1: Use of topical lidocaine, compared with placebo, will result in improved sexual function and self-reported pain scores. This is to be measured as the ability to have successful intercourse. Secondarily, sexual function, quality of life and scores for intercourse related pain will be evaluated.
  • Aim 2: To assess if there are predictors of response to treatment such as demographics, duration of disease, primary or secondary vulvar vestibulitis, or psychometric assessments (anxiety and somatization).
  • Hypothesis 2: There are predictors of response to treatment of vulvar vestibulitis based upon patient characteristics, characteristics of the disease and psychometric assessments.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Use of 5% Lidocaine Ointment in the Treatment of Vulvar Vestibulitis
Study Start Date : December 2006
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Arm Intervention/treatment
Experimental: 5% Lidocaine cream
5% topical lidocaine cream.
Drug: 5% topical lidocaine ointment
Lidocaine 5% in hydrophilic petrolatum, dime-sized amount, applied nightly.

Placebo Comparator: Placebo cream Drug: Placebo cream
hydrophilic petrolatum, dime-sized amount, applied nightly.

Primary Outcome Measures :
  1. Number of Participants Who Report the Ability to Have Intercourse [ Time Frame: baseline, week 8 ]
    Participants' response upon inquiry.

  2. Change in Visual Analog Scale (VAS) Scores With Intercourse From Baseline to Week 8 [ Time Frame: baseline, week 8 ]
    Visual Analog Scale (VAS) scores (range 0-100 mm; 0 = none, 100 = worst pain) were recorded for pain during intercourse during baseline and week 8 of the study, for lidocaine treated subjects and controls. The "mean" listed for each group is average week 8 score subtracted from the average baseline score.

Secondary Outcome Measures :
  1. SF-12 Quality of Life Scores [ Time Frame: baseline, week 8 ]
    The SF-12 is a subset of 12 items from the Medical Outcomes Study 36-Item Short Form Survey (SF-36) and was collected at the bi-weekly office visits. Each score ranges from 0-100. The components measure physical and mental health, respectively. Higher scores are indicative of better function. ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, and age.

  2. Modified Gracely Pain Scale [ Time Frame: baseline, week 8 ]
    The Modified Gracely Pain Scale consists of two components: 1) three numerical scales scored 0-100 for lowest, average, and highest pain level during during the preceding week, and 2) two word choice scales measuring affective and intensity levels. Each word in the word choice scales has an assigned number. Change scores on each subscale can thus be calculated over time (baseline v. week 8).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • women with the clinical diagnosis of vvs who have dyspareunia as their primary complaint. They must have a current sexual partner.

Exclusion Criteria:

  • postmenopausal
  • pure vaginismus
  • generalized vulvodynia
  • pudendal neuralgia
  • pregnant, breastfeeding
  • less than 2 months post delivery
  • diagnosis of dermatologic condition on biopsy
  • positive fungal culture
  • currently on treatment for vvs
  • history of lidocaine treatment for vvs

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 identifier (NCT number): NCT00450242

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United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
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Study Director: Jacqueline Rohl, MD UNC Division of Advanced Laparoscopy and Pelvic Pain
Principal Investigator: Denniz Zolnoun, MD MPH UNC- Division of Advanced Laparoscopy and Pelvic Pain
Study Chair: John Steege, MD UNC Division of Advanced Laparoscopy and Pelvic Pain

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Responsible Party: University of North Carolina, Chapel Hill Identifier: NCT00450242     History of Changes
Other Study ID Numbers: 05-2332
First Posted: March 22, 2007    Key Record Dates
Results First Posted: July 16, 2012
Last Update Posted: July 16, 2012
Last Verified: June 2012
Keywords provided by University of North Carolina, Chapel Hill:
vulvar vestibulitis
Additional relevant MeSH terms:
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Vulvar Vestibulitis
Vulvar Diseases
Genital Diseases, Female
Anesthetics, Local
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