5% Lidocaine Ointment in the Treatment of Vulvar Vestibulitis

This study has been terminated.
(lack of funding)
Sponsor:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00450242
First received: March 21, 2007
Last updated: June 12, 2012
Last verified: June 2012
  Purpose
  • 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 Intervention Phase
Vulvar Vestibulitis
Drug: 5% topical lidocaine ointment
Drug: Placebo cream
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Use of 5% Lidocaine Ointment in the Treatment of Vulvar Vestibulitis

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Number of Participants Who Report the Ability to Have Intercourse [ Time Frame: baseline, week 8 ] [ Designated as safety issue: No ]
    Participants' response upon inquiry.

  • Change in Visual Analog Scale (VAS) Scores With Intercourse From Baseline to Week 8 [ Time Frame: baseline, week 8 ] [ Designated as safety issue: No ]
    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:
  • SF-12 Quality of Life Scores [ Time Frame: baseline, week 8 ] [ Designated as safety issue: No ]
    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.

  • Modified Gracely Pain Scale [ Time Frame: baseline, week 8 ] [ Designated as safety issue: No ]
    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).


Enrollment: 14
Study Start Date: December 2006
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00450242

Locations
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
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
  More Information

No publications provided

Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00450242     History of Changes
Other Study ID Numbers: 05-2332
Study First Received: March 21, 2007
Results First Received: February 27, 2012
Last Updated: June 12, 2012
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by University of North Carolina, Chapel Hill:
vulvar vestibulitis
vestibulitis

Additional relevant MeSH terms:
Vulvar Vestibulitis
Vulvitis
Vulvar Diseases
Genital Diseases, Female
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014