5% Lidocaine Ointment in the Treatment of Vulvar Vestibulitis

Vulvar Vestibulitis Clinical Trial

Official title:

Use of 5% Lidocaine Ointment in the Treatment of Vulvar Vestibulitis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00450242
• Other study ID #: 05-2332
• Status: Terminated
• Phase: Phase 2
• First received: March 21, 2007
• Last updated: June 12, 2012
• Start date: December 2006
• Est. completion date: January 2009

Study information

• Verified date: June 2012
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Vulvar Vestibulitis

Intervention

Drug:
• 5% topical lidocaine ointment
Lidocaine 5% in hydrophilic petrolatum, dime-sized amount, applied nightly.
• Placebo cream
hydrophilic petrolatum, dime-sized amount, applied nightly.

Locations

Country	Name	City	State
United States	University of North Carolina	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Report the Ability to Have Intercourse	Participants' response upon inquiry.	baseline, week 8	No
Primary	Change in Visual Analog Scale (VAS) Scores With Intercourse From Baseline to 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.	baseline, week 8	No
Secondary	SF-12 Quality of Life Scores	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.	baseline, week 8	No
Secondary	Modified Gracely Pain Scale	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).	baseline, week 8	No