Vulvar Vestibulitis Clinical Trial
Official title:
Use of 5% Lidocaine Ointment in the Treatment of Vulvar Vestibulitis
- 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.
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of North Carolina | Chapel Hill | North Carolina |
Lead Sponsor | Collaborator |
---|---|
University of North Carolina, Chapel Hill |
United States,
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 |
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