5% Lidocaine Ointment in the Treatment of Vulvar Vestibulitis

NCT ID: NCT00450242

Last Updated: 2012-07-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-12-31
• Study Completion Date: 2009-01-31

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.

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.

Conditions

Vulvar Vestibulitis

Keywords

vulvar vestibulitis; vestibulitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

5% Lidocaine cream

5% topical lidocaine cream.

Group Type: EXPERIMENTAL

5% topical lidocaine ointment

Intervention Type: DRUG

Lidocaine 5% in hydrophilic petrolatum, dime-sized amount, applied nightly.

Placebo cream

Group Type: PLACEBO_COMPARATOR

Placebo cream

Intervention Type: DRUG

hydrophilic petrolatum, dime-sized amount, applied nightly.

Interventions

5% topical lidocaine ointment

Lidocaine 5% in hydrophilic petrolatum, dime-sized amount, applied nightly.

Intervention Type: DRUG

Placebo cream

hydrophilic petrolatum, dime-sized amount, applied nightly.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jacqueline Rohl, MD

Role: STUDY_DIRECTOR

UNC Division of Advanced Laparoscopy and Pelvic Pain

Denniz Zolnoun, MD MPH

Role: PRINCIPAL_INVESTIGATOR

UNC- Division of Advanced Laparoscopy and Pelvic Pain

John Steege, MD

Role: STUDY_CHAIR

UNC Division of Advanced Laparoscopy and Pelvic Pain

Locations

University of North Carolina

Chapel Hill, North Carolina, United States

Countries

United States

Other Identifiers

05-2332

Identifier Type: -

Identifier Source: org_study_id