5% Lidocaine Ointment in the Treatment of Vulvar Vestibulitis

Brief Title

5% Lidocaine Ointment in the Treatment of Vulvar Vestibulitis

Official Title

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

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.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Number of Participants Who Report the Ability to Have Intercourse

Secondary Outcome

 SF-12 Quality of Life Scores

Condition

Vulvar Vestibulitis

Intervention

5% topical lidocaine ointment

Study Arms / Comparison Groups

 5% Lidocaine cream
Description:  5% topical lidocaine cream.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

14

Start Date

December 2006

Completion Date

January 2009

Primary Completion Date

January 2009

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
      

Gender

Female

Ages

18 Years - 50 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Jacqueline Rohl, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00450242

Organization ID

05-2332


Responsible Party

Sponsor

Study Sponsor

University of North Carolina, Chapel Hill


Study Sponsor

Jacqueline Rohl, MD, Study Director, UNC Division of Advanced Laparoscopy and Pelvic Pain


Verification Date

June 2012