5% Lidocaine Ointment in the Treatment of Vulvar Vestibulitis - Full Text View

Sponsored by:	University of North Carolina
Information provided by:	The University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:	NCT00450242

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	Phase II

Drug Information available for: Lidocaine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study
Official Title:	Use of 5% Lidocaine Ointment in the Treatment of Vulvar Vestibulitis

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

Primary Outcome Measures:

ability to have intercourse
pain scores with intercourse

Secondary Outcome Measures:

SF-12 quality of life scores

Estimated Enrollment:	56
Study Start Date:	December 2006
Estimated Study Completion Date:	April 2008

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

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

Contacts

Contact: Grace Fulton, BS	919 966-8202 ext 226	grace_fulton@med.unc.edu
Contact: Jacqueline Rohl, MD	919 966-8202 ext 285	jrohl@med.unc.edu

Locations

United States, North Carolina
University of North Carolina	Recruiting
Chapel Hill, North Carolina, United States, 27599

Sponsors and Collaborators

University of North Carolina

Investigators

Principal Investigator:	Jacqueline Rohl, MD	UNC Division of Advanced Laparoscopy and Pelvic Pain
Study Director:	Denniz Zolnound, MD	UNC- Division of Advanced Laparoscopy and Pelvic Pain

More Information

Study ID Numbers:	05-2332
Study First Received:	March 21, 2007
Last Updated:	March 21, 2007
ClinicalTrials.gov Identifier:	NCT00450242
Health Authority:	United States: Institutional Review Board

Keywords provided by The University of North Carolina, Chapel Hill:

vulvar vestibulitis
vestibulitis

Study placed in the following topic categories:

Genital Diseases, Female
Vulvar Vestibulitis
Lidocaine
Vulvar Vestibulitis Syndrome
Vulvar Diseases

Additional relevant MeSH terms:

Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Depressants
Anesthetics
Cardiovascular Agents

Anti-Arrhythmia Agents
Peripheral Nervous System Agents
Vulvitis
Central Nervous System Agents
Pharmacologic Actions
Anesthetics, Local

ClinicalTrials.gov processed this record on January 14, 2009