5% Lidocaine Ointment in the Treatment of Vulvar Vestibulitis

• Status: Terminated
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of North Carolina, Chapel Hill
• Treatments: Lidocaine

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