Status:
TERMINATED
5% Lidocaine Ointment in the Treatment of Vulvar Vestibulitis
Lead Sponsor:
University of North Carolina, Chapel Hill
Conditions:
Vulvar Vestibulitis
Eligibility:
FEMALE
18-50 years
Phase:
PHASE2
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. * Thi...
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 e...
Eligibility Criteria
Inclusion
- women with the clinical diagnosis of vvs who have dyspareunia as their primary complaint. They must have a current sexual partner.
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00450242
Start Date
December 1 2006
End Date
January 1 2009
Last Update
July 16 2012
Active Locations (1)
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1
University of North Carolina
Chapel Hill, North Carolina, United States, 27599