5% Lidocaine Ointment in the Treatment of Vulvar Vestibulitis
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Vulvar Vestibulitis
In brief
* 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.
Key facts
- Study ID
- NCT00450242
- Run by
- University of North Carolina, Chapel Hill
- People needed
- 14
- Starts
- 2006-12-01
- Expected to finish
- 2009-01-01
- Last updated by the study team
- 2012-07-16
Who can join
Age: 18 and older, up to 50. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- women with the clinical diagnosis of vvs who have dyspareunia as their primary complaint. They must have a current sexual partner.
You may not qualify if…
- 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
Where it is running
- University of North Carolina — Chapel Hill, North Carolina, United States
Full record on ClinicalTrials.gov
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