NCT00496184

Efficacy Study of Topical Application of Nifedipine Cream to Treat Vulvar Vestibulitis

Topical Application of Nifedipine Cream for the Treatment of Vulvar Vestibulitis Syndrome

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Western Galilee Hospital-Nahariya · Other Government
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the use of topical application of Nifedipine cream for the treatment of Provoked localized Vulvodynia (vestibulitis, vestibulodynia).

Detailed description

30 women aged 18-45 diagnosed with Provoked localized Vulvodynia will be included. 10 women will use topical Nifedipine cream 0.2% 4 times a day for 6 weeks (except for menstrual period). 10 other women will use topical Nifedipine cream 0.4% 4 times a day for 6 weeks (except for menstrual period). 10 women will be a control group and will use a placebo cream. The study will be randomized and double blind. Participants will be examined before starting the treatment, at the end of the treatment and 3 months after completion the treatment. A special detailed questionnaire has been prepared in three languages and will be used to compare dyspareunia and associate variables between the groups. The Q-tip tests will be performed and findings will be drawn in each examination. Differences between the groups will be examined, and uni- and multi-variate analysis will be performed.

Conditions

• Vulvar Diseases
• Vulvar Pain
• Vestibulitis
• Vestibulodynia
• Vulvodynia

Interventions

Type	Name	Description
DRUG	Nifedipine cream topical application

Timeline

• Start date: 2006-04-01
• Primary completion: 2007-10-01
• Completion: 2008-05-01
• First posted: 2007-07-04
• Last updated: 2008-05-08

Locations

2 sites across 1 country: Israel