Efficacy Study of Topical Application of Nifedipine Cream to Treat Vulvar Vestibulitis
To evaluate the use of topical application of Nifedipine cream for the treatment of Provoked localized Vulvodynia (vestibulitis, vestibulodynia).
Drug: Nifedipine cream topical application
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Topical Application of Nifedipine Cream for the Treatment of Vulvar Vestibulitis Syndrome|
- Complete resolution of vestibulitis. [ Time Frame: Participants will be examined before starting the treatment, at the end of the treatment and 3 months after completion the treatment, using the questionnaire and the Q-tip applicator for detection of vestibular sensitivity. ]
- Safety of the Nifedipine treatment. [ Time Frame: Participants will be examined before starting the treatment, at the end of the treatment and 3 months after completion the treatment, using the questionnaire. ]
|Study Start Date:||April 2006|
|Study Completion Date:||May 2008|
|Primary Completion Date:||October 2007 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00496184
|Department of Obstetrics and Gynecology|
|Colposcopy Clinic, Obstetrics and Gynecology Department, Western galilee Hospital|
|Principal Investigator:||Jacob Bornstein, MD||Western Galilee Hospital, Nahariya, Israel|
|Principal Investigator:||Doron Zarfati, MD||Western Galilee Hospital, Nahariya, Israel|