Efficacy Study of Topical Application of Nifedipine Cream to Treat Vulvar Vestibulitis
|ClinicalTrials.gov Identifier: NCT00496184|
Recruitment Status : Completed
First Posted : July 4, 2007
Last Update Posted : May 8, 2008
|Condition or disease||Intervention/treatment||Phase|
|Vulvar Diseases Vulvar Pain Vestibulitis Vestibulodynia Vulvodynia||Drug: Nifedipine cream topical application||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Topical Application of Nifedipine Cream for the Treatment of Vulvar Vestibulitis Syndrome|
|Study Start Date :||April 2006|
|Actual Primary Completion Date :||October 2007|
|Actual Study Completion Date :||May 2008|
- 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. ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00496184
|Colposcopy Clinic, Obstetrics and Gynecology Department, Western galilee Hospital|
|Department of Obstetrics and Gynecology|
|Principal Investigator:||Jacob Bornstein, MD||Western Galilee Hospital, Nahariya, Israel|
|Principal Investigator:||Doron Zarfati, MD||Western Galilee Hospital, Nahariya, Israel|