Efficacy Study of Topical Application of Nifedipine Cream to Treat Vulvar Vestibulitis
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|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. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|