Vulvodynia Clinical Trial
Official title:
Topical Application of Nifedipine Cream for the Treatment of Vulvar Vestibulitis Syndrome
To evaluate the use of topical application of Nifedipine cream for the treatment of Provoked localized Vulvodynia (vestibulitis, vestibulodynia).
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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