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

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

Detailed Description
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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.

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

Conditions
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Vulvar Diseases, Vulvar Pain, Vestibulitis, Vestibulodynia, Vulvodynia

Intervention / Treatment
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* Drug: Nifedipine cream topical application


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women diagnosed with vestibulitis according to Friedrich's criteria: Severe pain with vestibular touch or attempted vaginal entry. A positive Q-tip test: pain produced by touching the vestibule with a cotton tipped applicator. Physical findings limited to varying degree of vestibular erythema. Non-pregnant women aged 18-45. Women use effective contraception and are not interested in becoming pregnant during the study period. No known Nifedipine allergy. No medical diseases. Exclusion Criteria: Women who have undergone vestibulectomy. Active vaginal or pelvic infection. A medical disease uch as Diabetes, immune suppression.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Nifedipine cream topical application|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete resolution of vestibulitis. |  | 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of the Nifedipine treatment. |  | Participants will be examined before starting the treatment, at the end of the treatment and 3 months after completion the treatment, using the questionnaire. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nifedipine treatment, Vestibulitis, Placebo