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

Western Galilee Hospital-Nahariya30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Vulvar Diseases Vulvar Pain Vestibulitis Vestibulodynia Vulvodynia

Interventions

Nifedipine cream topical applicationDRUG

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. 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. 2. Non-pregnant women aged 18-45. 3. Women use effective contraception and are not interested in becoming pregnant during the study period. 4. No known Nifedipine allergy. 5. No medical diseases. Exclusion Criteria: 1. Women who have undergone vestibulectomy. 2. Active vaginal or pelvic infection. 3. A medical disease uch as Diabetes, immune suppression.

Locations (2)

Colposcopy Clinic, Obstetrics and Gynecology Department, Western galilee Hospital

Nahariya, Israel

Department of Obstetrics and Gynecology

Nahariya, Israel

Outcomes

Primary Outcomes

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.

Secondary Outcomes

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.

Data from ClinicalTrials.gov

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