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).

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: October 2007

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.

Intervention(s) in this Clinical Trial

• Drug: Nifedipine cream topical application

Primary Measures

• 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 Measures

• 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.
    

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.

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 45 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Western Galilee Hospital-Nahariya

Overall Clinical Trial Officials and Contacts

Jacob Bornstein, MD Principal Investigator Western Galilee Hospital, Nahariya, Israel  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00496184

Study ID Number: 20050989

ClinicalTrials.gov Identifier: NCT00496184

Health Authority: Israel: Ministry of Health