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

Phase 3

Completed

• Conditions: Vulvar Diseases; Vulvar Pain; Vestibulitis; Vestibulodynia; Vulvodynia

• Registration Number: NCT00496184
• Lead Sponsor: Western Galilee Hospital-Nahariya

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2006-04
• Study First Submitted: 2007-07-02
• Study First Submitted QC: 2007-07-03
• Study First Posted: 2007-07-04
• Primary Completion: 2007-10
• Status Verified: 2008-05
• Study Completion: 2008-05
• Last Update Submitted: 2008-05-02
• Last Update Posted: 2008-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (2)

Colposcopy Clinic, Obstetrics and Gynecology Department, Western galilee Hospital; 🇮🇱 Nahariya, Israel

Department of Obstetrics and Gynecology; 🇮🇱 Nahariya, Israel