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

Sponsor

Western Galilee Hospital-Nahariya (Other)

Overall Status

Completed

CT.gov ID

NCT00496184

Collaborator

(none)

Enrollment

Locations

Duration (Months)

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Vulvar Diseases Vulvar Pain Vestibulitis Vestibulodynia Vulvodynia	Drug: Nifedipine cream topical application	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2006

Actual Primary Completion Date :

Oct 1, 2007

Actual Study Completion Date :

May 1, 2008

Outcome Measures

Primary Outcome Measures

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

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.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Colposcopy Clinic, Obstetrics and Gynecology Department, Western galilee Hospital	Nahariya		Israel
2	Department of Obstetrics and Gynecology	Nahariya		Israel

Sponsors and Collaborators

Western Galilee Hospital-Nahariya

Investigators

Principal Investigator: Jacob Bornstein, MD, Western Galilee Hospital, Nahariya, Israel
Principal Investigator: Doron Zarfati, MD, Western Galilee Hospital, Nahariya, Israel