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

Vulvodynia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00496184
• Other study ID #: 20050989
• Status: Completed
• Phase: Phase 3
• First received: July 2, 2007
• Last updated: May 2, 2008
• Start date: April 2006
• Est. completion date: May 2008

Study information

• Verified date: May 2008
• Source: Western Galilee Hospital-Nahariya
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2008
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Vestibulitis
• Vestibulodynia
• Vulvar Diseases
• Vulvar Pain
• Vulvar Vestibulitis
• Vulvodynia

Intervention

Drug:
• Nifedipine cream topical application

Locations

Country	Name	City	State
Israel	Colposcopy Clinic, Obstetrics and Gynecology Department, Western galilee Hospital	Nahariya
Israel	Department of Obstetrics and Gynecology	Nahariya

Sponsors (1)

Lead Sponsor	Collaborator
Western Galilee Hospital-Nahariya

Country where clinical trial is conducted

Israel, 

References & Publications (3)

Bornstein J, Zarfati D, Goldik Z, Abramovici H. Vulvar vestibulitis: physical or psychosexual problem? Obstet Gynecol. 1999 May;93(5 Pt 2):876-80. Review. — View Citation

Nelson R. Non surgical therapy for anal fissure. Cochrane Database Syst Rev. 2003;(4):CD003431. Review. Update in: Cochrane Database Syst Rev. 2006;(4):CD003431. — View Citation

Walsh KE, Berman JR, Berman LA, Vierregger K. Safety and efficacy of topical nitroglycerin for treatment of vulvar pain in women with vulvodynia: a pilot study. J Gend Specif Med. 2002 Jul-Aug;5(4):21-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.