Efficacy Study of Topical Application of Nifedipine Cream to Treat Vulvar Vestibulitis - Full Text View

Sponsor:	Western Galilee Hospital-Nahariya
Information provided by:	Western Galilee Hospital-Nahariya
ClinicalTrials.gov Identifier:	NCT00496184

Purpose

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

Condition	Intervention	Phase
Vulvar Diseases Vulvar Pain Vestibulitis Vestibulodynia Vulvodynia	Drug: Nifedipine cream topical application	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Topical Application of Nifedipine Cream for the Treatment of Vulvar Vestibulitis Syndrome

Resource links provided by NLM:

Drug Information available for: Nifedipine

U.S. FDA Resources

Further study details as provided by Western Galilee Hospital-Nahariya:

Primary Outcome 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 Outcome 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. ]

Estimated Enrollment:	30
Study Start Date:	April 2006
Study Completion Date:	May 2008
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00496184

Locations

Israel
Department of Obstetrics and Gynecology
Nahariya, Israel
Colposcopy Clinic, Obstetrics and Gynecology Department, Western galilee Hospital
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

More Information

Publications:

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.

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.

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.

Study ID Numbers:	20050989
Study First Received:	July 2, 2007
Last Updated:	May 2, 2008
ClinicalTrials.gov Identifier:	NCT00496184 History of Changes
Health Authority:	Israel: Ministry of Health

Keywords provided by Western Galilee Hospital-Nahariya:

Nifedipine treatment
Vestibulitis
Placebo

Additional relevant MeSH terms:

Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Calcium Channel Blockers
Reproductive Control Agents
Cardiovascular Agents
Nifedipine
Pharmacologic Actions

Genital Diseases, Female
Membrane Transport Modulators
Tocolytic Agents
Vulvar Vestibulitis
Therapeutic Uses
Vulvitis
Vulvar Diseases

ClinicalTrials.gov processed this record on February 08, 2010