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

Information source: Western Galilee Hospital-Nahariya
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Vulvar Diseases; Vulvar Pain; Vestibulitis; Vestibulodynia; Vulvodynia

Intervention: Nifedipine cream topical application (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Western Galilee Hospital-Nahariya

Official(s) and/or principal investigator(s):
Jacob Bornstein, MD, Principal Investigator, Affiliation: Western Galilee Hospital, Nahariya, Israel
Doron Zarfati, MD, Principal Investigator, Affiliation: Western Galilee Hospital, Nahariya, Israel

Summary

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

Clinical Details

Official title: Topical Application of Nifedipine Cream for the Treatment of Vulvar Vestibulitis Syndrome

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

Primary outcome: Complete resolution of vestibulitis.

Secondary outcome: Safety of the Nifedipine treatment.

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

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Female.

Criteria:

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.

Locations and Contacts

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

Department of Obstetrics and Gynecology, Nahariya, Israel

Additional Information

Related 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.

Starting date: April 2006
Last updated: May 2, 2008

Page last updated: August 23, 2015

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