Efficacy Study of Topical Application of Nifedipine Cream to Treat Vulvar Vestibulitis
Information source: Western Galilee Hospital-Nahariya
Information obtained from ClinicalTrials.gov on June 20, 2008
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: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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
Department of Obstetrics and Gynecology, Nahariya, Israel
Colposcopy Clinic, Obstetrics and Gynecology Department, Western galilee Hospital, 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
Ending date: May 2008
Last updated: May 2, 2008
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