Efficacy Study of Topical Application of Nifedipine Cream to Treat Vulvar Vestibulitis
Topical Application of Nifedipine Cream for the Treatment of Vulvar Vestibulitis Syndrome
1 other identifier
interventional
30
1 country
2
Brief Summary
To evaluate the use of topical application of Nifedipine cream for the treatment of Provoked localized Vulvodynia (vestibulitis, vestibulodynia).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Apr 2006
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2006
CompletedFirst Submitted
Initial submission to the registry
July 2, 2007
CompletedFirst Posted
Study publicly available on registry
July 4, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2008
CompletedMay 8, 2008
May 1, 2008
1.5 years
July 2, 2007
May 2, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Women who have undergone vestibulectomy.
- Active vaginal or pelvic infection.
- A medical disease uch as Diabetes, immune suppression.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Colposcopy Clinic, Obstetrics and Gynecology Department, Western galilee Hospital
Nahariya, Israel
Department of Obstetrics and Gynecology
Nahariya, Israel
Related Publications (3)
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.
PMID: 12192883BACKGROUNDNelson R. Non surgical therapy for anal fissure. Cochrane Database Syst Rev. 2003;(4):CD003431. doi: 10.1002/14651858.CD003431.
PMID: 14583976BACKGROUNDBornstein J, Zarfati D, Goldik Z, Abramovici H. Vulvar vestibulitis: physical or psychosexual problem? Obstet Gynecol. 1999 May;93(5 Pt 2):876-80. doi: 10.1016/s0029-7844(98)00535-3.
PMID: 10912437BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jacob Bornstein, MD
Western Galilee Hospital, Nahariya, Israel
- PRINCIPAL INVESTIGATOR
Doron Zarfati, MD
Western Galilee Hospital, Nahariya, Israel
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
July 2, 2007
First Posted
July 4, 2007
Study Start
April 1, 2006
Primary Completion
October 1, 2007
Study Completion
May 1, 2008
Last Updated
May 8, 2008
Record last verified: 2008-05