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

NCT ID: NCT00496184

Last Updated: 2008-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2008-05-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Vulvar Diseases Vulvar Pain Vestibulitis Vestibulodynia Vulvodynia

Keywords

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Nifedipine treatment Vestibulitis Placebo

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Nifedipine cream topical application

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Western Galilee Hospital-Nahariya

OTHER_GOV

Sponsor Role lead

Principal Investigators

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Jacob Bornstein, MD

Role: PRINCIPAL_INVESTIGATOR

Western Galilee Hospital, Nahariya, Israel

Doron Zarfati, MD

Role: PRINCIPAL_INVESTIGATOR

Western Galilee Hospital, Nahariya, Israel

Locations

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Colposcopy Clinic, Obstetrics and Gynecology Department, Western galilee Hospital

Nahariya, , Israel

Site Status

Department of Obstetrics and Gynecology

Nahariya, , Israel

Site Status

Countries

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Israel

References

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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.

Reference Type BACKGROUND
PMID: 12192883 (View on PubMed)

Nelson R. Non surgical therapy for anal fissure. Cochrane Database Syst Rev. 2003;(4):CD003431. doi: 10.1002/14651858.CD003431.

Reference Type BACKGROUND
PMID: 14583976 (View on PubMed)

Bornstein 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.

Reference Type BACKGROUND
PMID: 10912437 (View on PubMed)

Other Identifiers

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20050989

Identifier Type: -

Identifier Source: org_study_id