Clinical trial NCT00496184: Efficacy Study of Topical Application of Nifedipine Cream to Treat Vulvar Vestibulitis
Official title: Topical Application of Nifedipine Cream for the Treatment of Vulvar Vestibulitis Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vulvar Diseases
Vulvar Pain
Vestibulitis
Vestibulodynia
Vulvodynia
Keywords: Nifedipine treatment
Vestibulitis
Placebo
Lead sponsor: Western Galilee Hospital-Nahariya
Sponsor class: OTHER_GOV
First posted: 2007-07-04
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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.

Primary outcomes:
measure: Complete resolution of vestibulitis.
timeFrame: 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:
measure: Safety of the Nifedipine treatment.
timeFrame: Participants will be examined before starting the treatment, at the end of the treatment and 3 months after completion the treatment, using the questionnaire.
Other outcomes:
Locations:
city: Nahariya
country: Israel
facility: Colposcopy Clinic, Obstetrics and Gynecology Department, Western galilee Hospital
city: Nahariya
country: Israel
facility: Department of Obstetrics and Gynecology
Study officials:
affiliation: Western Galilee Hospital, Nahariya, Israel
name: Jacob Bornstein, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Western Galilee Hospital, Nahariya, Israel
name: Doron Zarfati, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Nelson R. Non surgical therapy for anal fissure. Cochrane Database Syst Rev. 2003;(4):CD003431. doi: 10.1002/14651858.CD003431.
citation: 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.