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

Primary Purpose

Vulvar Diseases, Vulvar Pain, Vestibulitis

Status
Completed
Phase
Phase 3
Locations
Israel
Study Type
Interventional
Intervention
Nifedipine cream topical application
Sponsored by
Western Galilee Hospital-Nahariya
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vulvar Diseases focused on measuring Nifedipine treatment, Vestibulitis, Placebo

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Colposcopy Clinic, Obstetrics and Gynecology Department, Western galilee Hospital
  • Department of Obstetrics and Gynecology

Outcomes

Primary Outcome Measures

Complete resolution of vestibulitis.

Secondary Outcome Measures

Safety of the Nifedipine treatment.

Full Information

First Posted
July 2, 2007
Last Updated
May 2, 2008
Sponsor
Western Galilee Hospital-Nahariya
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1. Study Identification

Unique Protocol Identification Number
NCT00496184
Brief Title
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

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Western Galilee Hospital-Nahariya

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vulvar Diseases, Vulvar Pain, Vestibulitis, Vestibulodynia, Vulvodynia
Keywords
Nifedipine treatment, Vestibulitis, Placebo

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Nifedipine cream topical application
Primary Outcome Measure Information:
Title
Complete resolution of vestibulitis.
Time Frame
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 Outcome Measure Information:
Title
Safety of the Nifedipine treatment.
Time Frame
Participants will be examined before starting the treatment, at the end of the treatment and 3 months after completion the treatment, using the questionnaire.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Women who have undergone vestibulectomy. Active vaginal or pelvic infection. A medical disease uch as Diabetes, immune suppression.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacob Bornstein, MD
Organizational Affiliation
Western Galilee Hospital, Nahariya, Israel
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Doron Zarfati, MD
Organizational Affiliation
Western Galilee Hospital, Nahariya, Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Colposcopy Clinic, Obstetrics and Gynecology Department, Western galilee Hospital
City
Nahariya
Country
Israel
Facility Name
Department of Obstetrics and Gynecology
City
Nahariya
Country
Israel

12. IPD Sharing Statement

Citations:
PubMed Identifier
12192883
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.
Results Reference
background
PubMed Identifier
14583976
Citation
Nelson R. Non surgical therapy for anal fissure. Cochrane Database Syst Rev. 2003;(4):CD003431. doi: 10.1002/14651858.CD003431.
Results Reference
background
PubMed Identifier
10912437
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.
Results Reference
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Learn more about this trial

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

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