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

May 2, 2008 updated by: Western Galilee Hospital-Nahariya

Topical Application of Nifedipine Cream for the Treatment of Vulvar Vestibulitis Syndrome

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

Study Overview

Status

Completed

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
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 Measures

Outcome Measure
Time Frame
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.
Participants will be examined before starting the treatment, at the end of the treatment and 3 months after completion the treatment, using the questionnaire.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Western Galilee Hospital-Nahariya

Investigators

  • Principal Investigator: Jacob Bornstein, MD, Western Galilee Hospital, Nahariya, Israel
  • Principal Investigator: Doron Zarfati, MD, Western Galilee Hospital, Nahariya, Israel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (ACTUAL)

October 1, 2007

Study Completion (ACTUAL)

May 1, 2008

Study Registration Dates

First Submitted

July 2, 2007

First Submitted That Met QC Criteria

July 3, 2007

First Posted (ESTIMATE)

July 4, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

May 8, 2008

Last Update Submitted That Met QC Criteria

May 2, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20050989

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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