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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00496184
First Posted: July 4, 2007
Last Update Posted: May 8, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Western Galilee Hospital-Nahariya
  Purpose
To evaluate the use of topical application of Nifedipine cream for the treatment of Provoked localized Vulvodynia (vestibulitis, vestibulodynia).

Condition Intervention Phase
Vulvar Diseases Vulvar Pain Vestibulitis Vestibulodynia Vulvodynia Drug: Nifedipine cream topical application Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Topical Application of Nifedipine Cream for the Treatment of Vulvar Vestibulitis Syndrome

Resource links provided by NLM:


Further study details as provided by Western Galilee Hospital-Nahariya:

Primary Outcome Measures:
  • 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 Measures:
  • 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. ]

Estimated Enrollment: 30
Study Start Date: April 2006
Study Completion Date: May 2008
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00496184


Locations
Israel
Colposcopy Clinic, Obstetrics and Gynecology Department, Western galilee Hospital
Nahariya, Israel
Department of Obstetrics and Gynecology
Nahariya, Israel
Sponsors and Collaborators
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
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00496184     History of Changes
Other Study ID Numbers: 20050989
First Submitted: July 2, 2007
First Posted: July 4, 2007
Last Update Posted: May 8, 2008
Last Verified: May 2008

Keywords provided by Western Galilee Hospital-Nahariya:
Nifedipine treatment
Vestibulitis
Placebo

Additional relevant MeSH terms:
Vulvodynia
Vulvar Vestibulitis
Vulvar Diseases
Genital Diseases, Female
Vulvitis
Nifedipine
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs