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

This study has been completed.
Sponsor:
Information provided by:
Western Galilee Hospital-Nahariya
ClinicalTrials.gov Identifier:
NCT00496184
First received: July 2, 2007
Last updated: May 2, 2008
Last verified: May 2008
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: July 2, 2007
Last Updated: May 2, 2008
Health Authority: Israel: Ministry of Health

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

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

ClinicalTrials.gov processed this record on October 23, 2014