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Search for Genetic Basis of Vulvodynia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01664962
First Posted: August 14, 2012
Last Update Posted: August 14, 2012
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 (Responsible Party):
Prof. Jacob Bornstein, Western Galilee Hospital-Nahariya
  Purpose
The purpose of this study is to investigate the possibility of an association between Localized Provoked Vulvodynia (LPV) that is both severe and primary and polymorphic markers/single nucleotide polymorphisms (SNPs) in and around the genes encoding heparanase (HSPE-1), Vanilloid Receptor VR1 (TRPV1), and Nerve Growth Factor (NGF).

Condition
Vulvodynia

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional

Further study details as provided by Prof. Jacob Bornstein, Western Galilee Hospital-Nahariya:

Primary Outcome Measures:
  • Genetic association of Vulvodynia [ Time Frame: four years ]
    the possibility of an association between Localized Provoked Vulvodynia (LPV) that is both severe and primary and polymorphic markers/single nucleotide polymorphisms (SNPs) in and around the genes encoding heparanase (HSPE-1), Vanilloid Receptor VR1 (TRPV1), and Nerve Growth Factor (NGF).


Enrollment: 168
Study Start Date: November 2008
Study Completion Date: March 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients
Women with severe Vulvodynia
Healthy controls
Women without vulvodynia

Detailed Description:

The short-term goal proposed for the current study was to investigate the possibility of an association between Localized Provoked Vulvodynia (LPV) that is both severe and primary and polymorphic markers/single nucleotide polymorphisms (SNPs) in and around the genes encoding heparanase (HSPE-1), Vanilloid Receptor VR1 (TRPV1), and Nerve Growth Factor (NGF).

Eight polymorphic SNPs in the three different genes suspected to be involved in LPV has been examined as follow:

  1. HSPE gene: Four polymorphic SNPs: rs4693608, rs11099592, rs6856901 and rs4364254 that were found to be informative in the Ashkenazi Jewish population
  2. TRPV1 gene: Two polymorphic SNPs: rs222747 and rs8065080.
  3. NGF gene: A novel T to C SNP in the promoter region at position -198 (rs11102930) and rs6330 which was found to be associated with anxiety-related personality traits and has been suggested to may affect intracellular processing and secretion of NGF.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with Vulvodynia, Normal healthy controls
Criteria

Inclusion Criteria:o meeting Friedrich's criteria [50] for vulva vestibulitis syndrome

  • diagnosed by a gynecological examination with LPV
  • diagnosed with a severe degree of the syndrome according to Marinoff [48]
  • classified with the primary type of the syndrome according to an interview
  • with both parents of Ashkenazi origin.
  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): NCT01664962


Locations
Israel
Western Galilee Hospital
Nahariya, Israel
Sponsors and Collaborators
Western Galilee Hospital-Nahariya
  More Information

Responsible Party: Prof. Jacob Bornstein, Principal Investigator, Western Galilee Hospital-Nahariya
ClinicalTrials.gov Identifier: NCT01664962     History of Changes
Other Study ID Numbers: 920080002
First Submitted: August 9, 2012
First Posted: August 14, 2012
Last Update Posted: August 14, 2012
Last Verified: August 2012

Additional relevant MeSH terms:
Vulvodynia
Vulvar Diseases
Genital Diseases, Female