Search for Genetic Basis of Vulvodynia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prof. Jacob Bornstein, Western Galilee Hospital-Nahariya
ClinicalTrials.gov Identifier:
NCT01664962
First received: August 9, 2012
Last updated: August 13, 2012
Last verified: August 2012
  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 Western Galilee Hospital-Nahariya:

Primary Outcome Measures:
  • Genetic association of Vulvodynia [ Time Frame: four years ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 70 Years
Genders 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
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: NCT01664962

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

No publications provided

Responsible Party: Prof. Jacob Bornstein, Principal Investigator, Western Galilee Hospital-Nahariya
ClinicalTrials.gov Identifier: NCT01664962     History of Changes
Other Study ID Numbers: 920080002
Study First Received: August 9, 2012
Last Updated: August 13, 2012
Health Authority: Israel: Ministry of Health

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

ClinicalTrials.gov processed this record on July 23, 2014