Trial record 11 of 36 for:    vulvodynia

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
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 April 15, 2014