Completed

Search for Genetic Basis of Vulvodynia

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What is being collected

Data Collection

Collected at a single point in time - Cross-sectional
Who is being recruted

Urogenital Diseases+4

+ Genital Diseases

+ Female Urogenital Diseases and Pregnancy Complications

From 18 to 70 Years
+4 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Case-Control

Comparing exposures between individuals with and without disease in order to identify potential risk factors.
Observational
Study Start: November 2008
See protocol details

Summary

Principal SponsorWestern Galilee Hospital-Nahariya
Last updated: August 14, 2012
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2008

Actual date on which the first participant was enrolled.

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: HSPE gene: Four polymorphic SNPs: rs4693608, rs11099592, rs6856901 and rs4364254 that were found to be informative in the Ashkenazi Jewish population TRPV1 gene: Two polymorphic SNPs: rs222747 and rs8065080. 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.

NCT01664962
Principal SponsorWestern Galilee Hospital-Nahariya
Last updated: August 14, 2012
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

168 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Case-Control

These studies compare people who have a disease (cases) with those who don't (controls). The goal is to look back at previous exposures or risk factors to identify what might have contributed to the disease.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, FemaleVulvar DiseasesFemale Urogenital DiseasesVulvodynia

Criteria

4 inclusion criteria required to participate
classified with the primary type of the syndrome according to an interview
diagnosed by a gynecological examination with LPV
diagnosed with a severe degree of the syndrome according to Marinoff [48]
with both parents of Ashkenazi origin

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Western Galilee Hospital

Nahariya, IsraelOpen Western Galilee Hospital in Google Maps
CompletedOne Study Center