NCT00501774

Brief Summary

Hypothesis: to examine a possible association between localized vulvodynia and H. pylori infection.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2004

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 13, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 16, 2007

Completed
Last Updated

July 16, 2007

Status Verified

July 1, 2007

First QC Date

July 13, 2007

Last Update Submit

July 13, 2007

Conditions

Keywords

Localized vulvodyniaHelicobacter pyloripeptic diseaseomeprazole

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Paraffin blocks of vestibular tissues from patients with Vestibulodynia

You may not qualify if:

  • Patients without vestibulodynia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pathology Laboratory

Haifa, Israel

Location

Related Publications (2)

  • Harlow BL, Stewart EG. A population-based assessment of chronic unexplained vulvar pain: have we underestimated the prevalence of vulvodynia? J Am Med Womens Assoc (1972). 2003 Spring;58(2):82-8.

    PMID: 12744420BACKGROUND
  • Gray SF, Wyatt JI, Rathbone BJ. Simplified techniques for identifying Campylobacter pyloridis. J Clin Pathol. 1986 Nov;39(11):1279. doi: 10.1136/jcp.39.11.1279-a. No abstract available.

    PMID: 2432094BACKGROUND

MeSH Terms

Conditions

VulvodyniaVulvar Vestibulitis

Condition Hierarchy (Ancestors)

Vulvar DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesVulvitis

Study Officials

  • Jacob Bornstein, MD

    westen Galilee Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

July 13, 2007

First Posted

July 16, 2007

Study Start

May 1, 2004

Study Completion

June 1, 2007

Last Updated

July 16, 2007

Record last verified: 2007-07

Locations