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Trial record 3 of 30031 for:    Immunologic Factors

Women's Health Study: Immunological Factors and Risk of Vulvodynia

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ClinicalTrials.gov Identifier: NCT02404961
Recruitment Status : Completed
First Posted : April 1, 2015
Last Update Posted : April 1, 2015
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Brief Summary:
The investigators plan to study the etiology of vulvodynia, a condition characterized by chronic vulvar discomfort, most often described as burning pain, occurring in the absence of relevant visible findings or a specific, clinically identifiable, neurologic disorder. Our hypothesis is that vulvodynia is the result of an altered immuno-inflammatory response mechanism that occurs as a consequence of reproductive, gynecologic, environmental, or psychological exposures, with abnormal vaginal microflora and genetic polymorphisms as potential modifiers of the effects of interest. Therefore, the investigators propose to collect information about reproductive, gynecological and environmental exposures, psychological trauma and psychiatric morbidity, and biological markers of immuno-inflammation and nerve fiber proliferation.

Condition or disease Intervention/treatment
Vulvodynia Other: Vulvodynia

Detailed Description:

Women aged 18-40 years who were seen for any reason within a 2-year period at one of the Twin Cities metro-area's Fairview Health Services outpatient clinics will be send a confidential self-administered questionnaire, and given the option to return it by mail, or complete it via phone or via a secure online server. This questionnaire will serve to determine any history of unexplained vulvar pain. Those with a history of past or current vulvar pain likely to represent vulvodynia, will be asked to come to one of four study clinic locations to confirm the diagnosis of vulvodynia. If confirmed, they will be asked to provide venous blood and vulvovaginal specimens. In addition, they will be asked to complete a medical history and psychosocial survey, along with an interviewer-administered Structured Clinical Interview for the Diagnostic and Statistical Manual-IV (SCID-IV). A random sample of women with no history of vulvar pain will be asked to serve as controls. Those confirmed as controls will also be asked to provide the same biological specimens and complete the same questionnaires/interview.

The long-term objective of this research is to provide etiological information that may prove critical to the treatment and prevention of vulvodynia, an under-recognized and extremely debilitating condition that we and others have shown may affect up to 10% of the adult female population.


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Study Type : Observational
Actual Enrollment : 30675 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Immunological Factors and Risk of Vulvodynia
Study Start Date : September 2009
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Group/Cohort Intervention/treatment
Control (no vulvodynia)
Clinically-confirmed as a woman with no history of vulvodynia.
Other: Vulvodynia
Comparison of reproductive, gynecological and environmental exposures, psychological trauma and psychiatric morbidity, and biological markers of immuno-inflammation and nerve fiber proliferation between cases and controls to determine potential etiology of vulvodynia.

Vulvodynia Case
Clinically-confirmed as a woman with vulvodynia.
Other: Vulvodynia
Comparison of reproductive, gynecological and environmental exposures, psychological trauma and psychiatric morbidity, and biological markers of immuno-inflammation and nerve fiber proliferation between cases and controls to determine potential etiology of vulvodynia.




Primary Outcome Measures :
  1. Reproductive, gynecological and environmental exposures and their association with vulvodynia & immuno-inflammatory response [ Time Frame: Baseline ]
    Determine whether reproductive, gynecological and environmental exposures influence the odds of vulvodynia, and whether the effect is associated with immuno-inflammatory response

  2. Past psychological trauma and psychiatric morbidity and their association with vulvodynia & immuno-inflammatory response [ Time Frame: 6 month post baseline visit ]
    Determine whether psychological trauma and psychiatric morbidity influence the odds of vulvodynia and whether the effect is associated with immuno-inflammatory response

  3. immuno-inflammation and nerve fiber proliferation and vulvodynia. [ Time Frame: Baseline ]
    Determine whether markers of immuno-inflammation and nerve fiber proliferation are directly associated with the odds of vulvodynia, and, whether genetic and microbiological markers modify associations, as well as associations evaluated in aims 1 and 2 above.


Biospecimen Retention:   Samples With DNA
Venous Blood and Vulvar punch biopsy


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women aged 18-40 years who were seen for any reason within a 2-year period at one of the metro-area's Fairview Health Services outpatient clinics
Criteria

Inclusion Criteria:

  • Clinically confirmed vulvodynia
  • Women with no history of vulvar discomfort and clinically confirmed as acceptably control.

Exclusion Criteria:

  • Women with vulvar pain attributed to a known cause.
  • Women with any active gynecological yeast, bacterial, or viral infection.

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): NCT02404961


Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
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Principal Investigator: Bernard Harlow, PhD University of Minnesota - Clinical and Translational Science Institute

Publications of Results:
Other Publications:
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Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT02404961     History of Changes
Other Study ID Numbers: 5R01HD058608 ( U.S. NIH Grant/Contract )
First Posted: April 1, 2015    Key Record Dates
Last Update Posted: April 1, 2015
Last Verified: March 2015
Additional relevant MeSH terms:
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Vulvodynia
Vulvar Diseases
Genital Diseases, Female
Immunologic Factors
Physiological Effects of Drugs