NCT02404961|Completed
Women's Health Study: Immunological Factors and Risk of Vulvodynia
Immunological Factors and Risk of Vulvodynia
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Immunological Factors and Risk of Vulvodynia
Sponsor study identifier
Secondary identifiers
NIH
observational
30,675
0 countries
N/A
Study Start
September 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2014
Actual (reported)Study Completion
December 2014
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2014
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2009
Date type not reportedThis date has not been verified as actual or estimated.
December 2014
Actual (reported)December 2014
Actual (reported)March 20, 2015
Actual (reported)April 1, 2015
Actual (reported)Reproductive, gynecological and environmental exposures and their association with vulvodynia & immuno-inflammatory response
Determine whether reproductive, gynecological and environmental exposures influence the odds of vulvodynia, and whether the effect is associated with immuno-inflammatory response
Baseline
Past psychological trauma and psychiatric morbidity and their association with vulvodynia & immuno-inflammatory response
Determine whether psychological trauma and psychiatric morbidity influence the odds of vulvodynia and whether the effect is associated with immuno-inflammatory response
6 month post baseline visit
immuno-inflammation and nerve fiber proliferation and vulvodynia.
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.
Baseline
Clinically-confirmed as a woman with no history of vulvodynia.
Clinically-confirmed as a woman with 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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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
Nguyen RH, Turner RM, Rydell SA, Maclehose RF, Harlow BL. Perceived stereotyping and seeking care for chronic vulvar pain. Pain Med. 2013 Oct;14(10):1461-7. doi: 10.1111/pme.12151. Epub 2013 Jun 6.
Nguyen RH, Turner RM, Sieling J, Williams DA, Hodges JS, Harlow BL. Feasibility of collecting vulvar pain variability and its correlates using prospective collection with smartphones. Pain Res Treat. 2014;2014:659863. doi: 10.1155/2014/659863. Epub 2014 Jun 10.
Venous Blood and Vulvar punch biopsy
Bernard Harlow, PhD
University of Minnesota
30,675 participants (actual enrollment reported by the registry).
First Submitted
March 20, 2015
First Posted
April 1, 2015
Study Start
September 2009
Date type not reportedThis date has not been verified as actual or estimated.
A Randomized Clinical Trial for Women With Vulvodynia
Contact the study team to confirm eligibility.
Harlow BL, Kunitz CG, Nguyen RH, Rydell SA, Turner RM, MacLehose RF. Prevalence of symptoms consistent with a diagnosis of vulvodynia: population-based estimates from 2 geographic regions. Am J Obstet Gynecol. 2014 Jan;210(1):40.e1-8. doi: 10.1016/j.ajog.2013.09.033. Epub 2013 Sep 28.
Nguyen RH, Reese RL, Harlow BL. Differences in pain subtypes between Hispanic and non-Hispanic white women with chronic vulvar pain. J Womens Health (Larchmt). 2015 Feb;24(2):144-50. doi: 10.1089/jwh.2014.4892. Epub 2015 Jan 20.
Primary Completion
December 2014
Actual (reported)Study Completion
December 2014
Actual (reported)Last Updated
November 1, 2019
Record last verified: 2019-10
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Source: ClinicalTrials.gov.
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