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NCT02981433 · ClinicalTrials.gov registry record

Vulvodynia: Identification of Potential Relevant Biomarkers

A clinical trial, sponsored by St. Louis University.

Completed
Registry status
2
Enrollment target

NCT02981433: Completed study, sponsored by St. Louis University.

NCT02981433 is a clinical trial that has completed, run by St. Louis University. The registered enrollment target is 2 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02981433 has completed, sponsored by St. Louis University.

COMPLETED
Registry status
2 participants
Enrollment target

Study Summary

Vulvodynia is a syndrome of unexplained vulvar pain that is frequently accompanied by physical disabilities, limitation of daily activities (such as sitting and walking), sexual dysfunction and psychologic disability. Originally suggested by McKay, the term "vulvodynia" has also been suggested by the International Society for the Study of Vulvar Disease Task Force to describe any vulvar pain. The incidence and prevalence of vulvodynia have not been well studied. Age distribution for the condition may range from the 20s to the 60s, and it is limited almost exclusively to white women. Obstetric and gynecologic history is usually unremarkable. Risk-taking sexual behavior is rare, and few patients have a history of sexually transmitted diseases. Vulvar pain usually has an acute onset, at times associated with episodes of vaginitis or certain therapeutic procedures of the vulva (cryotherapy or laser therapy). In most cases, vulvodynia becomes a chronic problem lasting months to years. Vulvar pain is frequently described as burning or stinging, or a feeling of rawness or irritation. Most patients consult several physicians before being diagnosed. Many are treated with multiple topical or systemic medications, with minimal relief. In some cases, inappropriate therapy may even make the symptoms worse. Since physical findings are few and cultures and biopsies are frequently negative, patients may be told that the problem is primarily psychologic, thus invalidating their pain and adding to their distress.

Primary Outcome

S1PR1 is elevated in the peripheral blood leukocytes (PBLs) of patients with vulvodyna-related pain.

Trial Details

FieldValue
Enrollment Target 2 participants
Start Date 2019-03-13
Est. Completion 2020-06-10
St. Louis University

107 total trials

What the finished NCT02981433 record still lists

NCT02981433 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 2 participants, a relatively small participant target.

The record links to 0 conditions, and to 0 interventions.

NCT02981433 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02981433 about?

NCT02981433 is a clinical study titled "Vulvodynia: Identification of Potential Relevant Biomarkers". Vulvodynia is a syndrome of unexplained vulvar pain that is frequently accompanied by physical disabilities, limitation of daily activities (such as sitting and walking), sexual dysfunction and psychologic disability. Originally suggested by McKay, the term "vulvodynia" has also been suggested by th...

What is the current status of trial NCT02981433?

This trial is currently completed. The enrollment target is 2 participants. The study started on 2019-03-13. Estimated completion is 2020-06-10.

Who is sponsoring clinical trial NCT02981433?

This trial is sponsored by St. Louis University, which has 107 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT02981433, the US trial registry maintained by the National Library of Medicine. NCT02981433 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.