Vulvodynia Clinical Trial
Official title:
Activation of the Sphingosine-1-phosphate (S1P) to S1P1 Receptor Subtype (S1PR1) Axis in Patients With Vulvodynia: Identification of Potential Relevant Biomarkers
NCT number | NCT02981433 |
Other study ID # | 27036 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 13, 2019 |
Est. completion date | June 10, 2020 |
Verified date | August 2020 |
Source | St. Louis University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 2 |
Est. completion date | June 10, 2020 |
Est. primary completion date | June 10, 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - 18-70 years of age - Vulvar pain of at least 3 months' duration - Localized (e.g. vestibulodynia, clitorodynia) or Generalized or Mixed - Provoked or Spontaneous or Mixed Onset - Temporal pattern Exclusion Criteria: - <18 or >70 years of age - pregnant - Not able to provide consent - Patients with active vulvar dystrophies. |
Country | Name | City | State |
---|---|---|---|
United States | 1031 Bellevue office suite 200 | Saint Louis | Missouri |
United States | St. Lukes Doctors South Office building | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
St. Louis University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | S1PR1 elevation | S1PR1 is elevated in the peripheral blood leukocytes (PBLs) of patients with vulvodyna-related pain. | up to one year |
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