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Vestibulodynia: Understanding Pathophysiology and Determining Appropriate Treatments (Vestibulod - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn what treatments work best for women who have Vestibulodynia (pain at the vaginal opening).
What is the Condition Being Studied?
Vestibulodynia (vaginal pain study)

Who Can Participate in the Study?

-Women 18-50
-Diagnosed with vestibulodynia or think you may have vestibulodynia (vaginal pain)
-Not currently using vaginal cream with lidocaine or estradiol

Age Group
Adults

What is Involved?

If you choose to join this study you will:
-Be randomized (like drawing numbers out of a hat) to 1 of 4 groups:
--Group 1 will get medicated vaginal cream and a pill (Nortriptyline)
--Group 2 will get medicated vaginal cream and a placebo pill (a harmless pill that does nothing)
--Group 3 will get vaginal placebo cream (a cream that does nothing) and a pill (Nortriptyline)
--Group 4 will get vaginal placebo cream and a placebo pill

Everyone will be asked to:
-Have blood draws
-Have a vaginal exam to collect samples
-Complete questionnaires
-Complete 4 clinic visits at UNC Hospitals in Hillsborough over 6 months

Study Details

Full Title
Vestibulodynia: Understanding Pathophysiology and Determining Appropriate Treatments (Vestibulodynia: UPDATe)
Principal Investigator
AndreaNeely
Protocol Number
IRB: PRO00100678
NCT: NCT03844412
Phase
Phase II
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698