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).
Who Can Participate?
Eligibility
-Women 18-50
-Diagnosed with vestibulodynia or think you may have vestibulodynia (vaginal pain)
-Not currently using vaginal cream with lidocaine or estradiol
-Diagnosed with vestibulodynia or think you may have vestibulodynia (vaginal pain)
-Not currently using vaginal cream with lidocaine or estradiol
Age Range
18-50
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
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
-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
Locations
Other
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
Vestibulodynia: Understanding Pathophysiology and Determining Appropriate Treatments (Vestibulodynia: UPDATe)
Principal Investigator
Andrea
Neely
Protocol Number
PRO00100678
NCT ID
NCT03844412
Phase
II
Enrollment Status
OPEN TO ACCRUAL