Vestibulodynia: Understanding Pathophysiology and Determining Appropriate Treatments
Status:
Recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
Summary
Vestibulodynia (VBD) is a complex chronic vulvar pain condition that impairs the
psychological, physical, and sexual health of 1 in 6 reproductive aged women in the United
States. Here, the investigators plan to conduct a randomized, double-blinded,
placebo-controlled clinical trial to 1) compare the efficacy of peripheral
(lidocaine/estradiol cream), centrally-targeted (nortriptyline), and combined treatments in
alleviating pain and improving patient-reported outcomes and 2) determine cytokine and
microRNA biomarkers that predict treatment response in women with distinct VBD subtypes.
Positive findings from this study will readily translate to improved patient care, permitting
the millions of women with VBD, their partners, and their clinicians to make more informed
decisions about pain management.
Phase:
Phase 2
Details
Lead Sponsor:
Duke University
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)