223
Participants
Start Date
November 4, 2019
Primary Completion Date
March 13, 2024
Study Completion Date
May 30, 2024
5% lidocaine/5 mg/ml 0.02% estradiol compound cream
Lidocaine/estradiol cream targets peripheral nerves and tissues affected in VBD. Participants will be provided with a diagram and written instructions, detailing how to apply the cream to the vaginal vestibule daily for weeks 1-16. Treatment with lidocaine/estradiol or placebo cream will be terminated at week 16 (end of month 4).
Nortriptyline
Nortriptyline is a centrally-acting tricyclic antidepressant that is FDA-approved for treatment of neuropathic pain. Dosing will begin with one 10 mg pill nightly for week 1, then two 10 mg pills nightly for week 2, three 10 mg pills nightly for week 3, four 10 mg pills nightly for week 4, and five for weeks 5 -16. Treatment with nortriptyline or placebo pill will be tapered off over weeks 16-18, decreasing the dose by 10 mg every 4 days. Participants will be provided with a list of drugs to avoid that are known to interact with nortriptyline.
Placebo cream
The comparison treatment will be an identical-appearing placebo Moisturel™ cream
Placebo pill
The comparison treatment will be an identical-appearing placebo pill
University of North Carolina at Chapel Hill, Chapel Hill
University of California, Los Angeles, Los Angeles
Lead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Duke University
OTHER