Vestibulodynia: Understanding Pathophysiology and Determining Appropriate Treatments

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.

Conditions

• Vestibulodynia
• Temporomandibular Disorder
• Fibromyalgia Syndrome
• Irritable Bowel Syndrome
• Migraines
• Tension Headache
• Endometriosis
• Interstitial Cystitis
• Back Pain
• Chronic Fatigue Syndrome

Interventions

DRUG

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).

DRUG

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.

DRUG

Placebo cream

The comparison treatment will be an identical-appearing placebo Moisturel™ cream

DRUG

Placebo pill

The comparison treatment will be an identical-appearing placebo pill

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• Duke University

  lead OTHER

Principal Investigators

• Andrea Nackley, PhD · Duke University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-11-04

Primary Completion

2024-03-13

Completion

2024-05-30

FDA Drug

Yes

Countries

• United States

Study Locations