OB/GYN & Women's Health
PHASE2
● Phase II
Phase 2 trial tests different pain treatments for women with vestibulodynia
ClinicalTrials.gov
Published March 30, 2026
Duke University
Researchers conducted a Phase 2 clinical trial to find better ways to treat vestibulodynia (VBD), a condition that causes chronic pain in the vulvar vestibule. The study involved 209 women with two different subtypes of VBD. One type involves pain only in the vulvar area, while the other involves pain there and in other body areas like the jaw, muscles, or gut.
The trial tested three treatment approaches against placebos (inactive treatments). One was a cream containing lidocaine and estradiol applied to the painful area. Another was an oral medication called nortriptyline, which works on the central nervous system. The third was a combination of both the cream and the pill. The main goal was to see which treatment best reduced pain during a specific test and improved patients' overall sense of physical health.
This study is still in its early Phase 2 stage, which means it is designed to gather initial information on whether these treatments might be helpful. No results from the trial are available in the provided information, so we do not yet know if any of the treatments worked better than the placebo. The researchers also aimed to find biological markers in the blood that might predict who would respond best to which treatment, but those findings are not reported here either.
Readers should understand that this is a research step, not a proven new therapy. The outcomes of this trial will be important for designing larger, more definitive studies in the future. If positive, the findings could eventually help doctors and patients make more informed choices about managing this complex pain condition.
View Original Abstract ↓
Status: COMPLETED | Phase: PHASE2
Condition(s): Vestibulodynia, Temporomandibular Disorder, Fibromyalgia Syndrome, Irritable Bowel Syndrome, Migraines
Intervention(s): 5% lidocaine/5 mg/ml 0.02% estradiol compound cream (DRUG), Nortriptyline (DRUG), Placebo cream (DRUG), Placebo pill (DRUG)
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.
Detailed: Vestibulodynia (VBD) is a chronic pelvic pain condition that affects 1 in 6 reproductive aged women, yet remains ineffectively treated by standard trial-and-error approaches. The investigators have identified two distinct VBD subtypes that may benefit from different types of treatment: 1) VBD peripheral (VBD-p) subtype characterized by localized pain specific to the vulvar vestibule, and 2) VBD central (VBD-c) subtype characterized by pain at both vaginal and remote body regions. Preliminary data further demonstrate that VBD-p and VBD-c subtypes differ with respect to patient reported outcomes (e.g., physical and mental health), production of cytokines (intracellular proteins that regulate the activity of pain nerves and inflammatory processes), and expression of microRNAs (small non-codin
Primary Outcome(s): Pain Score During the Tampon Test; Change in Self-reported Pain Via the Short Form- McGill Pain Questionnaire (SF-MPQ); Self-reported Physical Health Via SF-12 Health Survey (SF12v2)
Enrollment: 209 (ACTUAL)
Lead Sponsor: Duke University
Start: 2019-11-04 | Primary Completion: 2024-03-13
Results posted: 2026-03-19
