Vestibulodynia: Understanding Pathophysiology and Determining Appropriate Treatments
United States209 participantsStarted 2019-11-04
Plain-language 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.
Who can participate
Age range18 Years – 50 Years
SexFEMALE
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Inclusion criteria
✓. Female
✓. Age 18-50 years
✓. English-literate
✓. Willingness to provide informed consent
✓. Meeting criteria for diagnosis of VBD based on:
✓. self-report of 3 continuous months of insertional (entryway) dyspareunia, and/or pain to touch/tampon insertion
✓. pain score of ≥ 3 on the tampon insertion test
Exclusion criteria
✕. Use of daily topical lidocaine, or estradiol, or lidocaine/estradiol to the vulvar vestibule within the past three months
✕. Use of nortriptyline or other TCA medications within the past three months
✕. Use of pregabalin or gabapentin within the past three months
✕
What they're measuring
1
Pain Score During the Tampon Test
Timeframe: Baseline, 16 weeks
2
Change in Self-reported Pain Via the Short Form- McGill Pain Questionnaire (SF-MPQ)
Timeframe: Baseline, 16 weeks
3
Self-reported Physical Health Via SF-12 Health Survey (SF12v2)
Timeframe: Prior to randomization
4
Self-reported Mental Health Via SF-12 Health Survey (SF12v2)
Timeframe: Prior to randomization
5
Sexual Health Via Patient-Reported Outcomes Measurement Information System (PROMIS)
. Presence of active dermatologic vulvar disease or vaginal infection
✕. Untreated atrophic vaginitis (participants may undergo treatment and re-evaluation for enrollment if the condition is resolved)
✕. Previous vestibulectomy
✕. Pregnant or planning on becoming pregnant during the study period. Within the first six months of the postpartum period. Currently breastfeeding/lactating, or within three months of discontinuing breastfeeding/lactation.