Status:
COMPLETED
Vestibulodynia: Understanding Pathophysiology and Determining Appropriate Treatments
Lead Sponsor:
Duke University
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Vestibulodynia
Temporomandibular Disorder
Eligibility:
FEMALE
18-50 years
Phase:
PHASE2
Brief 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 investigat...
Detailed Description
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 id...
Eligibility Criteria
Inclusion
- 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
- 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.
- Active incarceration
- Cancer within the past year.
- Chemotherapy and/or radiation treatment within the past year.
- Unstable medical condition (e.g., renal impairment, significant hematological disease, cardiovascular disease, hepatic insufficiency, neurological disorder, autoimmune disease, or respiratory illness)
- Clear inflammatory states (e.g., morbid obesity)
- Use of immunosuppressant medications
- History of intolerance to nortriptyline, topical lidocaine, or topical estradiol
- Contraindications to use of nortriptyline: current use, or use within the past 3 months, of MAOIs, SSRIs, SNRIs, NDRIs; recent (within the past year) myocardial infarction, active psychotic or suicidal thoughts, narrow angle closure glaucoma
- Contraindications to the use of lidocaine or local anesthetics
- Contraindications to the use of topical estrogen therapy
- Post-menopausal, defined as no menses for 12 consecutive months or surgical removal of both ovaries. (Hysterectomy is not an exclusion)
- Have not had Botox of the pelvic floor muscles in the last 12 months, or pelvic nerve blocks in the last three months.
- Are not currently enrolled or planning to enroll in another clinical trial during the course of this trial.
- Are not currently receiving pelvic physical therapy
Exclusion
Key Trial Info
Start Date :
November 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2024
Estimated Enrollment :
223 Patients enrolled
Trial Details
Trial ID
NCT03844412
Start Date
November 4 2019
End Date
May 30 2024
Last Update
June 7 2024
Active Locations (2)
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1
University of California, Los Angeles
Los Angeles, California, United States, 90095
2
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27278