Vestibulodynia: Understanding Pathophysiology and Determining Appropriate Treatments

Plain-language summary

This study aims to understand the mechanism of vestibulodynia (a chronic vulvar pain condition) and to identify appropriate treatments, comparing a lidocaine/estradiol cream and Nortriptyline pills with their placebos. Women aged 18-50 with at least 3 months of entryway pain were able to take part. It was conducted in Phase 2 and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 2

Status

Completed

Sponsor

Duke University

Intervention

5% lidocaine/5 mg/ml 0.02% estradiol compound cream, Nortriptyline, Placebo cream, Placebo pill

Start date

11/4/2019

Estimated completion

5/30/2024

Countries

United States

Related genes

Locations

• Los Angeles, United States
• Chapel Hill, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria

1. Female
2. Age 18-50 years
3. English-literate
4. Willingness to provide informed consent
5. Meeting criteria for diagnosis of VBD based on:

   1. self-report of 3 continuous months of insertional (entryway) dyspareunia, and/or pain to touch/tampon insertion
   2. pain score of ≥ 3 on the tampon insertion test

Exclusion Criteria

1. Use of daily topical lidocaine, or estradiol, or lidocaine/estradiol to the vulvar vestibule within the past three months
2. Use of nortriptyline or other TCA medications within the past three months
3. Use of pregabalin or gabapentin within the past three months
4. Presence of active dermatologic vulvar disease or vaginal infection
5. Untreated atrophic vaginitis (participants may undergo treatment and re-evaluation for enrollment if the condition is resolved)
6. Previous vestibulectomy
7. 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.
8. Active incarceration
9. Cancer within the past year.
10. Chemotherapy and/or radiation treatment within the past year.
11. Unstable medical condition (e.g., renal impairment, significant hematological disease, cardiovascular disease, hepatic insufficiency, neurological disorder, autoimmune disease, or respiratory illness)
12. Clear inflammatory states (e.g., morbid obesity)
13. Use of immunosuppressant medications
14. History of intolerance to nortriptyline, topical lidocaine, or topical estradiol
15. 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
16. Contraindications to the use of lidocaine or local anesthetics
17. Contraindications to the use of topical estrogen therapy
18. Post-menopausal, defined as no menses for 12 consecutive months or surgical removal of both ovaries. (Hysterectomy is not an exclusion)
19. Have not had Botox of the pelvic floor muscles in the last 12 months, or pelvic nerve blocks in the last three months.
20. Are not currently enrolled or planning to enroll in another clinical trial during the course of this trial.
21. Are not currently receiving pelvic physical therapy