Vestibulodynia: Understanding Pathophysiology and Determining Appropriate Treatments

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Treatments: Antidepressive Agents; Antidepressive Agents, Tricyclic; Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Lidocaine; Nortriptyline; Polyestradiol phosphate

Criteria

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