World Health Organization site
Skip Navigation Links

Main
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 11 December 2023
Main ID:  NCT03844412
Date of registration: 15/02/2019
Prospective Registration: Yes
Primary sponsor: Duke University
Public title: Vestibulodynia: Understanding Pathophysiology and Determining Appropriate Treatments
Scientific title: Vestibulodynia: Understanding Pathophysiology and Determining Appropriate Treatments
Date of first enrolment: November 4, 2019
Target sample size: 400
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/ct2/show/NCT03844412
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Factorial Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).  
Phase:  Phase 2
Countries of recruitment
United States
Contacts
Name:     Andrea Nackley, PhD
Address: 
Telephone:
Email:
Affiliation:  Duke University
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 50 Years
Gender: Female
Health Condition(s) or Problem(s) studied
Fibromyalgia Syndrome
Interstitial Cystitis
Back Pain
Migraines
Temporomandibular Disorder
Irritable Bowel Syndrome
Tension Headache
Vestibulodynia
Chronic Fatigue Syndrome
Endometriosis
Intervention(s)
Drug: 5% lidocaine/5 mg/ml 0.02% estradiol compound cream
Drug: Nortriptyline
Drug: Placebo cream
Drug: Placebo pill
Primary Outcome(s)
Change in regulators of pro-pain and pro-inflammatory genes, as measured by microRNA expression levels [Time Frame: Baseline, 16 weeks]
Change in self-reported physical/mental health via SF-12 Health Survey (SF12v2) [Time Frame: Baseline, 16 weeks]
Change in sexual health via Patient-Reported Outcomes Measurement Information System (PROMIS) [Time Frame: Baseline, 16 weeks]
Change in inflammation as measured by cytokine expression levels [Time Frame: Baseline, 16 weeks]
Change in self-reported pain via the Short Form- McGill Pain Questionnaire (SF-MPQ) [Time Frame: Baseline, 16 weeks]
Change in pain score during the tampon test [Time Frame: Baseline, 16 weeks]
Secondary Outcome(s)
Levator Muscle Complex Pressure Pain Thresholds (PPTs) [Time Frame: Baseline, 8 weeks, 16 weeks, and 24 weeks]
Change in sleep as measured by the sleep scale [Time Frame: Baseline, 8 weeks, 16 weeks, and 24 weeks]
Change in degree of overlapping pain, as measured by COPC follow-up survey [Time Frame: Baseline, 8 weeks, 16 weeks, and 24 weeks]
Change in pain level as measured by Remote Bodily PPTs [Time Frame: Baseline, 8 weeks, 16 weeks, and 24 weeks]
Change in pain level as measured by Vaginal Vestibule Pressure Pain Intensities (PPI) [Time Frame: Baseline, 8 weeks, 16 weeks, and 24 weeks]
Change in cytokine biomarkers at other time points [Time Frame: 8 weeks and 24 weeks]
Change in in pain score during the tampon test at other time points [Time Frame: 8 weeks and 24 weeks]
Change in in pain score via the SF-MPQ at other time points [Time Frame: 8 weeks and 24 weeks]
Change in mood as measured by the Symptom Checklist-27 (SCL-27) [Time Frame: Baseline, 8 weeks, 16 weeks, and 24 weeks]
Change in self-reported health on the SF12v2 at other time points [Time Frame: 8 weeks and 24 weeks]
Change in somatic awareness via Pennebaker Index of Limbic Languidness (PILL) [Time Frame: Baseline, 8 weeks, 16 weeks, and 24 weeks]
Change in microRNA biomarkers at other time points [Time Frame: 8 weeks and 24 weeks]
Change in perceived stress via Perceived Stress Scale (PSS) [Time Frame: Baseline, 8 weeks, 16 weeks, and 24 weeks]
Change in self-reported health on the PROMIS at other time points [Time Frame: 8 weeks and 24 weeks]
Secondary ID(s)
1R01HD096331-01
Pro00100678
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history