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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HD096331-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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 identified two distinct VBD subtypes that may benefit from different types of treatment: 1) VBD peripheral (VBD-p) subtype characterized by localized pain specific to the vulvar vestibule, and 2) VBD central (VBD-c) subtype characterized by pain at both vaginal and remote body regions. Preliminary data further demonstrate that VBD-p and VBD-c subtypes differ with respect to patient reported outcomes (e.g., physical and mental health), production of cytokines (intracellular proteins that regulate the activity of pain nerves and inflammatory processes), and expression of microRNAs (small non-coding RNA molecules that regulate gene expression). Women with VBD-p exhibit normal psychological profiles; balanced circulating pro- and anti-inflammatory cytokines; and dysregulation in microRNAs that regulate the expression of genes in estrogen pathways. In contrast, women with VBD-c report decreased functional status and increased somatization; increased pro-inflammatory but not anti-inflammatory cytokines; and dysregulation in microRNAs that regulate the expression of genes relevant to muscle, nerve, and immune cell function. Based on these data, the investigators hypothesize that two VBD-p and VBD-c subtypes will preferentially respond to peripheral, central, or combined treatments and can be distinguished by cytokine and microRNA profiles. These hypotheses will be tested in a phase III clinical trial that evaluates diverse treatment strategies in women with VBD-p and VBD-c. Participants will be randomly assigned to one of four parallel arms: peripheral treatment with 5% lidocaine + 0.5 mg/ml 0.02% estradiol compound cream, 2) central treatment with the tricyclic antidepressant nortriptyline, 3) combined peripheral and central treatments, or 4) placebo. The treatment phase will last 4 months (with a 6-week titration at treatment initiation and 2-week taper period at 4 months), with outcome measures and biomarkers assessed at 4 time points (0, 2, 4, and 6 months). First, the investigators will compare the efficacy of treatments in alleviating pain among women with VBD-p and VBD-c using standardized tampon insertion with a numeric rating scale and self-reported pain on the McGill Pain Questionnaire. Next, the investigators will compare the efficacy of treatments in improving perceived physical, mental, and sexual health among women with VBD-p and VBD-c using standardized questionnaires. Finally, investigators will measure cytokines and microRNAs in women with VBD-p versus VBD-c using multiplex assays and RNA sequencing, and determine the ability of these biomarkers to predict treatment response. Successful completion of the proposed work will provide new insights into the mechanisms that drive pain perception and treatment response in two distinct VBD subtypes, and determine the efficacy of peripheral, central, and combined therapies in reversing this pain. Such findings will readily translate to improved patient care, permitting the millions of women with VBD, their partners, and clinicians to make more informed decisions about pain management.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| peripheral treatment | Active Comparator | 5% lidocaine/5 mg/ml 0.02% estradiol compound cream |
|
| central treatment | Active Comparator | tricyclic antidepressant nortriptyline pill |
|
| combined peripheral and central treatments | Active Comparator | 5% lidocaine/5 mg/ml 0.02% estradiol compound cream and tricyclic antidepressant nortriptyline pill |
|
| placebo | Placebo Comparator | placebo cream and placebo pill |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5% lidocaine/5 mg/ml 0.02% estradiol compound cream | Drug | Lidocaine/estradiol cream targets peripheral nerves and tissues affected in VBD. Participants will be provided with a diagram and written instructions, detailing how to apply the cream to the vaginal vestibule daily for weeks 1-16. Treatment with lidocaine/estradiol or placebo cream will be terminated at week 16 (end of month 4). |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Score During the Tampon Test | The Tampon Test will provide a self-reported numeric rating scale of pain with self-tampon insertion, performed by the patient and reported to the research nurse. Participants will be asked to verbally rate the pain on a scale of 0-10, with 0 meaning no pain and 10 meaning the worst possible pain. | Baseline, 16 weeks |
| Change in Self-reported Pain Via the Short Form- McGill Pain Questionnaire (SF-MPQ) | The SF-MPQ consists of 15 descriptors which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe. The total score ranges from 0 to 45, where a higher score indicates greater pain. A negative change score indicates a decrease in pain over time. | Baseline, 16 weeks |
| Self-reported Physical Health Via SF-12 Health Survey (SF12v2) | The SF-12 physical health score has a mean of 50 and a standard deviation of 10 in the general population. Scores above 50 indicate a better-than-average health-related quality of life, while scores below 50 suggest below-average health. | Prior to randomization |
| Self-reported Mental Health Via SF-12 Health Survey (SF12v2) | The SF-12 mental health score has a mean of 50 and a standard deviation of 10 in the general population. Scores above 50 indicate a better-than-average health-related quality of life, while scores below 50 suggest below-average health. | Prior to randomization |
| Sexual Health Via Patient-Reported Outcomes Measurement Information System (PROMIS) | The PROMIS score is based on a 96-item form developed by the NIH that measures 11 domains of biopsychosocial function and includes an assessment of sexual function measures (e.g., desire, frequency, fear, and pain) related to sexual intercourse. The PROMIS Sexual Function and Satisfaction (SexFS) measures produce a T-score that summarizes a person's sexual health. The T-score is a standardized score that ranges from 0 to 100, where 50 indicates the population mean with a standard deviation of 10. Higher scores indicate greater satisfaction. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Level as Measured by Vaginal Vestibule Pressure Pain Intensities (PPI) | Vaginal Vestibule PPIs will be determined using a cotton swab applied to externally-accessed sites (at 10, 6, and 2 o'clock on the vestibule) for 1-2 seconds. Upon application of cotton swab at each site, participants will rate their pain intensity on a scale from 0-10, where 0 = no pain and 10 = the worst pain possible. Reported as a composite mean score. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Inflammation as Measured by Cytokine Expression Levels | Cytokine expression levels will be measured via mesoscale discovery assays. | Baseline, 16 weeks |
| Change in Cytokine Biomarkers at Other Time Points |
Inclusion Criteria
Female
Age 18-50 years
English-literate
Willingness to provide informed consent
Meeting criteria for diagnosis of VBD based on:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Andrea Nackley, PhD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Los Angeles | Los Angeles | California | 90095 | United States | ||
| University of North Carolina at Chapel Hill |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36269028 | Derived | Carey ET, Geller EJ, Rapkin A, Farb D, Cutting H, Akaninwor J, Stirling C, Bortsov A, McNulty S, Merrill P, Zakroysky P, DeLaRosa J, Luo S, Nackley AG. Rationale and design of a multicenter randomized clinical trial of vestibulodynia: understanding pathophysiology and determining appropriate treatments (vestibulodynia: UPDATe). Ann Med. 2022 Dec;54(1):2885-2897. doi: 10.1080/07853890.2022.2132531. |
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The investigators will share data in a manner consistent with NIH's policy NOT-OD-14-124, found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-124.html, released August 28, 2014. Genotypic data (e.g. microRNA and protein expression) and relevant phenotypic data (e.g. pain scores) from 400 participants will be posted on the dbGaP website.
The PI expects data release up to 6 months after data submission is initiated or at the time of acceptance of initial publication, whichever occurs first.
Requests to download individual unit-record datasets should be submitted to the PI and require approval from a Data Access Committee convened by the NIH/NICHD.
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| ID | Title | Description |
|---|---|---|
| FG000 | Combined Peripheral and Central Treatments | 5% lidocaine/5 mg/ml 0.02% estradiol compound cream and tricyclic antidepressant nortriptyline pill 5% lidocaine/5 mg/ml 0.02% estradiol compound cream: Lidocaine/estradiol cream targets peripheral nerves and tissues affected in VBD. Participants will be provided with a diagram and written instructions, detailing how to apply the cream to the vaginal vestibule daily for weeks 1-16. Treatment with lidocaine/estradiol or placebo cream will be terminated at week 16 (end of month 4). Nortriptyline: Nortriptyline is a centrally-acting tricyclic antidepressant that is FDA-approved for treatment of neuropathic pain. Dosing will begin with one 10 mg pill nightly for week 1, then two 10 mg pills nightly for week 2, three 10 mg pills nightly for week 3, four 10 mg pills nightly for week 4, and five for weeks 5 -16. Treatment with nortriptyline or placebo pill will be tapered off over weeks 16-18, decreasing the dose by 10 mg every 4 days. Participants will be provided with a list of drugs to avoid that are known to interact with nortriptyline. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 21, 2024 |
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Two-center, randomized, double-blind, placebo-controlled 2x2 factorial study enrolling 400 women to participate for 24-week duration.
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|
| Nortriptyline | Drug | Nortriptyline is a centrally-acting tricyclic antidepressant that is FDA-approved for treatment of neuropathic pain. Dosing will begin with one 10 mg pill nightly for week 1, then two 10 mg pills nightly for week 2, three 10 mg pills nightly for week 3, four 10 mg pills nightly for week 4, and five for weeks 5 -16. Treatment with nortriptyline or placebo pill will be tapered off over weeks 16-18, decreasing the dose by 10 mg every 4 days. Participants will be provided with a list of drugs to avoid that are known to interact with nortriptyline. |
|
| Placebo cream | Drug | The comparison treatment will be an identical-appearing placebo Moisturelâ„¢ cream |
|
|
| Placebo pill | Drug | The comparison treatment will be an identical-appearing placebo pill |
|
| Baseline, 16 weeks |
| Baseline, 8 weeks, and 16 weeks |
| Change in Levator Muscle Complex Pressure Pain Threshold (PPT) | Levator Muscle Complex PPTs will be determined using a digital vestibular algometer applied internally to the left puborectalis levator muscles site (7 o'clock) just lateral to the perineum. The test determines the amount of pressure over a given area in which a steadily increasing nonpainful pressure stimulus turns into a painful pressure sensation. | Baseline, 16 weeks |
| Change in Pain Level as Measured by Remote Bodily PPTs | Remote Bodily PPTs will be determined by applying the algometer to 3 'neutral' non-pelvic body sites (deltoid, shin, and trapezius), right and left, beginning at 1N and increasing until the participant's first sensation of pain. PPT scores are rated on a scale of 0-10, where 0 meaning no pain and 10 meaning the worst pain possible. Reported as a composite mean score. | Baseline, 8 weeks, and 16 weeks |
| Somatic Awareness Via Pennebaker Index of Limbic Languidness (PILL) | Pennebaker Index of Limbic Languidness (PILL) is used to create a summary score of somatic symptoms (e.g., itchy eyes, dizziness). Symptom frequency is recorded on a five-point Likert scale ranging from "never" (0) to "more than once a week" (4). The total score ranges from 0 to 216, where greater scores indicate greater frequency of symptoms. | Baseline, 8 weeks, and 16 weeks |
| Change in Sleep as Measured by the Sleep Scale | The sleep scale is a 12-item scale that measures amount of sleep and ease/difficulty of initiating and maintaining sleep. | Baseline, 8 weeks, 16 weeks, and 24 weeks |
| Change in Perceived Stress Via Perceived Stress Scale (PSS) | The Perceived stress scale (PSS) is a 10-item scale that measures the impact of personal stress on thoughts and feelings. | Baseline, 8 weeks, 16 weeks, and 24 weeks |
| Change in Mood as Measured by the Symptom Checklist-27 (SCL-27) | Symptom Check List 27 (SCL-27) questionnaire will be used to measure a broad range of psychological symptoms (e.g., anxiety and depression). | Baseline, 8 weeks, 16 weeks, and 24 weeks |
Change in cytokine levels will be measured as described above.
| 8 weeks and 24 weeks |
| Change in microRNA Biomarkers at Other Time Points | Change in microRNA levels will be measured as described above. | 8 weeks and 24 weeks |
| Change in Regulators of Pro-pain and Pro-inflammatory Genes, as Measured by microRNA Expression Levels | MicroRNA expression levels will be measured via sequencing read. | Baseline, 16 weeks |
| Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Headaches | Participants reported the change from previous timepoint in the degree of overlapping pain. Response options were: A Great Deal Worse, Moderately Worse, A Little Worse, No Change, A Little Better, Moderately Better, or A Great Deal Better. | Baseline, 8 weeks, 16 weeks, and 24 weeks |
| Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Widespread Pain | Participants reported the change from previous timepoint in the degree of overlapping pain. Response options were: A Great Deal Worse, Moderately Worse, A Little Worse, No Change, A Little Better, Moderately Better, or A Great Deal Better. | Baseline, 8 weeks, 16 weeks, and 24 weeks |
| Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Orofacial Pain | Participants reported the change from previous timepoint in the degree of overlapping pain. Response options were: A Great Deal Worse, Moderately Worse, A Little Worse, No Change, A Little Better, Moderately Better, or A Great Deal Better. | Baseline, 8 weeks, 16 weeks, and 24 weeks |
| Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Back Pain | Participants reported the change from previous timepoint in the degree of overlapping pain. Response options were: A Great Deal Worse, Moderately Worse, A Little Worse, No Change, A Little Better, Moderately Better, or A Great Deal Better. | Baseline, 8 weeks, 16 weeks, and 24 weeks |
| Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Abdominal Pain | Participants reported the change from previous timepoint in the degree of overlapping pain. Response options were: A Great Deal Worse, Moderately Worse, A Little Worse, No Change, A Little Better, Moderately Better, or A Great Deal Better. | Baseline, 8 weeks, 16 weeks, and 24 weeks |
| Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Bladder Pain | Participants reported the change from previous timepoint in the degree of overlapping pain. Response options were: A Great Deal Worse, Moderately Worse, A Little Worse, No Change, A Little Better, Moderately Better, or A Great Deal Better. | Baseline, 8 weeks, 16 weeks, and 24 weeks |
| Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Menstrual Pain | Participants reported the change from previous timepoint in the degree of overlapping pain. Response options were: A Great Deal Worse, Moderately Worse, A Little Worse, No Change, A Little Better, Moderately Better, or A Great Deal Better. | Baseline, 8 weeks, 16 weeks, and 24 weeks |
| Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Fatigue | Participants reported the change from previous timepoint in the degree of overlapping pain. Response options were: A Great Deal Worse, Moderately Worse, A Little Worse, No Change, A Little Better, Moderately Better, or A Great Deal Better. | Baseline, 8 weeks, 16 weeks, and 24 weeks |
| Chapel Hill |
| North Carolina |
| 27278 |
| United States |
| FG001 | Peripheral Treatment | 5% lidocaine/5 mg/ml 0.02% estradiol compound cream 5% lidocaine/5 mg/ml 0.02% estradiol compound cream: Lidocaine/estradiol cream targets peripheral nerves and tissues affected in VBD. Participants will be provided with a diagram and written instructions, detailing how to apply the cream to the vaginal vestibule daily for weeks 1-16. Treatment with lidocaine/estradiol or placebo cream will be terminated at week 16 (end of month 4). Placebo pill: The comparison treatment will be an identical-appearing placebo pill |
| FG002 | Central Treatment | tricyclic antidepressant nortriptyline pill Nortriptyline: Nortriptyline is a centrally-acting tricyclic antidepressant that is FDA-approved for treatment of neuropathic pain. Dosing will begin with one 10 mg pill nightly for week 1, then two 10 mg pills nightly for week 2, three 10 mg pills nightly for week 3, four 10 mg pills nightly for week 4, and five for weeks 5 -16. Treatment with nortriptyline or placebo pill will be tapered off over weeks 16-18, decreasing the dose by 10 mg every 4 days. Participants will be provided with a list of drugs to avoid that are known to interact with nortriptyline. Placebo cream: The comparison treatment will be an identical-appearing placebo Moisturelâ„¢ cream |
| FG003 | Placebo | placebo cream and placebo pill Placebo cream: The comparison treatment will be an identical-appearing placebo Moisturelâ„¢ cream Placebo pill: The comparison treatment will be an identical-appearing placebo pill |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Combined Peripheral and Central Treatments | 5% lidocaine/5 mg/ml 0.02% estradiol compound cream and tricyclic antidepressant nortriptyline pill 5% lidocaine/5 mg/ml 0.02% estradiol compound cream: Lidocaine/estradiol cream targets peripheral nerves and tissues affected in VBD. Participants will be provided with a diagram and written instructions, detailing how to apply the cream to the vaginal vestibule daily for weeks 1-16. Treatment with lidocaine/estradiol or placebo cream will be terminated at week 16 (end of month 4). Nortriptyline: Nortriptyline is a centrally-acting tricyclic antidepressant that is FDA-approved for treatment of neuropathic pain. Dosing will begin with one 10 mg pill nightly for week 1, then two 10 mg pills nightly for week 2, three 10 mg pills nightly for week 3, four 10 mg pills nightly for week 4, and five for weeks 5 -16. Treatment with nortriptyline or placebo pill will be tapered off over weeks 16-18, decreasing the dose by 10 mg every 4 days. Participants will be provided with a list of drugs to avoid that are known to interact with nortriptyline. |
| BG001 | Peripheral Treatment | 5% lidocaine/5 mg/ml 0.02% estradiol compound cream 5% lidocaine/5 mg/ml 0.02% estradiol compound cream: Lidocaine/estradiol cream targets peripheral nerves and tissues affected in VBD. Participants will be provided with a diagram and written instructions, detailing how to apply the cream to the vaginal vestibule daily for weeks 1-16. Treatment with lidocaine/estradiol or placebo cream will be terminated at week 16 (end of month 4). Placebo pill: The comparison treatment will be an identical-appearing placebo pill |
| BG002 | Central Treatment | tricyclic antidepressant nortriptyline pill Nortriptyline: Nortriptyline is a centrally-acting tricyclic antidepressant that is FDA-approved for treatment of neuropathic pain. Dosing will begin with one 10 mg pill nightly for week 1, then two 10 mg pills nightly for week 2, three 10 mg pills nightly for week 3, four 10 mg pills nightly for week 4, and five for weeks 5 -16. Treatment with nortriptyline or placebo pill will be tapered off over weeks 16-18, decreasing the dose by 10 mg every 4 days. Participants will be provided with a list of drugs to avoid that are known to interact with nortriptyline. Placebo cream: The comparison treatment will be an identical-appearing placebo Moisturelâ„¢ cream |
| BG003 | Placebo | placebo cream and placebo pill Placebo cream: The comparison treatment will be an identical-appearing placebo Moisturelâ„¢ cream Placebo pill: The comparison treatment will be an identical-appearing placebo pill |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Vestibulodynia Subtype | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pain Score During the Tampon Test | The Tampon Test will provide a self-reported numeric rating scale of pain with self-tampon insertion, performed by the patient and reported to the research nurse. Participants will be asked to verbally rate the pain on a scale of 0-10, with 0 meaning no pain and 10 meaning the worst possible pain. | Participants with data at both time points are included. | Posted | Mean | Standard Error | score on a scale | Baseline, 16 weeks |
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| Primary | Change in Self-reported Pain Via the Short Form- McGill Pain Questionnaire (SF-MPQ) | The SF-MPQ consists of 15 descriptors which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe. The total score ranges from 0 to 45, where a higher score indicates greater pain. A negative change score indicates a decrease in pain over time. | Participants with data collected at both timepoints. | Posted | Mean | Standard Error | score on a scale | Baseline, 16 weeks |
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| Primary | Self-reported Physical Health Via SF-12 Health Survey (SF12v2) | The SF-12 physical health score has a mean of 50 and a standard deviation of 10 in the general population. Scores above 50 indicate a better-than-average health-related quality of life, while scores below 50 suggest below-average health. | Data was collected prior to randomization. Therefore, data is reported by participant VBD subtype. | Posted | Mean | Standard Error | score on a scale | Prior to randomization |
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| Primary | Self-reported Mental Health Via SF-12 Health Survey (SF12v2) | The SF-12 mental health score has a mean of 50 and a standard deviation of 10 in the general population. Scores above 50 indicate a better-than-average health-related quality of life, while scores below 50 suggest below-average health. | Data was collected prior to randomization. Therefore, data is reported by participant VBD subtype. | Posted | Mean | Standard Error | score on a scale | Prior to randomization |
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| Primary | Sexual Health Via Patient-Reported Outcomes Measurement Information System (PROMIS) | The PROMIS score is based on a 96-item form developed by the NIH that measures 11 domains of biopsychosocial function and includes an assessment of sexual function measures (e.g., desire, frequency, fear, and pain) related to sexual intercourse. The PROMIS Sexual Function and Satisfaction (SexFS) measures produce a T-score that summarizes a person's sexual health. The T-score is a standardized score that ranges from 0 to 100, where 50 indicates the population mean with a standard deviation of 10. Higher scores indicate greater satisfaction. | Participants with data collected at each timepoint. | Posted | Mean | Standard Error | score on a scale | Baseline, 16 weeks |
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| Secondary | Change in Pain Level as Measured by Vaginal Vestibule Pressure Pain Intensities (PPI) | Vaginal Vestibule PPIs will be determined using a cotton swab applied to externally-accessed sites (at 10, 6, and 2 o'clock on the vestibule) for 1-2 seconds. Upon application of cotton swab at each site, participants will rate their pain intensity on a scale from 0-10, where 0 = no pain and 10 = the worst pain possible. Reported as a composite mean score. | Participants with data collected at both timepoints for each comparison. | Posted | Mean | Standard Error | score on a scale | Baseline, 8 weeks, and 16 weeks |
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| Secondary | Change in Levator Muscle Complex Pressure Pain Threshold (PPT) | Levator Muscle Complex PPTs will be determined using a digital vestibular algometer applied internally to the left puborectalis levator muscles site (7 o'clock) just lateral to the perineum. The test determines the amount of pressure over a given area in which a steadily increasing nonpainful pressure stimulus turns into a painful pressure sensation. | Participants with data collected at both timepoints. | Posted | Mean | Standard Error | kPa | Baseline, 16 weeks |
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| Secondary | Change in Pain Level as Measured by Remote Bodily PPTs | Remote Bodily PPTs will be determined by applying the algometer to 3 'neutral' non-pelvic body sites (deltoid, shin, and trapezius), right and left, beginning at 1N and increasing until the participant's first sensation of pain. PPT scores are rated on a scale of 0-10, where 0 meaning no pain and 10 meaning the worst pain possible. Reported as a composite mean score. | Participants with data collected at both timepoints for each comparison. | Posted | Mean | Standard Error | score on a scale | Baseline, 8 weeks, and 16 weeks |
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| Secondary | Somatic Awareness Via Pennebaker Index of Limbic Languidness (PILL) | Pennebaker Index of Limbic Languidness (PILL) is used to create a summary score of somatic symptoms (e.g., itchy eyes, dizziness). Symptom frequency is recorded on a five-point Likert scale ranging from "never" (0) to "more than once a week" (4). The total score ranges from 0 to 216, where greater scores indicate greater frequency of symptoms. | Participants with data collected at each timepoint. | Posted | Mean | Standard Error | score on a scale | Baseline, 8 weeks, and 16 weeks |
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| Secondary | Change in Sleep as Measured by the Sleep Scale | The sleep scale is a 12-item scale that measures amount of sleep and ease/difficulty of initiating and maintaining sleep. | Study team believed data was being collected, but sleep scale was inadvertently not included in the REDCap survey follow-ups. | Posted | Baseline, 8 weeks, 16 weeks, and 24 weeks |
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| Secondary | Change in Perceived Stress Via Perceived Stress Scale (PSS) | The Perceived stress scale (PSS) is a 10-item scale that measures the impact of personal stress on thoughts and feelings. | Study team believed data was being collected, but PSS was inadvertently not included in the REDCap survey follow-ups. | Posted | Baseline, 8 weeks, 16 weeks, and 24 weeks |
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| Secondary | Change in Mood as Measured by the Symptom Checklist-27 (SCL-27) | Symptom Check List 27 (SCL-27) questionnaire will be used to measure a broad range of psychological symptoms (e.g., anxiety and depression). | Study team believed data was being collected, but SCL-27 was inadvertently not included in the REDCap survey follow-ups. | Posted | Baseline, 8 weeks, 16 weeks, and 24 weeks |
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| Other Pre-specified | Change in Inflammation as Measured by Cytokine Expression Levels | Cytokine expression levels will be measured via mesoscale discovery assays. | Not Posted | Jun 2026 | Baseline, 16 weeks | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change in Cytokine Biomarkers at Other Time Points | Change in cytokine levels will be measured as described above. | Not Posted | Jun 2026 | 8 weeks and 24 weeks | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change in microRNA Biomarkers at Other Time Points | Change in microRNA levels will be measured as described above. | Not Posted | Jun 2026 | 8 weeks and 24 weeks | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change in Regulators of Pro-pain and Pro-inflammatory Genes, as Measured by microRNA Expression Levels | MicroRNA expression levels will be measured via sequencing read. | Not Posted | Jun 2026 | Baseline, 16 weeks | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Headaches | Participants reported the change from previous timepoint in the degree of overlapping pain. Response options were: A Great Deal Worse, Moderately Worse, A Little Worse, No Change, A Little Better, Moderately Better, or A Great Deal Better. | Participants who reported having headaches at initial assessment and had data collected at each timepoint. | Posted | Count of Participants | Participants | Baseline, 8 weeks, 16 weeks, and 24 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Widespread Pain | Participants reported the change from previous timepoint in the degree of overlapping pain. Response options were: A Great Deal Worse, Moderately Worse, A Little Worse, No Change, A Little Better, Moderately Better, or A Great Deal Better. | Participants who reported having widespread pain at initial assessment and had data collected at each timepoint. | Posted | Count of Participants | Participants | Baseline, 8 weeks, 16 weeks, and 24 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Orofacial Pain | Participants reported the change from previous timepoint in the degree of overlapping pain. Response options were: A Great Deal Worse, Moderately Worse, A Little Worse, No Change, A Little Better, Moderately Better, or A Great Deal Better. | Participants who reported having orofacial pain at initial assessment and had data collected at each timepoint. | Posted | Count of Participants | Participants | Baseline, 8 weeks, 16 weeks, and 24 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Back Pain | Participants reported the change from previous timepoint in the degree of overlapping pain. Response options were: A Great Deal Worse, Moderately Worse, A Little Worse, No Change, A Little Better, Moderately Better, or A Great Deal Better. | Participants who reported having back pain at initial assessment and had data collected at each timepoint. | Posted | Count of Participants | Participants | Baseline, 8 weeks, 16 weeks, and 24 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Abdominal Pain | Participants reported the change from previous timepoint in the degree of overlapping pain. Response options were: A Great Deal Worse, Moderately Worse, A Little Worse, No Change, A Little Better, Moderately Better, or A Great Deal Better. | Participants who reported having abdominal pain at initial assessment and had data collected at each timepoint. | Posted | Count of Participants | Participants | Baseline, 8 weeks, 16 weeks, and 24 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Bladder Pain | Participants reported the change from previous timepoint in the degree of overlapping pain. Response options were: A Great Deal Worse, Moderately Worse, A Little Worse, No Change, A Little Better, Moderately Better, or A Great Deal Better. | Participants who reported having bladder pain at initial assessment and had data collected at each timepoint. | Posted | Count of Participants | Participants | Baseline, 8 weeks, 16 weeks, and 24 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Menstrual Pain | Participants reported the change from previous timepoint in the degree of overlapping pain. Response options were: A Great Deal Worse, Moderately Worse, A Little Worse, No Change, A Little Better, Moderately Better, or A Great Deal Better. | Participants who reported having menstrual pain at initial assessment and had data collected at each timepoint. | Posted | Count of Participants | Participants | Baseline, 8 weeks, 16 weeks, and 24 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Fatigue | Participants reported the change from previous timepoint in the degree of overlapping pain. Response options were: A Great Deal Worse, Moderately Worse, A Little Worse, No Change, A Little Better, Moderately Better, or A Great Deal Better. | Participants who reported having fatigue at initial assessment and had data collected at each timepoint. | Posted | Count of Participants | Participants | Baseline, 8 weeks, 16 weeks, and 24 weeks |
|
24 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Combined Peripheral and Central Treatments | 5% lidocaine/5 mg/ml 0.02% estradiol compound cream and tricyclic antidepressant nortriptyline pill 5% lidocaine/5 mg/ml 0.02% estradiol compound cream: Lidocaine/estradiol cream targets peripheral nerves and tissues affected in VBD. Participants will be provided with a diagram and written instructions, detailing how to apply the cream to the vaginal vestibule daily for weeks 1-16. Treatment with lidocaine/estradiol or placebo cream will be terminated at week 16 (end of month 4). Nortriptyline: Nortriptyline is a centrally-acting tricyclic antidepressant that is FDA-approved for treatment of neuropathic pain. Dosing will begin with one 10 mg pill nightly for week 1, then two 10 mg pills nightly for week 2, three 10 mg pills nightly for week 3, four 10 mg pills nightly for week 4, and five for weeks 5 -16. Treatment with nortriptyline or placebo pill will be tapered off over weeks 16-18, decreasing the dose by 10 mg every 4 days. Participants will be provided with a list of drugs to avoid that are known to interact with nortriptyline. | 0 | 52 | 1 | 52 | 32 | 52 |
| EG001 | Peripheral Treatment | 5% lidocaine/5 mg/ml 0.02% estradiol compound cream 5% lidocaine/5 mg/ml 0.02% estradiol compound cream: Lidocaine/estradiol cream targets peripheral nerves and tissues affected in VBD. Participants will be provided with a diagram and written instructions, detailing how to apply the cream to the vaginal vestibule daily for weeks 1-16. Treatment with lidocaine/estradiol or placebo cream will be terminated at week 16 (end of month 4). Placebo pill: The comparison treatment will be an identical-appearing placebo pill | 0 | 52 | 0 | 52 | 19 | 52 |
| EG002 | Central Treatment | tricyclic antidepressant nortriptyline pill Nortriptyline: Nortriptyline is a centrally-acting tricyclic antidepressant that is FDA-approved for treatment of neuropathic pain. Dosing will begin with one 10 mg pill nightly for week 1, then two 10 mg pills nightly for week 2, three 10 mg pills nightly for week 3, four 10 mg pills nightly for week 4, and five for weeks 5 -16. Treatment with nortriptyline or placebo pill will be tapered off over weeks 16-18, decreasing the dose by 10 mg every 4 days. Participants will be provided with a list of drugs to avoid that are known to interact with nortriptyline. Placebo cream: The comparison treatment will be an identical-appearing placebo Moisturelâ„¢ cream | 0 | 52 | 1 | 52 | 33 | 52 |
| EG003 | Placebo | placebo cream and placebo pill Placebo cream: The comparison treatment will be an identical-appearing placebo Moisturelâ„¢ cream Placebo pill: The comparison treatment will be an identical-appearing placebo pill | 0 | 53 | 0 | 53 | 27 | 53 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Seizure | Nervous system disorders | Non-systematic Assessment |
| ||
| Severe Acute Pancreatitis | Endocrine disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Swelling | General disorders | Non-systematic Assessment |
| ||
| Burning | General disorders | Non-systematic Assessment |
| ||
| Blistering | General disorders | Non-systematic Assessment |
| ||
| Drowsiness | General disorders | Non-systematic Assessment |
| ||
| Insomnia | General disorders | Non-systematic Assessment |
| ||
| Cloudy Thinking | General disorders | Non-systematic Assessment |
| ||
| Dry Mouth | General disorders | Non-systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Loss of Appetite | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Weight Gain | General disorders | Non-systematic Assessment |
| ||
| Weight Loss | General disorders | Non-systematic Assessment |
| ||
| Anxiety | Psychiatric disorders | Non-systematic Assessment |
| ||
| Hives | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Difficulty Urinating | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Vision Changes | Eye disorders | Non-systematic Assessment |
| ||
| Breast Swelling | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Decreased Sexual Drive | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Low Blood Sugar | Endocrine disorders | Non-systematic Assessment |
| ||
| High Blood Sugar | Endocrine disorders | Non-systematic Assessment |
| ||
| Increased Heart Rate | Cardiac disorders | Non-systematic Assessment |
| ||
| Irregular Heart Beat | Cardiac disorders | Non-systematic Assessment |
| ||
| Suicidal Thinking | Psychiatric disorders | Non-systematic Assessment |
| ||
| Mania | Psychiatric disorders | Non-systematic Assessment |
| ||
| Agitation | Psychiatric disorders | Non-systematic Assessment |
| ||
| Hallucinations | Psychiatric disorders | Non-systematic Assessment |
| ||
| Muscle Rigidity | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Seizures | Nervous system disorders | Non-systematic Assessment |
| ||
| Bone Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Dizziness | General disorders | Non-systematic Assessment |
| ||
| Serotonergic Symptoms | Nervous system disorders | Non-systematic Assessment |
| ||
| Headaches | General disorders | Non-systematic Assessment |
| ||
| Sensations of Cold Temperatures at the Site | Nervous system disorders | Non-systematic Assessment |
| ||
| Numbness at the Site as Medication is Applied | Nervous system disorders | Non-systematic Assessment |
| ||
| Confusion | General disorders | Non-systematic Assessment |
| ||
| Other | General disorders | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrea Nackley, PhD | Duke University | 919-613-5911 | andrea.nackley@duke.edu |
| Jan 8, 2025 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D056650 | Vulvodynia |
| D013705 | Temporomandibular Joint Disorders |
| D005356 | Fibromyalgia |
| D043183 | Irritable Bowel Syndrome |
| D008881 | Migraine Disorders |
| D018781 | Tension-Type Headache |
| D004715 | Endometriosis |
| D018856 | Cystitis, Interstitial |
| D001416 | Back Pain |
| D015673 | Fatigue Syndrome, Chronic |
| D017699 | Pelvic Pain |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D014845 | Vulvar Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D017271 | Craniomandibular Disorders |
| D008336 | Mandibular Diseases |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D007592 | Joint Diseases |
| D009135 | Muscular Diseases |
| D009057 | Stomatognathic Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D003556 | Cystitis |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004679 | Encephalomyelitis |
| D000090862 | Neuroinflammatory Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
Not provided
Not provided
| ID | Term |
|---|---|
| D009661 | Nortriptyline |
| ID | Term |
|---|---|
| D003986 | Dibenzocycloheptenes |
| D001567 | Benzocycloheptenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Peripheral |
|
| 16 weeks |
|
| Peripheral Treatment |
5% lidocaine/5 mg/ml 0.02% estradiol compound cream 5% lidocaine/5 mg/ml 0.02% estradiol compound cream: Lidocaine/estradiol cream targets peripheral nerves and tissues affected in VBD. Participants will be provided with a diagram and written instructions, detailing how to apply the cream to the vaginal vestibule daily for weeks 1-16. Treatment with lidocaine/estradiol or placebo cream will be terminated at week 16 (end of month 4). Placebo pill: The comparison treatment will be an identical-appearing placebo pill |
| OG002 | Central Treatment | Tricyclic antidepressant nortriptyline pill Nortriptyline: Nortriptyline is a centrally-acting tricyclic antidepressant that is FDA-approved for treatment of neuropathic pain. Dosing will begin with one 10 mg pill nightly for week 1, then two 10 mg pills nightly for week 2, three 10 mg pills nightly for week 3, four 10 mg pills nightly for week 4, and five for weeks 5 -16. Treatment with nortriptyline or placebo pill will be tapered off over weeks 16-18, decreasing the dose by 10 mg every 4 days. Participants will be provided with a list of drugs to avoid that are known to interact with nortriptyline. Placebo cream: The comparison treatment will be an identical-appearing placebo Moisturelâ„¢ cream |
| OG003 | Placebo | Placebo cream and placebo pill Placebo cream: The comparison treatment will be an identical-appearing placebo Moisturelâ„¢ cream Placebo pill: The comparison treatment will be an identical-appearing placebo pill |
|
|
|
|
|
|
|
| OG001 | Peripheral Treatment | 5% lidocaine/5 mg/ml 0.02% estradiol compound cream 5% lidocaine/5 mg/ml 0.02% estradiol compound cream: Lidocaine/estradiol cream targets peripheral nerves and tissues affected in VBD. Participants will be provided with a diagram and written instructions, detailing how to apply the cream to the vaginal vestibule daily for weeks 1-16. Treatment with lidocaine/estradiol or placebo cream will be terminated at week 16 (end of month 4). Placebo pill: The comparison treatment will be an identical-appearing placebo pill |
| OG002 | Central Treatment | Tricyclic antidepressant nortriptyline pill Nortriptyline: Nortriptyline is a centrally-acting tricyclic antidepressant that is FDA-approved for treatment of neuropathic pain. Dosing will begin with one 10 mg pill nightly for week 1, then two 10 mg pills nightly for week 2, three 10 mg pills nightly for week 3, four 10 mg pills nightly for week 4, and five for weeks 5 -16. Treatment with nortriptyline or placebo pill will be tapered off over weeks 16-18, decreasing the dose by 10 mg every 4 days. Participants will be provided with a list of drugs to avoid that are known to interact with nortriptyline. Placebo cream: The comparison treatment will be an identical-appearing placebo Moisturelâ„¢ cream |
| OG003 | Placebo | Placebo cream and placebo pill Placebo cream: The comparison treatment will be an identical-appearing placebo Moisturelâ„¢ cream Placebo pill: The comparison treatment will be an identical-appearing placebo pill |
|
|
|
| OG001 | Peripheral Treatment | 5% lidocaine/5 mg/ml 0.02% estradiol compound cream 5% lidocaine/5 mg/ml 0.02% estradiol compound cream: Lidocaine/estradiol cream targets peripheral nerves and tissues affected in VBD. Participants will be provided with a diagram and written instructions, detailing how to apply the cream to the vaginal vestibule daily for weeks 1-16. Treatment with lidocaine/estradiol or placebo cream will be terminated at week 16 (end of month 4). Placebo pill: The comparison treatment will be an identical-appearing placebo pill |
| OG002 | Central Treatment | Tricyclic antidepressant nortriptyline pill Nortriptyline: Nortriptyline is a centrally-acting tricyclic antidepressant that is FDA-approved for treatment of neuropathic pain. Dosing will begin with one 10 mg pill nightly for week 1, then two 10 mg pills nightly for week 2, three 10 mg pills nightly for week 3, four 10 mg pills nightly for week 4, and five for weeks 5 -16. Treatment with nortriptyline or placebo pill will be tapered off over weeks 16-18, decreasing the dose by 10 mg every 4 days. Participants will be provided with a list of drugs to avoid that are known to interact with nortriptyline. Placebo cream: The comparison treatment will be an identical-appearing placebo Moisturelâ„¢ cream |
| OG003 | Placebo | Placebo cream and placebo pill Placebo cream: The comparison treatment will be an identical-appearing placebo Moisturelâ„¢ cream Placebo pill: The comparison treatment will be an identical-appearing placebo pill |
|
|
|
| OG001 |
| Peripheral Treatment |
5% lidocaine/5 mg/ml 0.02% estradiol compound cream 5% lidocaine/5 mg/ml 0.02% estradiol compound cream: Lidocaine/estradiol cream targets peripheral nerves and tissues affected in VBD. Participants will be provided with a diagram and written instructions, detailing how to apply the cream to the vaginal vestibule daily for weeks 1-16. Treatment with lidocaine/estradiol or placebo cream will be terminated at week 16 (end of month 4). Placebo pill: The comparison treatment will be an identical-appearing placebo pill |
| OG002 | Central Treatment | Tricyclic antidepressant nortriptyline pill Nortriptyline: Nortriptyline is a centrally-acting tricyclic antidepressant that is FDA-approved for treatment of neuropathic pain. Dosing will begin with one 10 mg pill nightly for week 1, then two 10 mg pills nightly for week 2, three 10 mg pills nightly for week 3, four 10 mg pills nightly for week 4, and five for weeks 5 -16. Treatment with nortriptyline or placebo pill will be tapered off over weeks 16-18, decreasing the dose by 10 mg every 4 days. Participants will be provided with a list of drugs to avoid that are known to interact with nortriptyline. Placebo cream: The comparison treatment will be an identical-appearing placebo Moisturelâ„¢ cream |
| OG003 | Placebo | Placebo cream and placebo pill Placebo cream: The comparison treatment will be an identical-appearing placebo Moisturelâ„¢ cream Placebo pill: The comparison treatment will be an identical-appearing placebo pill |
|
|
| OG001 | Peripheral Treatment | 5% lidocaine/5 mg/ml 0.02% estradiol compound cream 5% lidocaine/5 mg/ml 0.02% estradiol compound cream: Lidocaine/estradiol cream targets peripheral nerves and tissues affected in VBD. Participants will be provided with a diagram and written instructions, detailing how to apply the cream to the vaginal vestibule daily for weeks 1-16. Treatment with lidocaine/estradiol or placebo cream will be terminated at week 16 (end of month 4). Placebo pill: The comparison treatment will be an identical-appearing placebo pill |
| OG002 | Central Treatment | Tricyclic antidepressant nortriptyline pill Nortriptyline: Nortriptyline is a centrally-acting tricyclic antidepressant that is FDA-approved for treatment of neuropathic pain. Dosing will begin with one 10 mg pill nightly for week 1, then two 10 mg pills nightly for week 2, three 10 mg pills nightly for week 3, four 10 mg pills nightly for week 4, and five for weeks 5 -16. Treatment with nortriptyline or placebo pill will be tapered off over weeks 16-18, decreasing the dose by 10 mg every 4 days. Participants will be provided with a list of drugs to avoid that are known to interact with nortriptyline. Placebo cream: The comparison treatment will be an identical-appearing placebo Moisturelâ„¢ cream |
| OG003 | Placebo | Placebo cream and placebo pill Placebo cream: The comparison treatment will be an identical-appearing placebo Moisturelâ„¢ cream Placebo pill: The comparison treatment will be an identical-appearing placebo pill |
|
|
|
| OG001 | Peripheral Treatment | 5% lidocaine/5 mg/ml 0.02% estradiol compound cream 5% lidocaine/5 mg/ml 0.02% estradiol compound cream: Lidocaine/estradiol cream targets peripheral nerves and tissues affected in VBD. Participants will be provided with a diagram and written instructions, detailing how to apply the cream to the vaginal vestibule daily for weeks 1-16. Treatment with lidocaine/estradiol or placebo cream will be terminated at week 16 (end of month 4). Placebo pill: The comparison treatment will be an identical-appearing placebo pill |
| OG002 | Central Treatment | Tricyclic antidepressant nortriptyline pill Nortriptyline: Nortriptyline is a centrally-acting tricyclic antidepressant that is FDA-approved for treatment of neuropathic pain. Dosing will begin with one 10 mg pill nightly for week 1, then two 10 mg pills nightly for week 2, three 10 mg pills nightly for week 3, four 10 mg pills nightly for week 4, and five for weeks 5 -16. Treatment with nortriptyline or placebo pill will be tapered off over weeks 16-18, decreasing the dose by 10 mg every 4 days. Participants will be provided with a list of drugs to avoid that are known to interact with nortriptyline. Placebo cream: The comparison treatment will be an identical-appearing placebo Moisturelâ„¢ cream |
| OG003 | Placebo | Placebo cream and placebo pill Placebo cream: The comparison treatment will be an identical-appearing placebo Moisturelâ„¢ cream Placebo pill: The comparison treatment will be an identical-appearing placebo pill |
|
|
5% lidocaine/5 mg/ml 0.02% estradiol compound cream
5% lidocaine/5 mg/ml 0.02% estradiol compound cream: Lidocaine/estradiol cream targets peripheral nerves and tissues affected in VBD. Participants will be provided with a diagram and written instructions, detailing how to apply the cream to the vaginal vestibule daily for weeks 1-16. Treatment with lidocaine/estradiol or placebo cream will be terminated at week 16 (end of month 4).
Placebo pill: The comparison treatment will be an identical-appearing placebo pill
| OG002 | Central Treatment | tricyclic antidepressant nortriptyline pill Nortriptyline: Nortriptyline is a centrally-acting tricyclic antidepressant that is FDA-approved for treatment of neuropathic pain. Dosing will begin with one 10 mg pill nightly for week 1, then two 10 mg pills nightly for week 2, three 10 mg pills nightly for week 3, four 10 mg pills nightly for week 4, and five for weeks 5 -16. Treatment with nortriptyline or placebo pill will be tapered off over weeks 16-18, decreasing the dose by 10 mg every 4 days. Participants will be provided with a list of drugs to avoid that are known to interact with nortriptyline. Placebo cream: The comparison treatment will be an identical-appearing placebo Moisturelâ„¢ cream |
| OG003 | Placebo | placebo cream and placebo pill Placebo cream: The comparison treatment will be an identical-appearing placebo Moisturelâ„¢ cream Placebo pill: The comparison treatment will be an identical-appearing placebo pill |
|
5% lidocaine/5 mg/ml 0.02% estradiol compound cream
5% lidocaine/5 mg/ml 0.02% estradiol compound cream: Lidocaine/estradiol cream targets peripheral nerves and tissues affected in VBD. Participants will be provided with a diagram and written instructions, detailing how to apply the cream to the vaginal vestibule daily for weeks 1-16. Treatment with lidocaine/estradiol or placebo cream will be terminated at week 16 (end of month 4).
Placebo pill: The comparison treatment will be an identical-appearing placebo pill
| OG002 | Central Treatment | tricyclic antidepressant nortriptyline pill Nortriptyline: Nortriptyline is a centrally-acting tricyclic antidepressant that is FDA-approved for treatment of neuropathic pain. Dosing will begin with one 10 mg pill nightly for week 1, then two 10 mg pills nightly for week 2, three 10 mg pills nightly for week 3, four 10 mg pills nightly for week 4, and five for weeks 5 -16. Treatment with nortriptyline or placebo pill will be tapered off over weeks 16-18, decreasing the dose by 10 mg every 4 days. Participants will be provided with a list of drugs to avoid that are known to interact with nortriptyline. Placebo cream: The comparison treatment will be an identical-appearing placebo Moisturelâ„¢ cream |
| OG003 | Placebo | placebo cream and placebo pill Placebo cream: The comparison treatment will be an identical-appearing placebo Moisturelâ„¢ cream Placebo pill: The comparison treatment will be an identical-appearing placebo pill |
|
5% lidocaine/5 mg/ml 0.02% estradiol compound cream 5% lidocaine/5 mg/ml 0.02% estradiol compound cream: Lidocaine/estradiol cream targets peripheral nerves and tissues affected in VBD. Participants will be provided with a diagram and written instructions, detailing how to apply the cream to the vaginal vestibule daily for weeks 1-16. Treatment with lidocaine/estradiol or placebo cream will be terminated at week 16 (end of month 4). Placebo pill: The comparison treatment will be an identical-appearing placebo pill |
| OG002 | Central Treatment | tricyclic antidepressant nortriptyline pill Nortriptyline: Nortriptyline is a centrally-acting tricyclic antidepressant that is FDA-approved for treatment of neuropathic pain. Dosing will begin with one 10 mg pill nightly for week 1, then two 10 mg pills nightly for week 2, three 10 mg pills nightly for week 3, four 10 mg pills nightly for week 4, and five for weeks 5 -16. Treatment with nortriptyline or placebo pill will be tapered off over weeks 16-18, decreasing the dose by 10 mg every 4 days. Participants will be provided with a list of drugs to avoid that are known to interact with nortriptyline. Placebo cream: The comparison treatment will be an identical-appearing placebo Moisturelâ„¢ cream |
| OG003 | Placebo | placebo cream and placebo pill Placebo cream: The comparison treatment will be an identical-appearing placebo Moisturelâ„¢ cream Placebo pill: The comparison treatment will be an identical-appearing placebo pill |
|
| OG001 | Peripheral Treatment | 5% lidocaine/5 mg/ml 0.02% estradiol compound cream 5% lidocaine/5 mg/ml 0.02% estradiol compound cream: Lidocaine/estradiol cream targets peripheral nerves and tissues affected in VBD. Participants will be provided with a diagram and written instructions, detailing how to apply the cream to the vaginal vestibule daily for weeks 1-16. Treatment with lidocaine/estradiol or placebo cream will be terminated at week 16 (end of month 4). Placebo pill: The comparison treatment will be an identical-appearing placebo pill |
| OG002 | Central Treatment | Tricyclic antidepressant nortriptyline pill Nortriptyline: Nortriptyline is a centrally-acting tricyclic antidepressant that is FDA-approved for treatment of neuropathic pain. Dosing will begin with one 10 mg pill nightly for week 1, then two 10 mg pills nightly for week 2, three 10 mg pills nightly for week 3, four 10 mg pills nightly for week 4, and five for weeks 5 -16. Treatment with nortriptyline or placebo pill will be tapered off over weeks 16-18, decreasing the dose by 10 mg every 4 days. Participants will be provided with a list of drugs to avoid that are known to interact with nortriptyline. Placebo cream: The comparison treatment will be an identical-appearing placebo Moisturelâ„¢ cream |
| OG003 | Placebo | Placebo cream and placebo pill Placebo cream: The comparison treatment will be an identical-appearing placebo Moisturelâ„¢ cream Placebo pill: The comparison treatment will be an identical-appearing placebo pill |
|
|
| OG001 | Peripheral Treatment | 5% lidocaine/5 mg/ml 0.02% estradiol compound cream 5% lidocaine/5 mg/ml 0.02% estradiol compound cream: Lidocaine/estradiol cream targets peripheral nerves and tissues affected in VBD. Participants will be provided with a diagram and written instructions, detailing how to apply the cream to the vaginal vestibule daily for weeks 1-16. Treatment with lidocaine/estradiol or placebo cream will be terminated at week 16 (end of month 4). Placebo pill: The comparison treatment will be an identical-appearing placebo pill |
| OG002 | Central Treatment | Tricyclic antidepressant nortriptyline pill Nortriptyline: Nortriptyline is a centrally-acting tricyclic antidepressant that is FDA-approved for treatment of neuropathic pain. Dosing will begin with one 10 mg pill nightly for week 1, then two 10 mg pills nightly for week 2, three 10 mg pills nightly for week 3, four 10 mg pills nightly for week 4, and five for weeks 5 -16. Treatment with nortriptyline or placebo pill will be tapered off over weeks 16-18, decreasing the dose by 10 mg every 4 days. Participants will be provided with a list of drugs to avoid that are known to interact with nortriptyline. Placebo cream: The comparison treatment will be an identical-appearing placebo Moisturelâ„¢ cream |
| OG003 | Placebo | Placebo cream and placebo pill Placebo cream: The comparison treatment will be an identical-appearing placebo Moisturelâ„¢ cream Placebo pill: The comparison treatment will be an identical-appearing placebo pill |
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| OG001 | Peripheral Treatment | 5% lidocaine/5 mg/ml 0.02% estradiol compound cream 5% lidocaine/5 mg/ml 0.02% estradiol compound cream: Lidocaine/estradiol cream targets peripheral nerves and tissues affected in VBD. Participants will be provided with a diagram and written instructions, detailing how to apply the cream to the vaginal vestibule daily for weeks 1-16. Treatment with lidocaine/estradiol or placebo cream will be terminated at week 16 (end of month 4). Placebo pill: The comparison treatment will be an identical-appearing placebo pill |
| OG002 | Central Treatment | Tricyclic antidepressant nortriptyline pill Nortriptyline: Nortriptyline is a centrally-acting tricyclic antidepressant that is FDA-approved for treatment of neuropathic pain. Dosing will begin with one 10 mg pill nightly for week 1, then two 10 mg pills nightly for week 2, three 10 mg pills nightly for week 3, four 10 mg pills nightly for week 4, and five for weeks 5 -16. Treatment with nortriptyline or placebo pill will be tapered off over weeks 16-18, decreasing the dose by 10 mg every 4 days. Participants will be provided with a list of drugs to avoid that are known to interact with nortriptyline. Placebo cream: The comparison treatment will be an identical-appearing placebo Moisturelâ„¢ cream |
| OG003 | Placebo | Placebo cream and placebo pill Placebo cream: The comparison treatment will be an identical-appearing placebo Moisturelâ„¢ cream Placebo pill: The comparison treatment will be an identical-appearing placebo pill |
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| OG001 | Peripheral Treatment | 5% lidocaine/5 mg/ml 0.02% estradiol compound cream 5% lidocaine/5 mg/ml 0.02% estradiol compound cream: Lidocaine/estradiol cream targets peripheral nerves and tissues affected in VBD. Participants will be provided with a diagram and written instructions, detailing how to apply the cream to the vaginal vestibule daily for weeks 1-16. Treatment with lidocaine/estradiol or placebo cream will be terminated at week 16 (end of month 4). Placebo pill: The comparison treatment will be an identical-appearing placebo pill |
| OG002 | Central Treatment | Tricyclic antidepressant nortriptyline pill Nortriptyline: Nortriptyline is a centrally-acting tricyclic antidepressant that is FDA-approved for treatment of neuropathic pain. Dosing will begin with one 10 mg pill nightly for week 1, then two 10 mg pills nightly for week 2, three 10 mg pills nightly for week 3, four 10 mg pills nightly for week 4, and five for weeks 5 -16. Treatment with nortriptyline or placebo pill will be tapered off over weeks 16-18, decreasing the dose by 10 mg every 4 days. Participants will be provided with a list of drugs to avoid that are known to interact with nortriptyline. Placebo cream: The comparison treatment will be an identical-appearing placebo Moisturelâ„¢ cream |
| OG003 | Placebo | Placebo cream and placebo pill Placebo cream: The comparison treatment will be an identical-appearing placebo Moisturelâ„¢ cream Placebo pill: The comparison treatment will be an identical-appearing placebo pill |
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| OG001 | Peripheral Treatment | 5% lidocaine/5 mg/ml 0.02% estradiol compound cream 5% lidocaine/5 mg/ml 0.02% estradiol compound cream: Lidocaine/estradiol cream targets peripheral nerves and tissues affected in VBD. Participants will be provided with a diagram and written instructions, detailing how to apply the cream to the vaginal vestibule daily for weeks 1-16. Treatment with lidocaine/estradiol or placebo cream will be terminated at week 16 (end of month 4). Placebo pill: The comparison treatment will be an identical-appearing placebo pill |
| OG002 | Central Treatment | Tricyclic antidepressant nortriptyline pill Nortriptyline: Nortriptyline is a centrally-acting tricyclic antidepressant that is FDA-approved for treatment of neuropathic pain. Dosing will begin with one 10 mg pill nightly for week 1, then two 10 mg pills nightly for week 2, three 10 mg pills nightly for week 3, four 10 mg pills nightly for week 4, and five for weeks 5 -16. Treatment with nortriptyline or placebo pill will be tapered off over weeks 16-18, decreasing the dose by 10 mg every 4 days. Participants will be provided with a list of drugs to avoid that are known to interact with nortriptyline. Placebo cream: The comparison treatment will be an identical-appearing placebo Moisturelâ„¢ cream |
| OG003 | Placebo | Placebo cream and placebo pill Placebo cream: The comparison treatment will be an identical-appearing placebo Moisturelâ„¢ cream Placebo pill: The comparison treatment will be an identical-appearing placebo pill |
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| OG001 | Peripheral Treatment | 5% lidocaine/5 mg/ml 0.02% estradiol compound cream 5% lidocaine/5 mg/ml 0.02% estradiol compound cream: Lidocaine/estradiol cream targets peripheral nerves and tissues affected in VBD. Participants will be provided with a diagram and written instructions, detailing how to apply the cream to the vaginal vestibule daily for weeks 1-16. Treatment with lidocaine/estradiol or placebo cream will be terminated at week 16 (end of month 4). Placebo pill: The comparison treatment will be an identical-appearing placebo pill |
| OG002 | Central Treatment | Tricyclic antidepressant nortriptyline pill Nortriptyline: Nortriptyline is a centrally-acting tricyclic antidepressant that is FDA-approved for treatment of neuropathic pain. Dosing will begin with one 10 mg pill nightly for week 1, then two 10 mg pills nightly for week 2, three 10 mg pills nightly for week 3, four 10 mg pills nightly for week 4, and five for weeks 5 -16. Treatment with nortriptyline or placebo pill will be tapered off over weeks 16-18, decreasing the dose by 10 mg every 4 days. Participants will be provided with a list of drugs to avoid that are known to interact with nortriptyline. Placebo cream: The comparison treatment will be an identical-appearing placebo Moisturelâ„¢ cream |
| OG003 | Placebo | Placebo cream and placebo pill Placebo cream: The comparison treatment will be an identical-appearing placebo Moisturelâ„¢ cream Placebo pill: The comparison treatment will be an identical-appearing placebo pill |
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| OG001 | Peripheral Treatment | 5% lidocaine/5 mg/ml 0.02% estradiol compound cream 5% lidocaine/5 mg/ml 0.02% estradiol compound cream: Lidocaine/estradiol cream targets peripheral nerves and tissues affected in VBD. Participants will be provided with a diagram and written instructions, detailing how to apply the cream to the vaginal vestibule daily for weeks 1-16. Treatment with lidocaine/estradiol or placebo cream will be terminated at week 16 (end of month 4). Placebo pill: The comparison treatment will be an identical-appearing placebo pill |
| OG002 | Central Treatment | Tricyclic antidepressant nortriptyline pill Nortriptyline: Nortriptyline is a centrally-acting tricyclic antidepressant that is FDA-approved for treatment of neuropathic pain. Dosing will begin with one 10 mg pill nightly for week 1, then two 10 mg pills nightly for week 2, three 10 mg pills nightly for week 3, four 10 mg pills nightly for week 4, and five for weeks 5 -16. Treatment with nortriptyline or placebo pill will be tapered off over weeks 16-18, decreasing the dose by 10 mg every 4 days. Participants will be provided with a list of drugs to avoid that are known to interact with nortriptyline. Placebo cream: The comparison treatment will be an identical-appearing placebo Moisturelâ„¢ cream |
| OG003 | Placebo | Placebo cream and placebo pill Placebo cream: The comparison treatment will be an identical-appearing placebo Moisturelâ„¢ cream Placebo pill: The comparison treatment will be an identical-appearing placebo pill |
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| OG001 | Peripheral Treatment | 5% lidocaine/5 mg/ml 0.02% estradiol compound cream 5% lidocaine/5 mg/ml 0.02% estradiol compound cream: Lidocaine/estradiol cream targets peripheral nerves and tissues affected in VBD. Participants will be provided with a diagram and written instructions, detailing how to apply the cream to the vaginal vestibule daily for weeks 1-16. Treatment with lidocaine/estradiol or placebo cream will be terminated at week 16 (end of month 4). Placebo pill: The comparison treatment will be an identical-appearing placebo pill |
| OG002 | Central Treatment | Tricyclic antidepressant nortriptyline pill Nortriptyline: Nortriptyline is a centrally-acting tricyclic antidepressant that is FDA-approved for treatment of neuropathic pain. Dosing will begin with one 10 mg pill nightly for week 1, then two 10 mg pills nightly for week 2, three 10 mg pills nightly for week 3, four 10 mg pills nightly for week 4, and five for weeks 5 -16. Treatment with nortriptyline or placebo pill will be tapered off over weeks 16-18, decreasing the dose by 10 mg every 4 days. Participants will be provided with a list of drugs to avoid that are known to interact with nortriptyline. Placebo cream: The comparison treatment will be an identical-appearing placebo Moisturelâ„¢ cream |
| OG003 | Placebo | Placebo cream and placebo pill Placebo cream: The comparison treatment will be an identical-appearing placebo Moisturelâ„¢ cream Placebo pill: The comparison treatment will be an identical-appearing placebo pill |
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| Title | Measurements |
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| Title | Measurements |
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| Title | Measurements |
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| Title | Measurements |
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| Moderately Worse |
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| A Little Worse |
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| No Change |
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| A Little Better |
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| Moderately Better |
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| A Great Deal Better |
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| Title | Measurements |
|---|---|
| A Great Deal Worse |
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| Moderately Worse |
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| A Little Worse |
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| No Change |
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| A Little Better |
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| Moderately Better |
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| A Great Deal Better |
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| Title | Measurements |
|---|---|
| A Great Deal Worse |
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| Moderately Worse |
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| A Little Worse |
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| No Change |
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| A Little Better |
|
| Moderately Better |
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| A Great Deal Better |
|
| Moderately Worse |
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| A Little Worse |
|
| No Change |
|
| A Little Better |
|
| Moderately Better |
|
| A Great Deal Better |
|
| Title | Measurements |
|---|---|
| A Great Deal Worse |
|
| Moderately Worse |
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| A Little Worse |
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| No Change |
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| A Little Better |
|
| Moderately Better |
|
| A Great Deal Better |
|
| Title | Measurements |
|---|---|
| A Great Deal Worse |
|
| Moderately Worse |
|
| A Little Worse |
|
| No Change |
|
| A Little Better |
|
| Moderately Better |
|
| A Great Deal Better |
|
| Moderately Worse |
|
| A Little Worse |
|
| No Change |
|
| A Little Better |
|
| Moderately Better |
|
| A Great Deal Better |
|
| Title | Measurements |
|---|---|
| A Great Deal Worse |
|
| Moderately Worse |
|
| A Little Worse |
|
| No Change |
|
| A Little Better |
|
| Moderately Better |
|
| A Great Deal Better |
|
| Title | Measurements |
|---|---|
| A Great Deal Worse |
|
| Moderately Worse |
|
| A Little Worse |
|
| No Change |
|
| A Little Better |
|
| Moderately Better |
|
| A Great Deal Better |
|
| Moderately Worse |
|
| A Little Worse |
|
| No Change |
|
| A Little Better |
|
| Moderately Better |
|
| A Great Deal Better |
|
| Title | Measurements |
|---|---|
| A Great Deal Worse |
|
| Moderately Worse |
|
| A Little Worse |
|
| No Change |
|
| A Little Better |
|
| Moderately Better |
|
| A Great Deal Better |
|
| Title | Measurements |
|---|---|
| A Great Deal Worse |
|
| Moderately Worse |
|
| A Little Worse |
|
| No Change |
|
| A Little Better |
|
| Moderately Better |
|
| A Great Deal Better |
|
| Moderately Worse |
|
| A Little Worse |
|
| No Change |
|
| A Little Better |
|
| Moderately Better |
|
| A Great Deal Better |
|
| Title | Measurements |
|---|---|
| A Great Deal Worse |
|
| Moderately Worse |
|
| A Little Worse |
|
| No Change |
|
| A Little Better |
|
| Moderately Better |
|
| A Great Deal Better |
|
| Title | Measurements |
|---|---|
| A Great Deal Worse |
|
| Moderately Worse |
|
| A Little Worse |
|
| No Change |
|
| A Little Better |
|
| Moderately Better |
|
| A Great Deal Better |
|
| Moderately Worse |
|
| A Little Worse |
|
| No Change |
|
| A Little Better |
|
| Moderately Better |
|
| A Great Deal Better |
|
| Title | Measurements |
|---|---|
| A Great Deal Worse |
|
| Moderately Worse |
|
| A Little Worse |
|
| No Change |
|
| A Little Better |
|
| Moderately Better |
|
| A Great Deal Better |
|
| Title | Measurements |
|---|---|
| A Great Deal Worse |
|
| Moderately Worse |
|
| A Little Worse |
|
| No Change |
|
| A Little Better |
|
| Moderately Better |
|
| A Great Deal Better |
|
| Moderately Worse |
|
| A Little Worse |
|
| No Change |
|
| A Little Better |
|
| Moderately Better |
|
| A Great Deal Better |
|
| Title | Measurements |
|---|---|
| A Great Deal Worse |
|
| Moderately Worse |
|
| A Little Worse |
|
| No Change |
|
| A Little Better |
|
| Moderately Better |
|
| A Great Deal Better |
|
| Title | Measurements |
|---|---|
| A Great Deal Worse |
|
| Moderately Worse |
|
| A Little Worse |
|
| No Change |
|
| A Little Better |
|
| Moderately Better |
|
| A Great Deal Better |
|
| A Little Worse |
|
| No Change |
|
| A Little Better |
|
| Moderately Better |
|
| A Great Deal Better |
|
| A Little Worse |
|
| No Change |
|
| A Little Better |
|
| Moderately Better |
|
| A Great Deal Better |
|