Trial Outcomes & Findings for Vestibulodynia: Understanding Pathophysiology and Determining Appropriate Treatments (NCT NCT03844412)
NCT ID: NCT03844412
Last Updated: 2026-03-19
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
209 participants
Primary outcome timeframe
Prior to randomization
Results posted on
2026-03-19
Participant Flow
Participant milestones
| Measure |
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.
|
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
|
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 Moisturel™ cream
|
Placebo
placebo cream and placebo pill
Placebo cream: The comparison treatment will be an identical-appearing placebo Moisturel™ cream
Placebo pill: The comparison treatment will be an identical-appearing placebo pill
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
52
|
52
|
52
|
53
|
|
Overall Study
COMPLETED
|
40
|
34
|
47
|
45
|
|
Overall Study
NOT COMPLETED
|
12
|
18
|
5
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Vestibulodynia: Understanding Pathophysiology and Determining Appropriate Treatments
Baseline characteristics by cohort
| Measure |
Combined Peripheral and Central Treatments
n=52 Participants
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.
|
Peripheral Treatment
n=52 Participants
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
|
Central Treatment
n=52 Participants
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 Moisturel™ cream
|
Placebo
n=53 Participants
placebo cream and placebo pill
Placebo cream: The comparison treatment will be an identical-appearing placebo Moisturel™ cream
Placebo pill: The comparison treatment will be an identical-appearing placebo pill
|
Total
n=209 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
27.2 years
STANDARD_DEVIATION 7.61 • n=110 Participants
|
27.7 years
STANDARD_DEVIATION 7.74 • n=114 Participants
|
26.5 years
STANDARD_DEVIATION 6.92 • n=224 Participants
|
24.7 years
STANDARD_DEVIATION 6.48 • n=104 Participants
|
26.5 years
STANDARD_DEVIATION 7.24 • n=2 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=110 Participants
|
52 Participants
n=114 Participants
|
52 Participants
n=224 Participants
|
53 Participants
n=104 Participants
|
209 Participants
n=2 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=224 Participants
|
0 Participants
n=104 Participants
|
0 Participants
n=2 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=110 Participants
|
7 Participants
n=114 Participants
|
7 Participants
n=224 Participants
|
7 Participants
n=104 Participants
|
27 Participants
n=2 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
46 Participants
n=110 Participants
|
45 Participants
n=114 Participants
|
45 Participants
n=224 Participants
|
46 Participants
n=104 Participants
|
182 Participants
n=2 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=224 Participants
|
0 Participants
n=104 Participants
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=224 Participants
|
0 Participants
n=104 Participants
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=110 Participants
|
6 Participants
n=114 Participants
|
10 Participants
n=224 Participants
|
8 Participants
n=104 Participants
|
33 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=224 Participants
|
0 Participants
n=104 Participants
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=110 Participants
|
2 Participants
n=114 Participants
|
6 Participants
n=224 Participants
|
3 Participants
n=104 Participants
|
17 Participants
n=2 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=110 Participants
|
36 Participants
n=114 Participants
|
29 Participants
n=224 Participants
|
38 Participants
n=104 Participants
|
136 Participants
n=2 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=110 Participants
|
8 Participants
n=114 Participants
|
7 Participants
n=224 Participants
|
4 Participants
n=104 Participants
|
23 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=224 Participants
|
0 Participants
n=104 Participants
|
0 Participants
n=2 Participants
|
|
Region of Enrollment
United States
|
52 Participants
n=110 Participants
|
52 Participants
n=114 Participants
|
52 Participants
n=224 Participants
|
53 Participants
n=104 Participants
|
209 Participants
n=2 Participants
|
|
Vestibulodynia Subtype
Central
|
38 Participants
n=110 Participants
|
33 Participants
n=114 Participants
|
37 Participants
n=224 Participants
|
33 Participants
n=104 Participants
|
141 Participants
n=2 Participants
|
|
Vestibulodynia Subtype
Peripheral
|
14 Participants
n=110 Participants
|
19 Participants
n=114 Participants
|
15 Participants
n=224 Participants
|
20 Participants
n=104 Participants
|
68 Participants
n=2 Participants
|
PRIMARY outcome
Timeframe: Baseline, 16 weeksPopulation: Participants with data at both time points are included.
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.
Outcome measures
| Measure |
Combined Peripheral and Central Treatments
n=42 Participants
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.
|
Peripheral Treatment
n=38 Participants
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
|
Central Treatment
n=45 Participants
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 Moisturel™ cream
|
Placebo
n=45 Participants
placebo cream and placebo pill
Placebo cream: The comparison treatment will be an identical-appearing placebo Moisturel™ cream
Placebo pill: The comparison treatment will be an identical-appearing placebo pill
|
|---|---|---|---|---|
|
Pain Score During the Tampon Test
Baseline
|
4.37 score on a scale
Standard Error 0.30
|
3.75 score on a scale
Standard Error 0.29
|
4.04 score on a scale
Standard Error 0.36
|
4.36 score on a scale
Standard Error 0.25
|
|
Pain Score During the Tampon Test
16 weeks
|
3.02 score on a scale
Standard Error 0.33
|
2.66 score on a scale
Standard Error 0.36
|
3.22 score on a scale
Standard Error 0.41
|
3.64 score on a scale
Standard Error 0.39
|
PRIMARY outcome
Timeframe: Baseline, 16 weeksPopulation: Participants with data collected at both timepoints.
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.
Outcome measures
| Measure |
Combined Peripheral and Central Treatments
n=42 Participants
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.
|
Peripheral Treatment
n=38 Participants
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
|
Central Treatment
n=45 Participants
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 Moisturel™ cream
|
Placebo
n=45 Participants
placebo cream and placebo pill
Placebo cream: The comparison treatment will be an identical-appearing placebo Moisturel™ cream
Placebo pill: The comparison treatment will be an identical-appearing placebo pill
|
|---|---|---|---|---|
|
Change in Self-reported Pain Via the Short Form- McGill Pain Questionnaire (SF-MPQ)
|
-5.17 score on a scale
Standard Error 1.05
|
-5.08 score on a scale
Standard Error 0.97
|
-4.80 score on a scale
Standard Error 0.85
|
-4.60 score on a scale
Standard Error 1.39
|
PRIMARY outcome
Timeframe: Prior to randomizationPopulation: Data was collected prior to randomization. Therefore, data is reported by participant VBD subtype.
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.
Outcome measures
| Measure |
Combined Peripheral and Central Treatments
n=68 Participants
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.
|
Peripheral Treatment
n=141 Participants
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
|
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 Moisturel™ cream
|
Placebo
placebo cream and placebo pill
Placebo cream: The comparison treatment will be an identical-appearing placebo Moisturel™ cream
Placebo pill: The comparison treatment will be an identical-appearing placebo pill
|
|---|---|---|---|---|
|
Self-reported Physical Health Via SF-12 Health Survey (SF12v2)
|
55.05 score on a scale
Standard Error 0.79
|
49.18 score on a scale
Standard Error 0.77
|
—
|
—
|
PRIMARY outcome
Timeframe: Prior to randomizationPopulation: Data was collected prior to randomization. Therefore, data is reported by participant VBD subtype.
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.
Outcome measures
| Measure |
Combined Peripheral and Central Treatments
n=68 Participants
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.
|
Peripheral Treatment
n=141 Participants
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
|
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 Moisturel™ cream
|
Placebo
placebo cream and placebo pill
Placebo cream: The comparison treatment will be an identical-appearing placebo Moisturel™ cream
Placebo pill: The comparison treatment will be an identical-appearing placebo pill
|
|---|---|---|---|---|
|
Self-reported Mental Health Via SF-12 Health Survey (SF12v2)
|
36.93 score on a scale
Standard Error 1.12
|
36.54 score on a scale
Standard Error 0.81
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, 16 weeksPopulation: Participants with data collected at each timepoint.
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.
Outcome measures
| Measure |
Combined Peripheral and Central Treatments
n=40 Participants
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.
|
Peripheral Treatment
n=46 Participants
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
|
Central Treatment
n=43 Participants
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 Moisturel™ cream
|
Placebo
n=39 Participants
placebo cream and placebo pill
Placebo cream: The comparison treatment will be an identical-appearing placebo Moisturel™ cream
Placebo pill: The comparison treatment will be an identical-appearing placebo pill
|
|---|---|---|---|---|
|
Sexual Health Via Patient-Reported Outcomes Measurement Information System (PROMIS)
Week 16
|
44.36 score on a scale
Standard Error 1.22
|
45.64 score on a scale
Standard Error 1.28
|
42.92 score on a scale
Standard Error 1.02
|
43.87 score on a scale
Standard Error 1.06
|
|
Sexual Health Via Patient-Reported Outcomes Measurement Information System (PROMIS)
Baseline
|
40.64 score on a scale
Standard Error 1.06
|
41.22 score on a scale
Standard Error 0.82
|
41.67 score on a scale
Standard Error 1.07
|
41.93 score on a scale
Standard Error 1.07
|
SECONDARY outcome
Timeframe: Baseline, 8 weeks, and 16 weeksPopulation: Participants with data collected at both timepoints for each comparison.
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.
Outcome measures
| Measure |
Combined Peripheral and Central Treatments
n=35 Participants
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.
|
Peripheral Treatment
n=35 Participants
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
|
Central Treatment
n=35 Participants
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 Moisturel™ cream
|
Placebo
n=36 Participants
placebo cream and placebo pill
Placebo cream: The comparison treatment will be an identical-appearing placebo Moisturel™ cream
Placebo pill: The comparison treatment will be an identical-appearing placebo pill
|
|---|---|---|---|---|
|
Change in Pain Level as Measured by Vaginal Vestibule Pressure Pain Intensities (PPI)
Baseline to 16 weeks
|
-2.14 score on a scale
Standard Error 1.06
|
-1.48 score on a scale
Standard Error 1.10
|
-2.33 score on a scale
Standard Error 0.81
|
-3.63 score on a scale
Standard Error 1.03
|
|
Change in Pain Level as Measured by Vaginal Vestibule Pressure Pain Intensities (PPI)
Baseline to 8 weeks
|
-0.37 score on a scale
Standard Error 1.07
|
-2.43 score on a scale
Standard Error 1.11
|
-0.57 score on a scale
Standard Error 0.76
|
-0.67 score on a scale
Standard Error 0.95
|
SECONDARY outcome
Timeframe: Baseline, 16 weeksPopulation: Participants with data collected at both timepoints.
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.
Outcome measures
| Measure |
Combined Peripheral and Central Treatments
n=19 Participants
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.
|
Peripheral Treatment
n=21 Participants
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
|
Central Treatment
n=20 Participants
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 Moisturel™ cream
|
Placebo
n=16 Participants
placebo cream and placebo pill
Placebo cream: The comparison treatment will be an identical-appearing placebo Moisturel™ cream
Placebo pill: The comparison treatment will be an identical-appearing placebo pill
|
|---|---|---|---|---|
|
Change in Levator Muscle Complex Pressure Pain Threshold (PPT)
|
3.16 kPa
Standard Error 7.87
|
-69.57 kPa
Standard Error 51.32
|
0.45 kPa
Standard Error 6.26
|
-5.38 kPa
Standard Error 22.54
|
SECONDARY outcome
Timeframe: Baseline, 8 weeks, and 16 weeksPopulation: Participants with data collected at both timepoints for each comparison.
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.
Outcome measures
| Measure |
Combined Peripheral and Central Treatments
n=34 Participants
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.
|
Peripheral Treatment
n=34 Participants
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
|
Central Treatment
n=34 Participants
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 Moisturel™ cream
|
Placebo
n=33 Participants
placebo cream and placebo pill
Placebo cream: The comparison treatment will be an identical-appearing placebo Moisturel™ cream
Placebo pill: The comparison treatment will be an identical-appearing placebo pill
|
|---|---|---|---|---|
|
Change in Pain Level as Measured by Remote Bodily PPTs
Baseline to week 8
|
0.00 score on a scale
Standard Error 0.99
|
0.21 score on a scale
Standard Error 1.83
|
-1.44 score on a scale
Standard Error 1.37
|
0.28 score on a scale
Standard Error 1.05
|
|
Change in Pain Level as Measured by Remote Bodily PPTs
Baseline to week 16
|
-2.32 score on a scale
Standard Error 0.89
|
-0.35 score on a scale
Standard Error 2.23
|
-0.62 score on a scale
Standard Error 2.11
|
1.00 score on a scale
Standard Error 1.28
|
SECONDARY outcome
Timeframe: Baseline, 8 weeks, and 16 weeksPopulation: Participants with data collected at each timepoint.
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.
Outcome measures
| Measure |
Combined Peripheral and Central Treatments
n=52 Participants
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.
|
Peripheral Treatment
n=52 Participants
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
|
Central Treatment
n=52 Participants
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 Moisturel™ cream
|
Placebo
n=53 Participants
placebo cream and placebo pill
Placebo cream: The comparison treatment will be an identical-appearing placebo Moisturel™ cream
Placebo pill: The comparison treatment will be an identical-appearing placebo pill
|
|---|---|---|---|---|
|
Somatic Awareness Via Pennebaker Index of Limbic Languidness (PILL)
Week 16
|
8.37 score on a scale
Standard Error 4.16
|
5.46 score on a scale
Standard Error 2.45
|
5.59 score on a scale
Standard Error 2.40
|
7.66 score on a scale
Standard Error 3.23
|
|
Somatic Awareness Via Pennebaker Index of Limbic Languidness (PILL)
Baseline
|
45.31 score on a scale
Standard Error 2.79
|
45.63 score on a scale
Standard Error 3.36
|
38.42 score on a scale
Standard Error 2.82
|
42.55 score on a scale
Standard Error 3.07
|
|
Somatic Awareness Via Pennebaker Index of Limbic Languidness (PILL)
Week 8
|
5.88 score on a scale
Standard Error 3.03
|
1.96 score on a scale
Standard Error 1.38
|
2.94 score on a scale
Standard Error 1.78
|
4.75 score on a scale
Standard Error 2.87
|
SECONDARY outcome
Timeframe: Baseline, 8 weeks, 16 weeks, and 24 weeksPopulation: Study team believed data was being collected, but sleep scale was inadvertently not included in the REDCap survey follow-ups.
The sleep scale is a 12-item scale that measures amount of sleep and ease/difficulty of initiating and maintaining sleep.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 8 weeks, 16 weeks, and 24 weeksPopulation: Study team believed data was being collected, but PSS was inadvertently not included in the REDCap survey follow-ups.
The Perceived stress scale (PSS) is a 10-item scale that measures the impact of personal stress on thoughts and feelings.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 8 weeks, 16 weeks, and 24 weeksPopulation: Study team believed data was being collected, but SCL-27 was inadvertently not included in the REDCap survey follow-ups.
Symptom Check List 27 (SCL-27) questionnaire will be used to measure a broad range of psychological symptoms (e.g., anxiety and depression).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 16 weeksCytokine expression levels will be measured via mesoscale discovery assays.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 8 weeks and 24 weeksChange in cytokine levels will be measured as described above.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 8 weeks and 24 weeksChange in microRNA levels will be measured as described above.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 16 weeksMicroRNA expression levels will be measured via sequencing read.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 8 weeks, 16 weeks, and 24 weeksPopulation: Participants who reported having headaches at initial assessment and had data collected at each timepoint.
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.
Outcome measures
| Measure |
Combined Peripheral and Central Treatments
n=6 Participants
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.
|
Peripheral Treatment
n=5 Participants
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
|
Central Treatment
n=4 Participants
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 Moisturel™ cream
|
Placebo
n=7 Participants
placebo cream and placebo pill
Placebo cream: The comparison treatment will be an identical-appearing placebo Moisturel™ cream
Placebo pill: The comparison treatment will be an identical-appearing placebo pill
|
|---|---|---|---|---|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Headaches
Week 16 to Week 24 · No Change
|
2 Participants
|
2 Participants
|
3 Participants
|
4 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Headaches
Baseline to Week 8 · A Great Deal Worse
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Headaches
Baseline to Week 8 · Moderately Worse
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Headaches
Baseline to Week 8 · A Little Worse
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Headaches
Baseline to Week 8 · No Change
|
3 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Headaches
Baseline to Week 8 · A Little Better
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Headaches
Baseline to Week 8 · Moderately Better
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Headaches
Baseline to Week 8 · A Great Deal Better
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Headaches
Week 8 to Week 16 · A Great Deal Worse
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Headaches
Week 8 to Week 16 · Moderately Worse
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Headaches
Week 8 to Week 16 · A Little Worse
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Headaches
Week 8 to Week 16 · No Change
|
3 Participants
|
2 Participants
|
3 Participants
|
4 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Headaches
Week 8 to Week 16 · A Little Better
|
1 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Headaches
Week 8 to Week 16 · Moderately Better
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Headaches
Week 8 to Week 16 · A Great Deal Better
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Headaches
Week 16 to Week 24 · A Great Deal Worse
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Headaches
Week 16 to Week 24 · Moderately Worse
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Headaches
Week 16 to Week 24 · A Little Worse
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Headaches
Week 16 to Week 24 · A Little Better
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Headaches
Week 16 to Week 24 · Moderately Better
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Headaches
Week 16 to Week 24 · A Great Deal Better
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 8 weeks, 16 weeks, and 24 weeksPopulation: Participants who reported having widespread pain at initial assessment and had data collected at each timepoint.
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.
Outcome measures
| Measure |
Combined Peripheral and Central Treatments
n=21 Participants
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.
|
Peripheral Treatment
n=15 Participants
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
|
Central Treatment
n=16 Participants
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 Moisturel™ cream
|
Placebo
n=14 Participants
placebo cream and placebo pill
Placebo cream: The comparison treatment will be an identical-appearing placebo Moisturel™ cream
Placebo pill: The comparison treatment will be an identical-appearing placebo pill
|
|---|---|---|---|---|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Widespread Pain
Week 8 to Week 16 · A Little Worse
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Widespread Pain
Week 8 to Week 16 · No Change
|
6 Participants
|
3 Participants
|
7 Participants
|
4 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Widespread Pain
Week 8 to Week 16 · Moderately Better
|
4 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Widespread Pain
Week 16 to Week 24 · A Little Worse
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Widespread Pain
Baseline to Week 8 · A Great Deal Worse
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Widespread Pain
Baseline to Week 8 · Moderately Worse
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Widespread Pain
Baseline to Week 8 · A Little Worse
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Widespread Pain
Baseline to Week 8 · No Change
|
8 Participants
|
7 Participants
|
10 Participants
|
9 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Widespread Pain
Baseline to Week 8 · A Little Better
|
6 Participants
|
5 Participants
|
3 Participants
|
2 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Widespread Pain
Baseline to Week 8 · Moderately Better
|
5 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Widespread Pain
Baseline to Week 8 · A Great Deal Better
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Widespread Pain
Week 8 to Week 16 · A Great Deal Worse
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Widespread Pain
Week 8 to Week 16 · Moderately Worse
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Widespread Pain
Week 8 to Week 16 · A Little Better
|
4 Participants
|
6 Participants
|
4 Participants
|
4 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Widespread Pain
Week 8 to Week 16 · A Great Deal Better
|
3 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Widespread Pain
Week 16 to Week 24 · A Great Deal Worse
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Widespread Pain
Week 16 to Week 24 · Moderately Worse
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Widespread Pain
Week 16 to Week 24 · No Change
|
7 Participants
|
4 Participants
|
8 Participants
|
8 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Widespread Pain
Week 16 to Week 24 · A Little Better
|
4 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Widespread Pain
Week 16 to Week 24 · Moderately Better
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Widespread Pain
Week 16 to Week 24 · A Great Deal Better
|
3 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 8 weeks, 16 weeks, and 24 weeksPopulation: Participants who reported having orofacial pain at initial assessment and had data collected at each timepoint.
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.
Outcome measures
| Measure |
Combined Peripheral and Central Treatments
n=7 Participants
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.
|
Peripheral Treatment
n=3 Participants
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
|
Central Treatment
n=7 Participants
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 Moisturel™ cream
|
Placebo
n=5 Participants
placebo cream and placebo pill
Placebo cream: The comparison treatment will be an identical-appearing placebo Moisturel™ cream
Placebo pill: The comparison treatment will be an identical-appearing placebo pill
|
|---|---|---|---|---|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Orofacial Pain
Baseline to Week 8 · A Great Deal Worse
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Orofacial Pain
Baseline to Week 8 · Moderately Worse
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Orofacial Pain
Baseline to Week 8 · A Little Worse
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Orofacial Pain
Baseline to Week 8 · No Change
|
1 Participants
|
3 Participants
|
5 Participants
|
4 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Orofacial Pain
Baseline to Week 8 · A Little Better
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Orofacial Pain
Baseline to Week 8 · Moderately Better
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Orofacial Pain
Baseline to Week 8 · A Great Deal Better
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Orofacial Pain
Week 8 to Week 16 · A Great Deal Worse
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Orofacial Pain
Week 8 to Week 16 · Moderately Worse
|
2 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Orofacial Pain
Week 8 to Week 16 · A Little Worse
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Orofacial Pain
Week 8 to Week 16 · No Change
|
3 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Orofacial Pain
Week 8 to Week 16 · A Little Better
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Orofacial Pain
Week 8 to Week 16 · Moderately Better
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Orofacial Pain
Week 8 to Week 16 · A Great Deal Better
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Orofacial Pain
Week 16 to Week 24 · A Great Deal Worse
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Orofacial Pain
Week 16 to Week 24 · Moderately Worse
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Orofacial Pain
Week 16 to Week 24 · A Little Worse
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Orofacial Pain
Week 16 to Week 24 · No Change
|
3 Participants
|
1 Participants
|
4 Participants
|
2 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Orofacial Pain
Week 16 to Week 24 · A Little Better
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Orofacial Pain
Week 16 to Week 24 · Moderately Better
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Orofacial Pain
Week 16 to Week 24 · A Great Deal Better
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 8 weeks, 16 weeks, and 24 weeksPopulation: Participants who reported having back pain at initial assessment and had data collected at each timepoint.
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.
Outcome measures
| Measure |
Combined Peripheral and Central Treatments
n=8 Participants
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.
|
Peripheral Treatment
n=12 Participants
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
|
Central Treatment
n=12 Participants
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 Moisturel™ cream
|
Placebo
n=9 Participants
placebo cream and placebo pill
Placebo cream: The comparison treatment will be an identical-appearing placebo Moisturel™ cream
Placebo pill: The comparison treatment will be an identical-appearing placebo pill
|
|---|---|---|---|---|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Back Pain
Week 16 to Week 24 · Moderately Worse
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Back Pain
Baseline to Week 8 · A Great Deal Better
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Back Pain
Baseline to Week 8 · Moderately Better
|
1 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Back Pain
Week 8 to Week 16 · A Great Deal Worse
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Back Pain
Week 8 to Week 16 · Moderately Worse
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Back Pain
Week 8 to Week 16 · A Little Worse
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Back Pain
Week 8 to Week 16 · No Change
|
3 Participants
|
4 Participants
|
6 Participants
|
7 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Back Pain
Week 8 to Week 16 · A Little Better
|
3 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Back Pain
Week 8 to Week 16 · Moderately Better
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Back Pain
Week 8 to Week 16 · A Great Deal Better
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Back Pain
Week 16 to Week 24 · A Great Deal Worse
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Back Pain
Week 16 to Week 24 · A Little Worse
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Back Pain
Week 16 to Week 24 · No Change
|
4 Participants
|
3 Participants
|
2 Participants
|
6 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Back Pain
Week 16 to Week 24 · A Little Better
|
1 Participants
|
2 Participants
|
4 Participants
|
0 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Back Pain
Week 16 to Week 24 · Moderately Better
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Back Pain
Week 16 to Week 24 · A Great Deal Better
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Back Pain
Baseline to Week 8 · A Great Deal Worse
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Back Pain
Baseline to Week 8 · Moderately Worse
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Back Pain
Baseline to Week 8 · A Little Worse
|
4 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Back Pain
Baseline to Week 8 · No Change
|
2 Participants
|
3 Participants
|
6 Participants
|
8 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Back Pain
Baseline to Week 8 · A Little Better
|
1 Participants
|
6 Participants
|
1 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 8 weeks, 16 weeks, and 24 weeksPopulation: Participants who reported having abdominal pain at initial assessment and had data collected at each timepoint.
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.
Outcome measures
| Measure |
Combined Peripheral and Central Treatments
n=9 Participants
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.
|
Peripheral Treatment
n=6 Participants
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
|
Central Treatment
n=9 Participants
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 Moisturel™ cream
|
Placebo
n=7 Participants
placebo cream and placebo pill
Placebo cream: The comparison treatment will be an identical-appearing placebo Moisturel™ cream
Placebo pill: The comparison treatment will be an identical-appearing placebo pill
|
|---|---|---|---|---|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Abdominal Pain
Week 8 to Week 16 · A Great Deal Better
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Abdominal Pain
Week 16 to Week 24 · A Great Deal Worse
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Abdominal Pain
Baseline to Week 8 · A Great Deal Worse
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Abdominal Pain
Baseline to Week 8 · Moderately Worse
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Abdominal Pain
Baseline to Week 8 · A Little Worse
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Abdominal Pain
Baseline to Week 8 · No Change
|
2 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Abdominal Pain
Baseline to Week 8 · A Little Better
|
4 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Abdominal Pain
Baseline to Week 8 · Moderately Better
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Abdominal Pain
Baseline to Week 8 · A Great Deal Better
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Abdominal Pain
Week 8 to Week 16 · A Great Deal Worse
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Abdominal Pain
Week 16 to Week 24 · Moderately Worse
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Abdominal Pain
Week 16 to Week 24 · A Little Worse
|
2 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Abdominal Pain
Week 8 to Week 16 · Moderately Worse
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Abdominal Pain
Week 8 to Week 16 · A Little Worse
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Abdominal Pain
Week 8 to Week 16 · No Change
|
3 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Abdominal Pain
Week 8 to Week 16 · A Little Better
|
3 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Abdominal Pain
Week 8 to Week 16 · Moderately Better
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Abdominal Pain
Week 16 to Week 24 · No Change
|
2 Participants
|
2 Participants
|
2 Participants
|
5 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Abdominal Pain
Week 16 to Week 24 · A Little Better
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Abdominal Pain
Week 16 to Week 24 · Moderately Better
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Abdominal Pain
Week 16 to Week 24 · A Great Deal Better
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 8 weeks, 16 weeks, and 24 weeksPopulation: Participants who reported having bladder pain at initial assessment and had data collected at each timepoint.
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.
Outcome measures
| Measure |
Combined Peripheral and Central Treatments
n=4 Participants
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.
|
Peripheral Treatment
n=2 Participants
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
|
Central Treatment
n=5 Participants
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 Moisturel™ cream
|
Placebo
n=3 Participants
placebo cream and placebo pill
Placebo cream: The comparison treatment will be an identical-appearing placebo Moisturel™ cream
Placebo pill: The comparison treatment will be an identical-appearing placebo pill
|
|---|---|---|---|---|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Bladder Pain
Baseline to Week 8 · A Great Deal Worse
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Bladder Pain
Baseline to Week 8 · Moderately Worse
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Bladder Pain
Baseline to Week 8 · A Little Worse
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Bladder Pain
Baseline to Week 8 · No Change
|
2 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Bladder Pain
Baseline to Week 8 · A Little Better
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Bladder Pain
Baseline to Week 8 · Moderately Better
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Bladder Pain
Baseline to Week 8 · A Great Deal Better
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Bladder Pain
Week 8 to Week 16 · A Great Deal Worse
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Bladder Pain
Week 8 to Week 16 · Moderately Worse
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Bladder Pain
Week 8 to Week 16 · A Little Worse
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Bladder Pain
Week 8 to Week 16 · No Change
|
2 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Bladder Pain
Week 8 to Week 16 · A Little Better
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Bladder Pain
Week 8 to Week 16 · Moderately Better
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Bladder Pain
Week 8 to Week 16 · A Great Deal Better
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Bladder Pain
Week 16 to Week 24 · A Great Deal Worse
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Bladder Pain
Week 16 to Week 24 · Moderately Worse
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Bladder Pain
Week 16 to Week 24 · A Little Worse
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Bladder Pain
Week 16 to Week 24 · No Change
|
1 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Bladder Pain
Week 16 to Week 24 · A Little Better
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Bladder Pain
Week 16 to Week 24 · Moderately Better
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Bladder Pain
Week 16 to Week 24 · A Great Deal Better
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 8 weeks, 16 weeks, and 24 weeksPopulation: Participants who reported having menstrual pain at initial assessment and had data collected at each timepoint.
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.
Outcome measures
| Measure |
Combined Peripheral and Central Treatments
n=15 Participants
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.
|
Peripheral Treatment
n=8 Participants
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
|
Central Treatment
n=11 Participants
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 Moisturel™ cream
|
Placebo
n=14 Participants
placebo cream and placebo pill
Placebo cream: The comparison treatment will be an identical-appearing placebo Moisturel™ cream
Placebo pill: The comparison treatment will be an identical-appearing placebo pill
|
|---|---|---|---|---|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Menstrual Pain
Week 16 to Week 24 · A Great Deal Better
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Menstrual Pain
Week 8 to Week 16 · A Little Better
|
1 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Menstrual Pain
Week 8 to Week 16 · Moderately Better
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Menstrual Pain
Week 8 to Week 16 · A Great Deal Better
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Menstrual Pain
Week 16 to Week 24 · A Great Deal Worse
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Menstrual Pain
Week 16 to Week 24 · Moderately Worse
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Menstrual Pain
Week 16 to Week 24 · A Little Worse
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Menstrual Pain
Week 16 to Week 24 · No Change
|
9 Participants
|
4 Participants
|
6 Participants
|
8 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Menstrual Pain
Week 16 to Week 24 · A Little Better
|
2 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Menstrual Pain
Week 16 to Week 24 · Moderately Better
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Menstrual Pain
Baseline to Week 8 · A Great Deal Worse
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Menstrual Pain
Baseline to Week 8 · Moderately Worse
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Menstrual Pain
Baseline to Week 8 · A Little Worse
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Menstrual Pain
Baseline to Week 8 · No Change
|
7 Participants
|
5 Participants
|
5 Participants
|
11 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Menstrual Pain
Baseline to Week 8 · A Little Better
|
4 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Menstrual Pain
Baseline to Week 8 · Moderately Better
|
3 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Menstrual Pain
Baseline to Week 8 · A Great Deal Better
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Menstrual Pain
Week 8 to Week 16 · A Great Deal Worse
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Menstrual Pain
Week 8 to Week 16 · Moderately Worse
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Menstrual Pain
Week 8 to Week 16 · A Little Worse
|
4 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Menstrual Pain
Week 8 to Week 16 · No Change
|
7 Participants
|
4 Participants
|
5 Participants
|
8 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 8 weeks, 16 weeks, and 24 weeksPopulation: Participants who reported having fatigue at initial assessment and had data collected at each timepoint.
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.
Outcome measures
| Measure |
Combined Peripheral and Central Treatments
n=1 Participants
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.
|
Peripheral Treatment
n=2 Participants
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
|
Central Treatment
n=1 Participants
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 Moisturel™ cream
|
Placebo
placebo cream and placebo pill
Placebo cream: The comparison treatment will be an identical-appearing placebo Moisturel™ cream
Placebo pill: The comparison treatment will be an identical-appearing placebo pill
|
|---|---|---|---|---|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Fatigue
Baseline to Week 8 · Moderately Better
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Fatigue
Week 8 to Week 16 · A Little Worse
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Fatigue
Week 16 to Week 24 · A Little Better
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Fatigue
Week 16 to Week 24 · Moderately Better
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Fatigue
Baseline to Week 8 · A Great Deal Worse
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Fatigue
Baseline to Week 8 · Moderately Worse
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Fatigue
Baseline to Week 8 · A Little Worse
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Fatigue
Baseline to Week 8 · No Change
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Fatigue
Baseline to Week 8 · A Little Better
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Fatigue
Baseline to Week 8 · A Great Deal Better
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Fatigue
Week 8 to Week 16 · A Great Deal Worse
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Fatigue
Week 8 to Week 16 · Moderately Worse
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Fatigue
Week 8 to Week 16 · No Change
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Fatigue
Week 8 to Week 16 · A Little Better
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Fatigue
Week 8 to Week 16 · Moderately Better
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Fatigue
Week 8 to Week 16 · A Great Deal Better
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Fatigue
Week 16 to Week 24 · A Great Deal Worse
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Fatigue
Week 16 to Week 24 · Moderately Worse
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Fatigue
Week 16 to Week 24 · A Little Worse
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Fatigue
Week 16 to Week 24 · No Change
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Change in Degree of Overlapping Pain, as Measured by COPC (Chronic Overlapping Pain Condition) Survey - Fatigue
Week 16 to Week 24 · A Great Deal Better
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
Adverse Events
Combined Peripheral and Central Treatments
Serious events: 1 serious events
Other events: 32 other events
Deaths: 0 deaths
Peripheral Treatment
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Central Treatment
Serious events: 1 serious events
Other events: 33 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Combined Peripheral and Central Treatments
n=52 participants at risk
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.
|
Peripheral Treatment
n=52 participants at risk
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
|
Central Treatment
n=52 participants at risk
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 Moisturel™ cream
|
Placebo
n=53 participants at risk
placebo cream and placebo pill
Placebo cream: The comparison treatment will be an identical-appearing placebo Moisturel™ cream
Placebo pill: The comparison treatment will be an identical-appearing placebo pill
|
|---|---|---|---|---|
|
Nervous system disorders
Seizure
|
0.00%
0/52 • 24 weeks
|
0.00%
0/52 • 24 weeks
|
1.9%
1/52 • 24 weeks
|
0.00%
0/53 • 24 weeks
|
|
Endocrine disorders
Severe Acute Pancreatitis
|
1.9%
1/52 • 24 weeks
|
0.00%
0/52 • 24 weeks
|
0.00%
0/52 • 24 weeks
|
0.00%
0/53 • 24 weeks
|
Other adverse events
| Measure |
Combined Peripheral and Central Treatments
n=52 participants at risk
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.
|
Peripheral Treatment
n=52 participants at risk
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
|
Central Treatment
n=52 participants at risk
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 Moisturel™ cream
|
Placebo
n=53 participants at risk
placebo cream and placebo pill
Placebo cream: The comparison treatment will be an identical-appearing placebo Moisturel™ cream
Placebo pill: The comparison treatment will be an identical-appearing placebo pill
|
|---|---|---|---|---|
|
Psychiatric disorders
Anxiety
|
3.8%
2/52 • 24 weeks
|
3.8%
2/52 • 24 weeks
|
5.8%
3/52 • 24 weeks
|
3.8%
2/53 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Hives
|
1.9%
1/52 • 24 weeks
|
0.00%
0/52 • 24 weeks
|
0.00%
0/52 • 24 weeks
|
0.00%
0/53 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/52 • 24 weeks
|
1.9%
1/52 • 24 weeks
|
0.00%
0/52 • 24 weeks
|
0.00%
0/53 • 24 weeks
|
|
Renal and urinary disorders
Difficulty Urinating
|
0.00%
0/52 • 24 weeks
|
0.00%
0/52 • 24 weeks
|
0.00%
0/52 • 24 weeks
|
0.00%
0/53 • 24 weeks
|
|
Gastrointestinal disorders
Constipation
|
13.5%
7/52 • 24 weeks
|
1.9%
1/52 • 24 weeks
|
21.2%
11/52 • 24 weeks
|
1.9%
1/53 • 24 weeks
|
|
Eye disorders
Vision Changes
|
0.00%
0/52 • 24 weeks
|
1.9%
1/52 • 24 weeks
|
0.00%
0/52 • 24 weeks
|
0.00%
0/53 • 24 weeks
|
|
Reproductive system and breast disorders
Breast Swelling
|
0.00%
0/52 • 24 weeks
|
0.00%
0/52 • 24 weeks
|
0.00%
0/52 • 24 weeks
|
0.00%
0/53 • 24 weeks
|
|
Reproductive system and breast disorders
Decreased Sexual Drive
|
1.9%
1/52 • 24 weeks
|
0.00%
0/52 • 24 weeks
|
0.00%
0/52 • 24 weeks
|
0.00%
0/53 • 24 weeks
|
|
Endocrine disorders
Low Blood Sugar
|
0.00%
0/52 • 24 weeks
|
0.00%
0/52 • 24 weeks
|
0.00%
0/52 • 24 weeks
|
0.00%
0/53 • 24 weeks
|
|
Endocrine disorders
High Blood Sugar
|
0.00%
0/52 • 24 weeks
|
0.00%
0/52 • 24 weeks
|
0.00%
0/52 • 24 weeks
|
0.00%
0/53 • 24 weeks
|
|
Cardiac disorders
Increased Heart Rate
|
5.8%
3/52 • 24 weeks
|
0.00%
0/52 • 24 weeks
|
7.7%
4/52 • 24 weeks
|
0.00%
0/53 • 24 weeks
|
|
Cardiac disorders
Irregular Heart Beat
|
1.9%
1/52 • 24 weeks
|
0.00%
0/52 • 24 weeks
|
3.8%
2/52 • 24 weeks
|
0.00%
0/53 • 24 weeks
|
|
Psychiatric disorders
Suicidal Thinking
|
0.00%
0/52 • 24 weeks
|
1.9%
1/52 • 24 weeks
|
0.00%
0/52 • 24 weeks
|
0.00%
0/53 • 24 weeks
|
|
Psychiatric disorders
Mania
|
0.00%
0/52 • 24 weeks
|
0.00%
0/52 • 24 weeks
|
0.00%
0/52 • 24 weeks
|
0.00%
0/53 • 24 weeks
|
|
Psychiatric disorders
Agitation
|
0.00%
0/52 • 24 weeks
|
1.9%
1/52 • 24 weeks
|
3.8%
2/52 • 24 weeks
|
1.9%
1/53 • 24 weeks
|
|
Psychiatric disorders
Hallucinations
|
0.00%
0/52 • 24 weeks
|
0.00%
0/52 • 24 weeks
|
0.00%
0/52 • 24 weeks
|
0.00%
0/53 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle Rigidity
|
0.00%
0/52 • 24 weeks
|
1.9%
1/52 • 24 weeks
|
0.00%
0/52 • 24 weeks
|
0.00%
0/53 • 24 weeks
|
|
Nervous system disorders
Seizures
|
0.00%
0/52 • 24 weeks
|
0.00%
0/52 • 24 weeks
|
1.9%
1/52 • 24 weeks
|
0.00%
0/53 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.00%
0/52 • 24 weeks
|
0.00%
0/52 • 24 weeks
|
1.9%
1/52 • 24 weeks
|
0.00%
0/53 • 24 weeks
|
|
General disorders
Dizziness
|
7.7%
4/52 • 24 weeks
|
1.9%
1/52 • 24 weeks
|
0.00%
0/52 • 24 weeks
|
5.7%
3/53 • 24 weeks
|
|
Nervous system disorders
Serotonergic Symptoms
|
3.8%
2/52 • 24 weeks
|
3.8%
2/52 • 24 weeks
|
1.9%
1/52 • 24 weeks
|
0.00%
0/53 • 24 weeks
|
|
General disorders
Headaches
|
5.8%
3/52 • 24 weeks
|
3.8%
2/52 • 24 weeks
|
7.7%
4/52 • 24 weeks
|
9.4%
5/53 • 24 weeks
|
|
Nervous system disorders
Sensations of Cold Temperatures at the Site
|
0.00%
0/52 • 24 weeks
|
0.00%
0/52 • 24 weeks
|
0.00%
0/52 • 24 weeks
|
0.00%
0/53 • 24 weeks
|
|
Nervous system disorders
Numbness at the Site as Medication is Applied
|
0.00%
0/52 • 24 weeks
|
0.00%
0/52 • 24 weeks
|
0.00%
0/52 • 24 weeks
|
0.00%
0/53 • 24 weeks
|
|
General disorders
Confusion
|
0.00%
0/52 • 24 weeks
|
0.00%
0/52 • 24 weeks
|
1.9%
1/52 • 24 weeks
|
0.00%
0/53 • 24 weeks
|
|
General disorders
Other
|
38.5%
20/52 • 24 weeks
|
23.1%
12/52 • 24 weeks
|
36.5%
19/52 • 24 weeks
|
26.4%
14/53 • 24 weeks
|
|
General disorders
Swelling
|
0.00%
0/52 • 24 weeks
|
0.00%
0/52 • 24 weeks
|
0.00%
0/52 • 24 weeks
|
0.00%
0/53 • 24 weeks
|
|
General disorders
Burning
|
1.9%
1/52 • 24 weeks
|
3.8%
2/52 • 24 weeks
|
0.00%
0/52 • 24 weeks
|
5.7%
3/53 • 24 weeks
|
|
General disorders
Blistering
|
0.00%
0/52 • 24 weeks
|
0.00%
0/52 • 24 weeks
|
0.00%
0/52 • 24 weeks
|
0.00%
0/53 • 24 weeks
|
|
General disorders
Drowsiness
|
9.6%
5/52 • 24 weeks
|
7.7%
4/52 • 24 weeks
|
19.2%
10/52 • 24 weeks
|
7.5%
4/53 • 24 weeks
|
|
General disorders
Insomnia
|
0.00%
0/52 • 24 weeks
|
1.9%
1/52 • 24 weeks
|
3.8%
2/52 • 24 weeks
|
1.9%
1/53 • 24 weeks
|
|
General disorders
Cloudy Thinking
|
1.9%
1/52 • 24 weeks
|
0.00%
0/52 • 24 weeks
|
1.9%
1/52 • 24 weeks
|
1.9%
1/53 • 24 weeks
|
|
General disorders
Dry Mouth
|
7.7%
4/52 • 24 weeks
|
3.8%
2/52 • 24 weeks
|
5.8%
3/52 • 24 weeks
|
7.5%
4/53 • 24 weeks
|
|
Gastrointestinal disorders
Nausea
|
5.8%
3/52 • 24 weeks
|
7.7%
4/52 • 24 weeks
|
3.8%
2/52 • 24 weeks
|
3.8%
2/53 • 24 weeks
|
|
Gastrointestinal disorders
Vomiting
|
1.9%
1/52 • 24 weeks
|
0.00%
0/52 • 24 weeks
|
0.00%
0/52 • 24 weeks
|
0.00%
0/53 • 24 weeks
|
|
Gastrointestinal disorders
Loss of Appetite
|
0.00%
0/52 • 24 weeks
|
0.00%
0/52 • 24 weeks
|
0.00%
0/52 • 24 weeks
|
0.00%
0/53 • 24 weeks
|
|
General disorders
Weight Gain
|
1.9%
1/52 • 24 weeks
|
0.00%
0/52 • 24 weeks
|
7.7%
4/52 • 24 weeks
|
0.00%
0/53 • 24 weeks
|
|
General disorders
Weight Loss
|
0.00%
0/52 • 24 weeks
|
0.00%
0/52 • 24 weeks
|
0.00%
0/52 • 24 weeks
|
0.00%
0/53 • 24 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place