Vulvodynia
Conditions
Brief summary
This study will evaluate the efficacy and safety of two vaginal products compared with that of placebo to determine if the two products are better than placebo in the relief of vaginal discomfort.
Interventions
DRUGLidocaine/Diphenhydramine
semi solid, twice weekly, 4 months
DRUGlidocaine
semi solid, twice weekly for 4 months
DRUGplacebo
semi solid, twice weekly for 4 months
Sponsors
Lumara Health, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Patients must have sought doctor's care for this condition. * Patients must be having menstrual cycles.
Exclusion criteria
* Patients must not have any vaginal infections. * Patients must not be pregnant or nursing. * Must not be receiving any other medicinal therapies or any medications that would interfere with the outcome of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Marinoff Dyspareunia Scale Score (MDSS) at End of Treatment (12 Weeks) | 12 weeks | The MDSS consists of a participant rating of their dyspareunia (painful sexual intercourse) on a 0- to 3-point scale. Each numerical value on the scale coincides with a level of pain experienced during sexual intercourse; 0 = no dyspareunia (no pain with intercourse) and 3 = completely prevents intercourse |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Marinoff Dyspareunia Scale Score at End of Treatment (12 Weeks) | Baseline -12 Weeks | 0-3 scale with 0=no dyspareunia and 3= completely prevents intercourse |
| Change From Baseline in Overall Vulvar Vestibulitis Syndrome (VVS)-Related Discomfort Visual Analog Scale (VAS) Score at End of Treatment (12 Weeks) [0 = No Discomfort and 100 = Most Severe Discomfort] | 12 Weeks | — |
| Change From Baseline in Overall Intercourse-Related Pain Visual Analog Scale (VAS) Score at End of Treatment (12 Weeks) [0 = No Pain and 100 = Most Severe Pain] | 12 weeks | — |
| Change From Baseline in Overall Vulvar Vestibulitis Symptoms Visual Analog Scale (VAS) Score at End of Treatment (12 Weeks) [0 = No Symptoms and 100 = As Bad as They Can be] | 12 Weeks | — |
| Change From Baseline in Tenderness (on a 0- to 3-point Scale) on Palpation at End of Treatment (12 Weeks) [Scale Rates the Severity of Pain; 0 =Absent and 3 = Severe] | 12 Weeks | — |
Countries
Canada, United States
Participant flow
Recruitment details
Participants were recruited from 31 physician offices in the US and Canada between 04Sep2007 to 18Mar2009.
Pre-assignment details
Participants will undergo a screening period of two weeks prior to study assignment.
Participants by arm
| Arm | Count |
|---|---|
| Lidocaine/Diphenhydramine (Combination) Lidocaine/Diphenhydramine (Combination) administered twice weekly for 4 months | 39 |
| Lidocaine Lidocaine administered twice weekly for 4 months | 39 |
| Placebo Placebo administered twice weekly for 4 months | 27 |
| Total | 105 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 0 |
| Overall Study | Did not complete due to study closure | 1 | 1 | 1 |
| Overall Study | Did not complete study | 0 | 1 | 0 |
| Overall Study | Lack of Efficacy | 1 | 2 | 0 |
| Overall Study | Lost to Follow-up | 4 | 1 | 2 |
| Overall Study | Protocol Violation | 0 | 0 | 2 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 1 |
Baseline characteristics
| Characteristic | Lidocaine/Diphenhydramine (Combination) | Lidocaine | Placebo | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 39 Participants | 39 Participants | 27 Participants | 105 Participants |
| Age Continuous | 30 years STANDARD_DEVIATION 7.4 | 32 years STANDARD_DEVIATION 9 | 32 years STANDARD_DEVIATION 9.5 | 31 years STANDARD_DEVIATION 8.5 |
| Region of Enrollment Canada | 3 participants | 0 participants | 2 participants | 5 participants |
| Region of Enrollment United States | 36 participants | 39 participants | 25 participants | 100 participants |
| Sex: Female, Male Female | 39 Participants | 39 Participants | 27 Participants | 105 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 30 / 39 | 30 / 39 | 23 / 27 |
| serious Total, serious adverse events | 0 / 39 | 0 / 39 | 0 / 27 |
Outcome results
Primary
Mean Marinoff Dyspareunia Scale Score (MDSS) at End of Treatment (12 Weeks)
The MDSS consists of a participant rating of their dyspareunia (painful sexual intercourse) on a 0- to 3-point scale. Each numerical value on the scale coincides with a level of pain experienced during sexual intercourse; 0 = no dyspareunia (no pain with intercourse) and 3 = completely prevents intercourse
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lidocaine/Diphenhydramine (Combination) | Mean Marinoff Dyspareunia Scale Score (MDSS) at End of Treatment (12 Weeks) | 1.8 scores on a scale | Standard Error 0.12 |
| Lidocaine | Mean Marinoff Dyspareunia Scale Score (MDSS) at End of Treatment (12 Weeks) | 1.8 scores on a scale | Standard Error 0.12 |
| Placebo | Mean Marinoff Dyspareunia Scale Score (MDSS) at End of Treatment (12 Weeks) | 1.7 scores on a scale | Standard Error 0.14 |
Comparison: Ha: Drug 1 \< Drug 2
Comparison: Ha: Drug 1 \< Placebo
Comparison: Ha: Drug 2 \< Placebo
Secondary
Change From Baseline in Marinoff Dyspareunia Scale Score at End of Treatment (12 Weeks)
0-3 scale with 0=no dyspareunia and 3= completely prevents intercourse
Time frame: Baseline -12 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lidocaine/Diphenhydramine (Combination) | Change From Baseline in Marinoff Dyspareunia Scale Score at End of Treatment (12 Weeks) | -0.6 Score | Standard Error 0.15 |
| Lidocaine | Change From Baseline in Marinoff Dyspareunia Scale Score at End of Treatment (12 Weeks) | -0.4 Score | Standard Error 0.13 |
| Placebo | Change From Baseline in Marinoff Dyspareunia Scale Score at End of Treatment (12 Weeks) | -0.7 Score | Standard Error 0.15 |
Comparison: Ha: Drug 1 \< Drug 2
Comparison: Ha: Drug 1 \< Placebo
Comparison: Ha: Drug 2 \< Placebo
Secondary
Change From Baseline in Overall Intercourse-Related Pain Visual Analog Scale (VAS) Score at End of Treatment (12 Weeks) [0 = No Pain and 100 = Most Severe Pain]
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lidocaine/Diphenhydramine (Combination) | Change From Baseline in Overall Intercourse-Related Pain Visual Analog Scale (VAS) Score at End of Treatment (12 Weeks) [0 = No Pain and 100 = Most Severe Pain] | -10.3 Score | Standard Error 5.71 |
| Lidocaine | Change From Baseline in Overall Intercourse-Related Pain Visual Analog Scale (VAS) Score at End of Treatment (12 Weeks) [0 = No Pain and 100 = Most Severe Pain] | -19.6 Score | Standard Error 4.42 |
| Placebo | Change From Baseline in Overall Intercourse-Related Pain Visual Analog Scale (VAS) Score at End of Treatment (12 Weeks) [0 = No Pain and 100 = Most Severe Pain] | -19.3 Score | Standard Error 6.55 |
Comparison: Ha: Drug 1 \< Drug 2
Comparison: Ha: Drug 1 \< Placebo
Comparison: Ha: Drug 2 \< Placebo
Secondary
Change From Baseline in Overall Vulvar Vestibulitis Symptoms Visual Analog Scale (VAS) Score at End of Treatment (12 Weeks) [0 = No Symptoms and 100 = As Bad as They Can be]
Time frame: 12 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lidocaine/Diphenhydramine (Combination) | Change From Baseline in Overall Vulvar Vestibulitis Symptoms Visual Analog Scale (VAS) Score at End of Treatment (12 Weeks) [0 = No Symptoms and 100 = As Bad as They Can be] | -10.4 Score | Standard Error 4.31 |
| Lidocaine | Change From Baseline in Overall Vulvar Vestibulitis Symptoms Visual Analog Scale (VAS) Score at End of Treatment (12 Weeks) [0 = No Symptoms and 100 = As Bad as They Can be] | -5.3 Score | Standard Error 4.47 |
| Placebo | Change From Baseline in Overall Vulvar Vestibulitis Symptoms Visual Analog Scale (VAS) Score at End of Treatment (12 Weeks) [0 = No Symptoms and 100 = As Bad as They Can be] | -16.3 Score | Standard Error 4.22 |
Comparison: Ha: Drug 1 \< Drug 2
Comparison: Ha: Drug 1 \< Placebo
Comparison: Ha: Drug 2 \< Placebo
Secondary
Change From Baseline in Overall Vulvar Vestibulitis Syndrome (VVS)-Related Discomfort Visual Analog Scale (VAS) Score at End of Treatment (12 Weeks) [0 = No Discomfort and 100 = Most Severe Discomfort]
Time frame: 12 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lidocaine/Diphenhydramine (Combination) | Change From Baseline in Overall Vulvar Vestibulitis Syndrome (VVS)-Related Discomfort Visual Analog Scale (VAS) Score at End of Treatment (12 Weeks) [0 = No Discomfort and 100 = Most Severe Discomfort] | -9.9 Score | Standard Error 3.48 |
| Lidocaine | Change From Baseline in Overall Vulvar Vestibulitis Syndrome (VVS)-Related Discomfort Visual Analog Scale (VAS) Score at End of Treatment (12 Weeks) [0 = No Discomfort and 100 = Most Severe Discomfort] | -3.8 Score | Standard Error 4.46 |
| Placebo | Change From Baseline in Overall Vulvar Vestibulitis Syndrome (VVS)-Related Discomfort Visual Analog Scale (VAS) Score at End of Treatment (12 Weeks) [0 = No Discomfort and 100 = Most Severe Discomfort] | -14.6 Score | Standard Error 4.56 |
Comparison: Ha: Drug 1 \< Drug 2
Comparison: Ha: Drug 1 \< Placebo
Comparison: Ha: Drug 2 \< Placebo
Secondary
Change From Baseline in Tenderness (on a 0- to 3-point Scale) on Palpation at End of Treatment (12 Weeks) [Scale Rates the Severity of Pain; 0 =Absent and 3 = Severe]
Time frame: 12 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lidocaine/Diphenhydramine (Combination) | Change From Baseline in Tenderness (on a 0- to 3-point Scale) on Palpation at End of Treatment (12 Weeks) [Scale Rates the Severity of Pain; 0 =Absent and 3 = Severe] | -3.0 Score | Standard Error 0.7 |
| Lidocaine | Change From Baseline in Tenderness (on a 0- to 3-point Scale) on Palpation at End of Treatment (12 Weeks) [Scale Rates the Severity of Pain; 0 =Absent and 3 = Severe] | -1.7 Score | Standard Error 0.67 |
| Placebo | Change From Baseline in Tenderness (on a 0- to 3-point Scale) on Palpation at End of Treatment (12 Weeks) [Scale Rates the Severity of Pain; 0 =Absent and 3 = Severe] | -2.4 Score | Standard Error 0.75 |
Comparison: Ha: Drug 1 \< Drug 2
Comparison: Ha: Drug 1 \< Placebo
Comparison: Ha: Drug 2 \< Placebo