Safety and Efficacy of Two Vaginal Products Versus Placebo in Patients With Vaginal Discomfort

Study Overview
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Brief Summary
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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.

Conditions
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Vulvodynia

Intervention / Treatment
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* Drug: Lidocaine/Diphenhydramine
* Drug: lidocaine
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 3 (Placebo)<br> | Drug: placebo<br>* semi solid, twice weekly for 4 months<br>|
| Experimental: 1 (Lidocaine)<br> | Drug: lidocaine<br>* semi solid, twice weekly for 4 months<br>|
| Experimental: 2 (Lidocaine/Diphenhydramine)<br> | Drug: Lidocaine/Diphenhydramine<br>* semi solid, twice weekly, 4 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline -12 Weeks | 
| 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 |