Phase 2
N=105
Safety and Efficacy of Two Vaginal Products Versus Placebo in Patients With Vaginal Discomfort
Vulvodynia
Bottom Line
View on ClinicalTrials.gov: NCT00590590 ↗Enrolled (actual)
105
Serious AEs
0.0%
Results posted
Feb 2011
Primary outcome: Primary: Mean Marinoff Dyspareunia Scale Score (MDSS) at End of Treatment (12 Weeks) — 1.8; 1.8; 1.7 scores on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Lidocaine/Diphenhydramine (Drug); lidocaine (Drug); placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Lumara Health, Inc.
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Marinoff Dyspareunia Scale Score (MDSS) at End of Treatment (12 Weeks) |
1.8; 1.8; 1.7 | — |
| SECONDARY Change From Baseline in Marinoff Dyspareunia Scale Score at End of Treatment (12 Weeks) |
-0.6; -0.4; -0.7 | — |
| 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] |
-9.9; -3.8; -14.6 | — |
| 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] |
-10.3; -19.6; -19.3 | — |
| 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] |
-10.4; -5.3; -16.3 | — |
| 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] |
-3.0; -1.7; -2.4 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00590590). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.