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

Lumara Health, Inc.48 sites in 2 countries105 target enrollmentOctober 2007

ConditionsVulvodynia

Interventionsplacebo lidocaine Lidocaine/Diphenhydramine

DrugsLidocaine/Diphenhydramine lidocaine placebo

Overview

Phase: Phase 2
Intervention: placebo
Conditions: Vulvodynia
Sponsor: Lumara Health, Inc.
Enrollment: 105
Locations: 48
Primary Endpoint: Mean Marinoff Dyspareunia Scale Score (MDSS) at End of Treatment (12 Weeks)
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 2007

End Date

July 2009

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Lumara Health, Inc.

Responsible Party

Sponsor

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.

Arms & Interventions

3 (Placebo)

Intervention: placebo

1 (Lidocaine)

Intervention: lidocaine

2 (Lidocaine/Diphenhydramine)

Intervention: Lidocaine/Diphenhydramine

Outcomes

Primary Outcomes

Mean Marinoff Dyspareunia Scale Score (MDSS) at End of Treatment (12 Weeks)

Time Frame: 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 Outcomes

Change From Baseline in Marinoff Dyspareunia Scale Score at End of Treatment (12 Weeks)(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)