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

NCT00590590 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2012-03-02

Study results available
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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.

Conditions

  • Vulvodynia

Interventions

DRUG

Lidocaine/Diphenhydramine

semi solid, twice weekly, 4 months

DRUG

lidocaine

semi solid, twice weekly for 4 months

DRUG

placebo

semi solid, twice weekly for 4 months

Sponsors & Collaborators

  • Lumara Health, Inc.

    lead INDUSTRY

Principal Investigators

  • Jim Joffrion · Lumara Health, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2009-06-30
Completion
2009-07-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00590590 on ClinicalTrials.gov