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

February 29, 2012 updated by: Lumara Health, Inc.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

105

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Coquitlam, British Columbia, Canada, V3K 3P4
        • Gain Medical Centre
      • North Vancouver, British Columbia, Canada, V7M 2H5
        • Stephen Kaye, MD
      • White Rock, British Columbia, Canada, V4B 5C9
        • Southern Healthcare Centre
    • Newfoundland and Labrador
      • Mt. Pearl, Newfoundland and Labrador, Canada, A1N 1W7
        • Common Wealth Medical Clinic
    • Ontario
      • Ottawa, Ontario, Canada, K1V 0Y3
        • The Ottawa Hospital-Soundcare Medical Centre
      • Toronto, Ontario, Canada, M5H 3P5
        • Royal Health Care Centre
      • Windsor, Ontario, Canada, N8X 3V6
        • Windsor Metropolitan Hospital
  • United States
    • Alabama
      • Montgomery, Alabama, United States, 36116
        • Montgomery Women's Health Associates, P.C.
    • Arizona
      • Chandler, Arizona, United States, 85225
        • Star W. Research
      • Phoenix, Arizona, United States, 85032
        • Precision Trials LLC
    • Arkansas
      • Searcy, Arkansas, United States, 72143
        • Searcy Medical Center
    • California
      • Dinuba, California, United States, 93618
        • Universal Biopharma Research Institute, Inc.
      • San Diego, California, United States, 92103
        • San Diego Clinical Research Center
    • Colorado
      • Lakewood, Colorado, United States, 80228
        • Red Rocks OB/Gyn
    • Connecticut
      • Farmington, Connecticut, United States
        • Taylor Associates/Gynecology
    • Florida
      • Clearwater, Florida, United States, 33759
        • Women's Medical Research Group, LLC
      • Hudson, Florida, United States, 34667
        • Clinical Research of Tampa Bay
      • Largo, Florida, United States, 33770
        • Innovative Research of W. Florida
      • Paw Paw, Florida, United States, 49079
        • Women's Health Care Specialists, PC
      • Tampa, Florida, United States, 33607
        • Tampa Bay Women's Healthcare Alliance, LLP
      • West Palm Beach, Florida, United States, 33409
        • Comprehensive Clinical Trials, Llc
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Atlanta Women's Research Institute, Inc.
      • Roswell, Georgia, United States, 30075
        • Atlanta North Gynecology, PC
    • Idaho
      • Boise, Idaho, United States, 83712
        • Womans Clinic
      • Idaho Falls, Idaho, United States, 83404
        • Rosemark Women Care Specialists
    • Illinois
      • Champaign, Illinois, United States, 61820
        • Women's Health Practice, LLC
    • Indiana
      • South Bend, Indiana, United States, 46601
        • Northern Indiana Womens Health Research
    • Michigan
      • Grand Rapids, Michigan, United States, 49506
        • Female Pelvic Medicine and Urogynecology
    • New York
      • Brooklyn, New York, United States, 11219
        • Boro Park ObGyn
    • North Carolina
      • New Bern, North Carolina, United States, 28562
        • Eastern Carolina Womens Center
      • Winston Salem, North Carolina, United States, 27103
        • Lyndhurst Clinical Research
      • Winston-Salem, North Carolina, United States, 27103
        • Winston-Salem Woman Care, PA
    • Ohio
      • Gallipolis, Ohio, United States, 45631
        • Holzer Clinic
      • Miamisburg, Ohio, United States, 45342
        • HWC Women's Research Center
    • Oregon
      • Medford, Oregon, United States, 97504
        • Advanced Clinical Research
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18105
        • Lehigh Valley Health Network
      • West Reading, Pennsylvania, United States, 19611
        • Advanced Clinical Concepts
    • South Carolina
      • Simpsonville, South Carolina, United States, 29681
        • Hillcrest Clinical Research, LLC
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
        • Southeastern Clinical Research
      • Jackson, Tennessee, United States, 38305
        • The Jackson Clinic, PA
      • Memphis, Tennessee, United States, 38119
        • Women's Care Center, PLC
      • Memphis, Tennessee, United States, 38120
        • Gynecology and Obstetrics, P.C.
    • Texas
      • Austin, Texas, United States, 78705
        • Professional Quality Research/Women Partners
      • Corpus Christi, Texas, United States, 78414
        • Advanced Research Associates
      • Houston, Texas, United States, 77054
        • Woman's Hospital of Texas
      • Irving, Texas, United States, 75061
        • Bexar Clinical Trials
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Salt Lake Research
      • Sandy, Utah, United States, 84070
        • Salt Lake Women's Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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)
Time Frame: Baseline -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]
Time Frame: 12 Weeks
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]
Time Frame: 12 weeks
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]
Time Frame: 12 Weeks
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]
Time Frame: 12 Weeks
12 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lumara Health, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

December 26, 2007

First Submitted That Met QC Criteria

January 9, 2008

First Posted (Estimate)

January 10, 2008

Study Record Updates

Last Update Posted (Estimate)

March 2, 2012

Last Update Submitted That Met QC Criteria

February 29, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LDC-201-601-669020

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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