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

Primary Purpose

Vulvodynia

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Lidocaine/Diphenhydramine
lidocaine
placebo
Sponsored by
Lumara Health, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vulvodynia

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Montgomery Women's Health Associates, P.C.
  • Star W. Research
  • Precision Trials LLC
  • Searcy Medical Center
  • Universal Biopharma Research Institute, Inc.
  • San Diego Clinical Research Center
  • Red Rocks OB/GYN
  • Taylor Associates/Gynecology
  • Women's Medical Research Group, LLC
  • Clinical Research of Tampa Bay
  • Innovative Research of W. Florida
  • Women's Health Care Specialists, PC
  • Tampa Bay Women's Healthcare Alliance, LLP
  • Comprehensive Clinical Trials, LLC
  • Atlanta Women's Research Institute, Inc.
  • Atlanta North Gynecology, PC
  • Womans Clinic
  • Rosemark Women Care Specialists
  • Women's Health Practice, LLC
  • Northern Indiana Womens Health Research
  • Female Pelvic Medicine and Urogynecology
  • Boro Park ObGyn
  • Eastern Carolina Womens Center
  • Lyndhurst Clinical Research
  • Winston-Salem Woman Care, PA
  • Holzer Clinic
  • HWC Women's Research Center
  • Advanced Clinical Research
  • Lehigh Valley Health Network
  • Advanced Clinical Concepts
  • Hillcrest Clinical Research, LLC
  • Southeastern Clinical Research
  • The Jackson Clinic, PA
  • Women's Care Center, PLC
  • Gynecology and Obstetrics, P.C.
  • Professional Quality Research/Women Partners
  • Advanced Research Associates
  • Woman's Hospital of Texas
  • Bexar Clinical Trials
  • Salt Lake Research
  • Salt Lake Women's Center
  • Gain Medical Centre
  • Stephen Kaye, MD
  • Southern Healthcare Centre
  • Common Wealth Medical Clinic
  • The Ottawa Hospital-Soundcare Medical Centre
  • Royal Health Care Centre
  • Windsor Metropolitan Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

3 (Placebo)

1 (Lidocaine)

2 (Lidocaine/Diphenhydramine)

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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]
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]
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]
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]

Full Information

First Posted
December 26, 2007
Last Updated
February 29, 2012
Sponsor
Lumara Health, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00590590
Brief Title
Safety and Efficacy of Two Vaginal Products Versus Placebo in Patients With Vaginal Discomfort
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lumara Health, Inc.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vulvodynia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
3 (Placebo)
Arm Type
Placebo Comparator
Arm Title
1 (Lidocaine)
Arm Type
Experimental
Arm Title
2 (Lidocaine/Diphenhydramine)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Lidocaine/Diphenhydramine
Intervention Description
semi solid, twice weekly, 4 months
Intervention Type
Drug
Intervention Name(s)
lidocaine
Intervention Description
semi solid, twice weekly for 4 months
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
semi solid, twice weekly for 4 months
Primary Outcome Measure Information:
Title
Mean Marinoff Dyspareunia Scale Score (MDSS) at End of Treatment (12 Weeks)
Description
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
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change From Baseline in Marinoff Dyspareunia Scale Score at End of Treatment (12 Weeks)
Description
0-3 scale with 0=no dyspareunia and 3= completely prevents intercourse
Time Frame
Baseline -12 Weeks
Title
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
Title
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
Title
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
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jim Joffrion
Organizational Affiliation
Lumara Health, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Montgomery Women's Health Associates, P.C.
City
Montgomery
State/Province
Alabama
ZIP/Postal Code
36116
Country
United States
Facility Name
Star W. Research
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85225
Country
United States
Facility Name
Precision Trials LLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Searcy Medical Center
City
Searcy
State/Province
Arkansas
ZIP/Postal Code
72143
Country
United States
Facility Name
Universal Biopharma Research Institute, Inc.
City
Dinuba
State/Province
California
ZIP/Postal Code
93618
Country
United States
Facility Name
San Diego Clinical Research Center
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Red Rocks OB/GYN
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
Facility Name
Taylor Associates/Gynecology
City
Farmington
State/Province
Connecticut
Country
United States
Facility Name
Women's Medical Research Group, LLC
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33759
Country
United States
Facility Name
Clinical Research of Tampa Bay
City
Hudson
State/Province
Florida
ZIP/Postal Code
34667
Country
United States
Facility Name
Innovative Research of W. Florida
City
Largo
State/Province
Florida
ZIP/Postal Code
33770
Country
United States
Facility Name
Women's Health Care Specialists, PC
City
Paw Paw
State/Province
Florida
ZIP/Postal Code
49079
Country
United States
Facility Name
Tampa Bay Women's Healthcare Alliance, LLP
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Comprehensive Clinical Trials, LLC
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Atlanta Women's Research Institute, Inc.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Atlanta North Gynecology, PC
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30075
Country
United States
Facility Name
Womans Clinic
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712
Country
United States
Facility Name
Rosemark Women Care Specialists
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Women's Health Practice, LLC
City
Champaign
State/Province
Illinois
ZIP/Postal Code
61820
Country
United States
Facility Name
Northern Indiana Womens Health Research
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
Female Pelvic Medicine and Urogynecology
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49506
Country
United States
Facility Name
Boro Park ObGyn
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11219
Country
United States
Facility Name
Eastern Carolina Womens Center
City
New Bern
State/Province
North Carolina
ZIP/Postal Code
28562
Country
United States
Facility Name
Lyndhurst Clinical Research
City
Winston Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Winston-Salem Woman Care, PA
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Holzer Clinic
City
Gallipolis
State/Province
Ohio
ZIP/Postal Code
45631
Country
United States
Facility Name
HWC Women's Research Center
City
Miamisburg
State/Province
Ohio
ZIP/Postal Code
45342
Country
United States
Facility Name
Advanced Clinical Research
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Lehigh Valley Health Network
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18105
Country
United States
Facility Name
Advanced Clinical Concepts
City
West Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611
Country
United States
Facility Name
Hillcrest Clinical Research, LLC
City
Simpsonville
State/Province
South Carolina
ZIP/Postal Code
29681
Country
United States
Facility Name
Southeastern Clinical Research
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
Facility Name
The Jackson Clinic, PA
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Women's Care Center, PLC
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Gynecology and Obstetrics, P.C.
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Professional Quality Research/Women Partners
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Advanced Research Associates
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78414
Country
United States
Facility Name
Woman's Hospital of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
Bexar Clinical Trials
City
Irving
State/Province
Texas
ZIP/Postal Code
75061
Country
United States
Facility Name
Salt Lake Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Salt Lake Women's Center
City
Sandy
State/Province
Utah
ZIP/Postal Code
84070
Country
United States
Facility Name
Gain Medical Centre
City
Coquitlam
State/Province
British Columbia
ZIP/Postal Code
V3K 3P4
Country
Canada
Facility Name
Stephen Kaye, MD
City
North Vancouver
State/Province
British Columbia
ZIP/Postal Code
V7M 2H5
Country
Canada
Facility Name
Southern Healthcare Centre
City
White Rock
State/Province
British Columbia
ZIP/Postal Code
V4B 5C9
Country
Canada
Facility Name
Common Wealth Medical Clinic
City
Mt. Pearl
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1N 1W7
Country
Canada
Facility Name
The Ottawa Hospital-Soundcare Medical Centre
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1V 0Y3
Country
Canada
Facility Name
Royal Health Care Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5H 3P5
Country
Canada
Facility Name
Windsor Metropolitan Hospital
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8X 3V6
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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