Safety and Efficacy of Two Vaginal Products Versus Placebo in Patients With Vaginal Discomfort
1 other identifier
interventional
105
2 countries
48
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2007
48 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 26, 2007
CompletedFirst Posted
Study publicly available on registry
January 10, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedResults Posted
Study results publicly available
February 9, 2011
CompletedMarch 2, 2012
February 1, 2012
1.7 years
December 26, 2007
June 30, 2010
February 29, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
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
12 weeks
Secondary Outcomes (5)
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
Study Arms (3)
3 (Placebo)
PLACEBO COMPARATOR1 (Lidocaine)
EXPERIMENTAL2 (Lidocaine/Diphenhydramine)
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Patients must have sought doctor's care for this condition.
- Patients must be having menstrual cycles.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (48)
Montgomery Women's Health Associates, P.C.
Montgomery, Alabama, 36116, United States
Star W. Research
Chandler, Arizona, 85225, United States
Precision Trials LLC
Phoenix, Arizona, 85032, United States
Searcy Medical Center
Searcy, Arkansas, 72143, United States
Universal Biopharma Research Institute, Inc.
Dinuba, California, 93618, United States
San Diego Clinical Research Center
San Diego, California, 92103, United States
Red Rocks OB/GYN
Lakewood, Colorado, 80228, United States
Taylor Associates/Gynecology
Farmington, Connecticut, United States
Women's Medical Research Group, LLC
Clearwater, Florida, 33759, United States
Clinical Research of Tampa Bay
Hudson, Florida, 34667, United States
Innovative Research of W. Florida
Largo, Florida, 33770, United States
Women's Health Care Specialists, PC
Paw Paw, Florida, 49079, United States
Tampa Bay Women's Healthcare Alliance, LLP
Tampa, Florida, 33607, United States
Comprehensive Clinical Trials, LLC
West Palm Beach, Florida, 33409, United States
Atlanta Women's Research Institute, Inc.
Atlanta, Georgia, 30342, United States
Atlanta North Gynecology, PC
Roswell, Georgia, 30075, United States
Womans Clinic
Boise, Idaho, 83712, United States
Rosemark Women Care Specialists
Idaho Falls, Idaho, 83404, United States
Women's Health Practice, LLC
Champaign, Illinois, 61820, United States
Northern Indiana Womens Health Research
South Bend, Indiana, 46601, United States
Female Pelvic Medicine and Urogynecology
Grand Rapids, Michigan, 49506, United States
Boro Park ObGyn
Brooklyn, New York, 11219, United States
Eastern Carolina Womens Center
New Bern, North Carolina, 28562, United States
Lyndhurst Clinical Research
Winston-Salem, North Carolina, 27103, United States
Winston-Salem Woman Care, PA
Winston-Salem, North Carolina, 27103, United States
Holzer Clinic
Gallipolis, Ohio, 45631, United States
HWC Women's Research Center
Miamisburg, Ohio, 45342, United States
Advanced Clinical Research
Medford, Oregon, 97504, United States
Lehigh Valley Health Network
Allentown, Pennsylvania, 18105, United States
Advanced Clinical Concepts
West Reading, Pennsylvania, 19611, United States
Hillcrest Clinical Research, LLC
Simpsonville, South Carolina, 29681, United States
Southeastern Clinical Research
Chattanooga, Tennessee, 37403, United States
The Jackson Clinic, PA
Jackson, Tennessee, 38305, United States
Women's Care Center, PLC
Memphis, Tennessee, 38119, United States
Gynecology and Obstetrics, P.C.
Memphis, Tennessee, 38120, United States
Professional Quality Research/Women Partners
Austin, Texas, 78705, United States
Advanced Research Associates
Corpus Christi, Texas, 78414, United States
Woman's Hospital of Texas
Houston, Texas, 77054, United States
Bexar Clinical Trials
Irving, Texas, 75061, United States
Salt Lake Research
Salt Lake City, Utah, 84107, United States
Salt Lake Women's Center
Sandy City, Utah, 84070, United States
Gain Medical Centre
Coquitlam, British Columbia, V3K 3P4, Canada
Stephen Kaye, MD
North Vancouver, British Columbia, V7M 2H5, Canada
Southern Healthcare Centre
White Rock, British Columbia, V4B 5C9, Canada
Common Wealth Medical Clinic
Mount Pearl, Newfoundland and Labrador, A1N 1W7, Canada
The Ottawa Hospital-Soundcare Medical Centre
Ottawa, Ontario, K1V 0Y3, Canada
Royal Health Care Centre
Toronto, Ontario, M5H 3P5, Canada
Windsor Metropolitan Hospital
Windsor, Ontario, N8X 3V6, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The study was discontinued following enrollment of 106 of the planned 140 participants due to slow recruitment.
Results Point of Contact
- Title
- Jim Joffrion, Sr. Director, Clinical Affairs
- Organization
- KV Pharmaceutical
Study Officials
- STUDY DIRECTOR
Jim Joffrion
Lumara Health, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 26, 2007
First Posted
January 10, 2008
Study Start
October 1, 2007
Primary Completion
June 1, 2009
Study Completion
July 1, 2009
Last Updated
March 2, 2012
Results First Posted
February 9, 2011
Record last verified: 2012-02