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

Vulvodynia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00590590
• Other study ID #: LDC-201-601-669020
• Status: Completed
• Phase: Phase 2
• First received: December 26, 2007
• Last updated: February 29, 2012
• Start date: October 2007
• Est. completion date: July 2009

Study information

• Verified date: February 2012
• Source: Lumara Health, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: July 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Vulvodynia

Intervention

Drug:
• Lidocaine/Diphenhydramine
semi solid, twice weekly, 4 months
• lidocaine
semi solid, twice weekly for 4 months
• placebo
semi solid, twice weekly for 4 months

Locations

Country	Name	City	State
Canada	Gain Medical Centre	Coquitlam	British Columbia
Canada	Common Wealth Medical Clinic	Mt. Pearl	Newfoundland and Labrador
Canada	Stephen Kaye, MD	North Vancouver	British Columbia
Canada	The Ottawa Hospital-Soundcare Medical Centre	Ottawa	Ontario
Canada	Royal Health Care Centre	Toronto	Ontario
Canada	Southern Healthcare Centre	White Rock	British Columbia
Canada	Windsor Metropolitan Hospital	Windsor	Ontario
United States	Lehigh Valley Health Network	Allentown	Pennsylvania
United States	Atlanta Women's Research Institute, Inc.	Atlanta	Georgia
United States	Professional Quality Research/Women Partners	Austin	Texas
United States	Womans Clinic	Boise	Idaho
United States	Boro Park ObGyn	Brooklyn	New York
United States	Women's Health Practice, LLC	Champaign	Illinois
United States	Star W. Research	Chandler	Arizona
United States	Southeastern Clinical Research	Chattanooga	Tennessee
United States	Women's Medical Research Group, LLC	Clearwater	Florida
United States	Advanced Research Associates	Corpus Christi	Texas
United States	Universal Biopharma Research Institute, Inc.	Dinuba	California
United States	Taylor Associates/Gynecology	Farmington	Connecticut
United States	Holzer Clinic	Gallipolis	Ohio
United States	Female Pelvic Medicine and Urogynecology	Grand Rapids	Michigan
United States	Woman's Hospital of Texas	Houston	Texas
United States	Clinical Research of Tampa Bay	Hudson	Florida
United States	Rosemark Women Care Specialists	Idaho Falls	Idaho
United States	Bexar Clinical Trials	Irving	Texas
United States	The Jackson Clinic, PA	Jackson	Tennessee
United States	Red Rocks OB/GYN	Lakewood	Colorado
United States	Innovative Research of W. Florida	Largo	Florida
United States	Advanced Clinical Research	Medford	Oregon
United States	Gynecology and Obstetrics, P.C.	Memphis	Tennessee
United States	Women's Care Center, PLC	Memphis	Tennessee
United States	HWC Women's Research Center	Miamisburg	Ohio
United States	Montgomery Women's Health Associates, P.C.	Montgomery	Alabama
United States	Eastern Carolina Womens Center	New Bern	North Carolina
United States	Women's Health Care Specialists, PC	Paw Paw	Florida
United States	Precision Trials LLC	Phoenix	Arizona
United States	Atlanta North Gynecology, PC	Roswell	Georgia
United States	Salt Lake Research	Salt Lake City	Utah
United States	San Diego Clinical Research Center	San Diego	California
United States	Salt Lake Women's Center	Sandy	Utah
United States	Searcy Medical Center	Searcy	Arkansas
United States	Hillcrest Clinical Research, LLC	Simpsonville	South Carolina
United States	Northern Indiana Womens Health Research	South Bend	Indiana
United States	Tampa Bay Women's Healthcare Alliance, LLP	Tampa	Florida
United States	Comprehensive Clinical Trials, LLC	West Palm Beach	Florida
United States	Advanced Clinical Concepts	West Reading	Pennsylvania
United States	Lyndhurst Clinical Research	Winston Salem	North Carolina
United States	Winston-Salem Woman Care, PA	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Lumara Health, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Baseline -12 Weeks	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No