Clinical trial NCT00590590: Safety and Efficacy of Two Vaginal Products Versus Placebo in Patients With Vaginal Discomfort
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Vulvodynia
Lead sponsor: Lumara Health, Inc.
Sponsor class: INDUSTRY
First posted: 2008-01-10
Enrollment: 105
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Mean Marinoff Dyspareunia Scale Score (MDSS) at End of Treatment (12 Weeks)
timeFrame: 12 weeks
Secondary outcomes:
measure: Change From Baseline in Marinoff Dyspareunia Scale Score at End of Treatment (12 Weeks)
timeFrame: Baseline -12 Weeks
measure: 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]
timeFrame: 12 Weeks
measure: 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]
timeFrame: 12 weeks
measure: 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]
timeFrame: 12 Weeks
measure: 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]
timeFrame: 12 Weeks
Other outcomes:
Locations:
city: Montgomery
country: United States
facility: Montgomery Women's Health Associates, P.C.
state: Alabama
city: Chandler
country: United States
facility: Star W. Research
state: Arizona
city: Phoenix
country: United States
facility: Precision Trials LLC
state: Arizona
city: Searcy
country: United States
facility: Searcy Medical Center
state: Arkansas
city: Dinuba
country: United States
facility: Universal Biopharma Research Institute, Inc.
state: California
city: San Diego
country: United States
facility: San Diego Clinical Research Center
state: California
city: Lakewood
country: United States
facility: Red Rocks OB/GYN
state: Colorado
city: Farmington
country: United States
facility: Taylor Associates/Gynecology
state: Connecticut
city: Clearwater
country: United States
facility: Women's Medical Research Group, LLC
state: Florida
city: Hudson
country: United States
facility: Clinical Research of Tampa Bay
state: Florida
city: Largo
country: United States
facility: Innovative Research of W. Florida
state: Florida
city: Paw Paw
country: United States
facility: Women's Health Care Specialists, PC
state: Florida
city: Tampa
country: United States
facility: Tampa Bay Women's Healthcare Alliance, LLP
state: Florida
city: West Palm Beach
country: United States
facility: Comprehensive Clinical Trials, LLC
state: Florida
city: Atlanta
country: United States
facility: Atlanta Women's Research Institute, Inc.
state: Georgia
city: Roswell
country: United States
facility: Atlanta North Gynecology, PC
state: Georgia
city: Boise
country: United States
facility: Womans Clinic
state: Idaho
city: Idaho Falls
country: United States
facility: Rosemark Women Care Specialists
state: Idaho
city: Champaign
country: United States
facility: Women's Health Practice, LLC
state: Illinois
city: South Bend
country: United States
facility: Northern Indiana Womens Health Research
state: Indiana
city: Grand Rapids
country: United States
facility: Female Pelvic Medicine and Urogynecology
state: Michigan
city: Brooklyn
country: United States
facility: Boro Park ObGyn
state: New York
city: New Bern
country: United States
facility: Eastern Carolina Womens Center
state: North Carolina
city: Winston Salem
country: United States
facility: Lyndhurst Clinical Research
state: North Carolina
city: Winston-Salem
country: United States
facility: Winston-Salem Woman Care, PA
state: North Carolina
city: Gallipolis
country: United States
facility: Holzer Clinic
state: Ohio
city: Miamisburg
country: United States
facility: HWC Women's Research Center
state: Ohio
city: Medford
country: United States
facility: Advanced Clinical Research
state: Oregon
city: Allentown
country: United States
facility: Lehigh Valley Health Network
state: Pennsylvania
city: West Reading
country: United States
facility: Advanced Clinical Concepts
state: Pennsylvania
city: Simpsonville
country: United States
facility: Hillcrest Clinical Research, LLC
state: South Carolina
city: Chattanooga
country: United States
facility: Southeastern Clinical Research
state: Tennessee
city: Jackson
country: United States
facility: The Jackson Clinic, PA
state: Tennessee
city: Memphis
country: United States
facility: Women's Care Center, PLC
state: Tennessee
city: Memphis
country: United States
facility: Gynecology and Obstetrics, P.C.
state: Tennessee
city: Austin
country: United States
facility: Professional Quality Research/Women Partners
state: Texas
city: Corpus Christi
country: United States
facility: Advanced Research Associates
state: Texas
city: Houston
country: United States
facility: Woman's Hospital of Texas
state: Texas
city: Irving
country: United States
facility: Bexar Clinical Trials
state: Texas
city: Salt Lake City
country: United States
facility: Salt Lake Research
state: Utah
city: Sandy
country: United States
facility: Salt Lake Women's Center
state: Utah
city: Coquitlam
country: Canada
facility: Gain Medical Centre
state: British Columbia
city: North Vancouver
country: Canada
facility: Stephen Kaye, MD
state: British Columbia
city: White Rock
country: Canada
facility: Southern Healthcare Centre
state: British Columbia
city: Mt. Pearl
country: Canada
facility: Common Wealth Medical Clinic
state: Newfoundland and Labrador
city: Ottawa
country: Canada
facility: The Ottawa Hospital-Soundcare Medical Centre
state: Ontario
city: Toronto
country: Canada
facility: Royal Health Care Centre
state: Ontario
city: Windsor
country: Canada
facility: Windsor Metropolitan Hospital
state: Ontario
Study officials:
affiliation: Lumara Health, Inc.
name: Jim Joffrion
role: STUDY_DIRECTOR
References: