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

Phase 2

Completed

• Conditions: Vulvodynia
• Interventions: Drug: placebo; Drug: lidocaine; Drug: Lidocaine/Diphenhydramine

• Registration Number: NCT00590590
• Lead Sponsor: Lumara Health, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-12-26
• Study First Submitted QC: 2008-01-09
• Study First Posted: 2008-01-10
• Primary Completion: 2009-06
• Study Completion: 2009-07
• Results First Submitted: 2010-06-30
• Results First Submitted QC: 2011-01-13
• Results First Posted: 2011-02-09
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-29
• Last Update Posted: 2012-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 105

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3 (Placebo)	placebo	-
1 (Lidocaine)	lidocaine	-
2 (Lidocaine/Diphenhydramine)	Lidocaine/Diphenhydramine	-

Primary Outcome Measures

Name	Time	Method
Mean Marinoff Dyspareunia Scale Score (MDSS) at End of Treatment (12 Weeks)	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

Name	Time	Method
Change From Baseline in Marinoff Dyspareunia Scale Score at End of Treatment (12 Weeks)	Baseline -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]	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

Trial Locations

Locations (48)

Montgomery Women's Health Associates, P.C.; 🇺🇸 Montgomery, Alabama, United States

Star W. Research; 🇺🇸 Chandler, Arizona, United States

Precision Trials LLC; 🇺🇸 Phoenix, Arizona, United States

Searcy Medical Center; 🇺🇸 Searcy, Arkansas, United States

Universal Biopharma Research Institute, Inc.; 🇺🇸 Dinuba, California, United States

San Diego Clinical Research Center; 🇺🇸 San Diego, California, United States

Red Rocks OB/GYN; 🇺🇸 Lakewood, Colorado, United States

Taylor Associates/Gynecology; 🇺🇸 Farmington, Connecticut, United States

Women's Medical Research Group, LLC; 🇺🇸 Clearwater, Florida, United States

Clinical Research of Tampa Bay; 🇺🇸 Hudson, Florida, United States

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