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

Condition(s) targeted: Vulvodynia

Intervention: Lidocaine/Diphenhydramine (Drug); lidocaine (Drug); placebo (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: KV Pharmaceutical Company

Official(s) and/or principal investigator(s):
Chang Lee, MD, Study Director, Affiliation: KV Pharmaceutical Company

Overall contact:
Chang Lee, MD, Phone: 877-567-7676

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.

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment

Primary outcome: The primary outcome measure of the study will be measurement of a woman's ability to have vaginal intercourse.

Secondary outcome: Important secondary outcome measures include change in discomfort.

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Female.

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.

Chang Lee, MD, Phone: 877-567-7676

Montgomery Women's Health Associates, P.C., Montgomery, Alabama 36116, United States; Recruiting

Precision Trials LLC, Phoenix, Arizona 85032, United States; Recruiting

Star W. Research, Chandler, Arizona 85225, United States; Recruiting

Searcy Medical Center, Searcy, Arkansas 72143, United States; Recruiting

Universal Biopharma Research Institute, Inc., Dinuba, California 93618, United States; Recruiting

San Diego Clinical Research Center, San Diego, California 92103, United States; Recruiting

Red Rocks OB/GYN, Lakewood, Colorado 80228, United States; Recruiting

Taylor Associates/Gynecology, Farmington, Connecticut, United States; Recruiting

Comprehensive Clinical Trials, LLC, West Palm Beach, Florida 33409, United States; Recruiting

Clinical Research of Tampa Bay, Hudson, Florida 34667, United States; Recruiting

Tampa Bay Women's Healthcare Alliance, LLP, Tampa, Florida 33607, United States; Recruiting

Innovative Research of W. Florida, Largo, Florida 33770, United States; Recruiting

Women's Medical Research Group, LLC, Clearwater, Florida 33759, United States; Recruiting

Women's Health Care Specialists, PC, Paw Paw, Florida 49079, United States; Recruiting

Atlanta North Gynecology, PC, Roswell, Georgia 30075, United States; Recruiting

Atlanta Women's Research Institute, Inc., Atlanta, Georgia 30342, United States; Recruiting

Rosemark Women Care Specialists, Idaho Falls, Idaho 83404, United States; Recruiting

Womans Clinic, Boise, Idaho 83712, United States; Recruiting

Women's Health Practice, LLC, Champaign, Illinois 61820, United States; Recruiting

Northern Indiana Womens Health Research, South Bend, Indiana 46601, United States; Recruiting

Female Pelvic Medicine and Urogynecology, Grand Rapids, Michigan 49506, United States; Recruiting

Boro Park ObGyn, Brooklyn, New York 11219, United States; Recruiting

Lyndhurst Clinical Research, Winston Salem, North Carolina 27103, United States; Recruiting

Winston-Salem Woman Care, PA, Winston-Salem, North Carolina 27103, United States; Recruiting

Eastern Carolina Womens Center, New Bern, North Carolina 28562, United States; Recruiting

HWC Women's Research Center, Miamisburg, Ohio 45342, United States; Recruiting

Holzer Clinic, Gallipolis, Ohio 45631, United States; Recruiting

Advanced Clinical Research, Medford, Oregon 97504, United States; Recruiting

Advanced Clinical Concepts, West Reading, Pennsylvania 19611, United States; Recruiting

Lehigh Valley Health Network, Allentown, Pennsylvania 18105, United States; Recruiting

Hillcrest Clinical Research, LLC, Simpsonville, South Carolina 29681, United States; Recruiting

Southeastern Clinical Research, Chattanooga, Tennessee 37403, United States; Recruiting

Gynecology and Obstetrics, P.C., Memphis, Tennessee 38120, United States; Recruiting

Women's Care Center, PLC, Memphis, Tennessee 38119, United States; Recruiting

The Jackson Clinic, PA, Jackson, Tennessee 38305, United States; Recruiting

Advanced Research Associates, Corpus Christi, Texas 78414, United States; Recruiting

Professional Quality Research/Women Partners, Austin, Texas 78705, United States; Recruiting

Woman's Hospital of Texas, Houston, Texas 77054, United States; Recruiting

Bexar Clinical Trials, Irving, Texas 75061, United States; Recruiting

Salt Lake Women's Center, Sandy, Utah 84070, United States; Recruiting

Salt Lake Research, Salt Lake City, Utah 84107, United States; Recruiting

Starting date: October 2007
Last updated: August 4, 2008