A Randomized, Double-Blind, Placebo-Controlled Research Study to Evaluate a
Novel Vulvar Cream Containing Cutaneous Lysate for Provoked Vestibulodynia
Women between the ages of 20 and 55 who are not pregnant or breastfeeding may be eligible to participate in this study. Women must experience pain with tampon insertion and/or intercourse that affects their sexual function, and practice a reliable form of birth control. Those with a history of diabetes, heart disease, HIV, hepatitis B or C, or menopause are not eligible. Women must be able to attend two clinic visits, plus two telephone interviews, and complete all questionnaires in English over the course of the 12-week study. The study cream and other related study tests will be provided at no cost.
Participating Centers:
The Centers for Vulvovaginal Disorders (Washington, DC)
Contact Hillary Tolson
202-887-0568
Principal Investigator: Andrew T. Goldstein, MD
Pelvic & Sexual Health Institute (Philadelphia, PA)
Contact Elizabeth Elias, CCRC
215-863-8100
Principal Investigator: Kristene Whitmore, MD
Co-Investigator: Susan Kellogg-Spadt, PhD, PA-C
San Diego Sexual Medicine (San Diego, CA)
Contact Margaret Carr
619-265-7691, information@sdsm.info
Principal Investigator: Irwin Goldstein, MD
Arizona Vulva Clinic (Phoenix, AZ)
Contact Gabrielle Rodriguez
602-265-1112
Principal Investigator: Joseph Brooks, MD
New York Center for Women’s Health Research (New York, NY)
Contact Lauren Pellegrino, WHNP-BE
649-290-9560
Principal Investigator: Kenneth A. Levey, MD