Randomized, Placebo-Controlled, Double-Blind, Parallel Design Trial of the Efficacy and Safety of Zestra® in Women With Mixed Desire/Interest/Arousal/Orgasm Disorders

Abstract

Over 256 women, age 21 to 65, with acquired mixed female sexual disorders participated in a 16-week randomized, placebo-controlled, double-blind study of Zestra®, a topical botanical preparation. Routine outcome instruments measured efficacy and safety. Zestra® was well tolerated. The only significant safety finding was mild-to-moderate genital burning seen only in Zestra®-treated subjects (14.6%). Zestra® provided significant desire, arousal, and treatment satisfaction benefits for a broadly generalized group of women with sexual difficulties.

ACKNOWLEDGMENTS

Lead Investigator: Julia R. Heiman, Bloomington, Indiana. Principal Investigators: Stanley Althof, West Palm Beach, Florida; Eugene Dula, Tarzana, California; Mitchell Efros, Garden City, New York; Marc Gittelman, Aventura, Florida; Evan Goldfischer, Poughkeepsie, New York; Andre Guay, Peabody, Massachusetts; Timothy Hlavinka, San Antonio, Texas; Joel Kaufman, Aurora, Colorado; Robert Segraves, Cleveland, Ohio; David Sandock, Milwaukee, Wisconsin; Christopher Steidle, Fort Wayne, Indiana; Kristene Whitmore, Philadelphia, Pennsylvania. Senior Research Monitor: Melody Ferguson, Grand Marais, Minnesota. Research Monitors: Joanne Hall, Morton Grove, Illinois; Jean Yeager, Lake Forest, Illinois. Data System Manager: Rima Peret, Caldwell, New Jersey. Database Consultant: Ridwan Shabsigh, R&D Frontiers LLC, Caldwell, New Jersey. Laboratory Services: LabConnect LLC, Seattle, Washington. Test Articles: Martin Crosby, Zestra Laboratories, Inc., Charleston, South Carolina. Funding: Zestra Laboratories, Inc., Charleston, South Carolina.