(CHARLESTON, SC) December 4, 2001 /PRNewswire.com/ - QualiLife Pharmaceuticals, Inc. today announced the final results of its pilot
safety and efficacy study of Zestra™ for Women. Zestra™ for Women is a topically applied, botanical feminine massage oil formulated to
enhance
female
sexual pleasure, increase warmth, sensitivity & sensation, & facilitate arousal when applied to the clitoris, labia, and vaginal opening.
Zestra™ for
Women is not a drug. This product is not intended to diagnose, treat, cure, or prevent any disease and has not been evaluated by the FDA.
The title of the study was: RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE BLIND, CROSSOVER DESIGN PILOT TRIAL OF THE EFFICACY AND SAFETY OF ZESTRA™ FOR
WOMEN IN WOMEN WITH, AND WITHOUT, FEMALE SEXUAL AROUSAL DISORDER by D. Ferguson, C. Steidle, G. Singh, S. Alexander, K. Weihmiller, and M.
Crosby. Zestra™ for Women was studied in 10 normal women and 10 women with Female Sexual Arousal Disorder (FSAD), in at-home use.
Zestra™ for
Women showed statistically significant (P < .05) benefits over placebo for both groups in the primary efficacy variable, diary-based satisfaction with
level
of arousal (Female Sexual Encounter Profile©, question 3). Secondary efficacy variables that showed significant improvement included level of
desire (Both, P<.001), level of arousal (Both, P<.01), genital sensation (Both, P<.001), and sexual pleasure (Both, P<.01). FSAD women showed
increased frequency of orgasms (P<.05), while the normal women indicated an enhanced ability to attain orgasm (P<.05). Zestra™ for Women was
well
tolerated by both groups.
"This study is a landmark in testing non-device products in women with FSAD. This is the first study to show positive results in at-home conditions."
said Dr. Ferguson, a prominent researcher in sexual dysfunction studies and consultant for QualiLife who managed the study.
About QualiLife Pharmaceuticals, Inc. (Women's Consumer Product Division)
QualiLife Pharmaceuticals, Inc. is a privately held Delaware corporation based in Charleston, SC. To maximize the commercial opportunity of the
proprietary Women's Sexual Health consumer product Zestra™ for Women, the Company intends to seek a corporate partner such as a major
pharmaceutical
company with a strong consumer products division. The Company will exhibit at the Sexual Medicine Society of North America conference in Charleston
December 7th - 9th.
Contact: Martin G. Crosby, RPh. - Chairman & Chief Science Officer
843.402.0901 or mcrosby@zestra-women.com
Industry: Health, Pharmaceutical
Keywords: South Carolina, Delaware
Download the PDF version.
