Initial Consumer Testing Evaluation:
Preliminary safety and efficacy of Zestra™ for Women in premenopausal and postmenopausal normal women interested in increasing sexual pleasure, and women with self-described sexual difficulties or decreased sexual pleasure.
Date of Completion: 9-8-9
OBJECTIVE: Vasoactive pharmaceutical compounds have been demonstrated to be safe and effective in the treatment of men with erectile dysfunction. Researchers report that approximately 43% of women suffer some degree of female sexual dysfunction (FSD) with symptoms increasing with age. With the exception of prostaglandin E-1 and nitroglycerin, the role of topically applied vasoactive substances in treating women with sexual dysfunction has heretofore not been reported (9-8-98). The objective of our research was to develop a topically applied botanical product to enhance female sexual pleasure in normal healthy women and perhaps represent a potential help for those with decreased sexual pleasure. Zestra™ for Women is a topical formulation containing natural bio-active botanical substances that have favorable safety profiles which are well documented in the medical and scientific literature. We ascertained the response of evolving formulations of Zestra™ for Women resulting in the current formula that we believe offers the greatest efficacy.
METHODS: Inclusion criteria was non-restrictive in that thirty eight (38) premenopausal and postmenopausal women (aged 21-52), representing a highly diverse population, were allowed to voluntarily participate without compensation. While many presented themselves as sexually normal with an interest in increasing their sexual pleasure, others had self-reported various forms of sexual dissatisfaction or lack of sexual pleasure. Many of those women had one or more of the following complaints: loss or decrease of sexual sensation, loss or difficulty with arousal, difficulty with orgasm, difficulty with lubrication and a lack of sexual enjoyment or pleasure. All participants received 1.5ml of Zestra™ for Women in a plastic squeeze tube with a dropper-tip dispenser. Efficacy was assessed immediately after use with a self administered non-validated questionnaire on the effects of female sexual function, sexual pleasure, adverse reactions and effects on sexual partner. The questionnaire addressed the domains of: arousal, quality of sexual intercourse, overall satisfaction with sexual pleasure, orgasm, and clitoral and vaginal sensation.
QUALITATIVE RESULTS: Most of the women reported satisfactory or noticeable improvements in one or more of the following areas: arousal, genital warmth, heightened clitoral and vaginal sensitivity and engorgement, orgasmic ability, lubrication and sexual pleasure. Zestra™ for Women's effects generally began within 5 minutes of application and lasted for 30-45 minutes.
CONCLUSIONS: This preliminary consumer evaluation (9-8-98) of early product formulations suggests that Zestra™ for Women is well-tolerated in premenopausal and postmenopausal women with or without sexual difficulties. Overall sexual satisfaction improved, with increased arousal parameters, clitoral and vaginal sensitivity, and orgasm. This preliminary consumer evaluation also suggests the potential role of Zestra™ for Women in helping with decreased sexual pleasure.
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