CHARLESTON, S.C., April 3 /PRNewswire/ -- Zestra Laboratories, Inc. today announced the beginning of enrollment of the National Institutes of Health (NIH) - registered Phase 3-type clinical study of its commercially available non-prescription product, Zestra(R) Feminine Arousal Fluid. Zestra(R) is the only consumer product available that is clinically shown to quickly increase female sexual sensation, arousal, pleasure, and improve sexual experiences for women.
Multi-Center Study / Randomized, Placebo-Controlled, Double-Blind, Parallel Design Trial
The Company announced the acceptance of this clinical trial of Zestra(R) by the NIH on July 20, 2005. This Phase 3-type study is evaluating the efficacy and safety of Zestra(R) compared to placebo oil in 200 women diagnosed with acquired mixed interest/desire/arousal/orgasm disorders in conditions of home use in conjunction with sexual activities. The Zestra(R) study is the only NIH-registered study to directly address women’s sexual problems.
This multi-center study (16 research sites), designed by David M. Ferguson, PhD, MD, FACCP, is a randomized, placebo-controlled, double-blind, parallel design trial. Primary efficacy assessment will be the subjects’ assessments of “successful and satisfactory” sexual encounters as recorded in a diary (FSEP(C)). Secondary evaluations of efficacy will include the other diary questions, a subject self-assessment questionnaire (Female Sexual Function Index (FSFI)(C)), two global assessment questions (GAQ), a treatment satisfaction questionnaire (WITS(C)), the Beck Depression Inventory, the Dyadic Adjustment Scale (DAS), a consumer testing survey (QualiLife Consumer Testing Survey (QCTS(C)), a distress scale (Female Sexual Distress Scale (FSDS)(C)), sexual encounter frequency and drop-out rates.
The Zestra(R) clinical study description along with study site investigators and locations can be viewed at http://www.ClinicalTrials.gov by entering any of the following search terms: female sexual dysfunction, hypoactive sexual desire disorder, sexual arousal disorder, orgasmic disorder or Zestra. The International Committee of Medical Journal Editors (ICJME) has established a requirement that all clinical trials be entered in a public registry before the onset of enrollment, as a condition of consideration for publication. Zestra Laboratories intends to update the trial data as the study progresses and to publish the results in a peer-reviewed journal.
Prevalence of Women’s Sexual Difficulties
According to the 2005 Obstetrics and Gynecologic Survey CME Review article Female Sexual Dysfunction: Principles of Diagnosis and Therapy, “Female sexual dysfunction is a common health problem, affecting approximately 43% of women. Female sexual dysfunction is defined as disorders of libido, arousal, orgasm, and sexual pain that lead to personal distress or interpersonal difficulties.” There are currently no FDA-approved prescription drug treatments for women experiencing any form of Female Sexual Dysfunction or Disorders (FSD).
“The most commonly experienced sexual problems in women are primarily caused by reduced clitoral and vaginal ‘sensation’ during sexual stimulation. Decreased sexual sensation (which can be due to aging, diabetes, birthing, pelvic surgery or nerve damage, is also commonly caused by several types of widely-used prescription drugs such as: antidepressants, bladder control medications, blood pressure medications, antihistamines and hormonal contraceptives) inhibits arousal, pleasure, orgasm and creates difficulty for women to enjoy satisfying sexual experiences. Likewise, when female sexual pleasure is reduced or absent, this clearly dampens libido/desire” said pharmaceutical scientist and sexual health researcher Martin Crosby, Chairman and Chief Science Officer of Zestra Laboratories, Inc. “This effect on desire,’ according to sex educator, researcher, and author Beverly Whipple, PhD, RN, FAAN, professor emerita at Rutgers University, is described in (Whipple and BrashMcGreer’s) Circular Model of Female Sexual Response showing how pleasure and satisfaction during one sexual experience can lead to the seduction phase of the next sexual experience. ‘If, during reflection, the sexual experience did not provide pleasure and satisfaction, the woman may not have a desire to repeat the experience.”
Turning Back the Intimacy Clock
“The robust outcome of the initial published clinical study results of Zestra(R) in 2003 and growing support and recommendations from healthcare professionals worldwide led to a nationwide rollout of Zestra(R) in major chain pharmacies beginning in mid-2005. Non-prescription Zestra(R) is satisfying a large unmet need as the first meaningful solution for millions of women who experience very common sexual problems,” said Alan Fink, President of privately-held Zestra Laboratories, Inc. “For baby boomers in particular, trying to recapture some of the pleasures and excitement of youth are much more than just lifestyle choices. With Zestra(R), women are now finding the solution to quickly ‘turn back their intimacy clock.”
Elizabeth Baron-Kuhn, a Board-Certified Ob/Gyn explains, “While men were generally experiencing their own changes at this stage of life in sexuality, albeit at a slower rate, the two sexes seemed destined to ride a somewhat parallel set of tracks into the sunset of their intimacy and sexuality as time progressed. But those parallel tracks were diverted when Viagra(R) (Pfizer) and other male ED drugs appeared on the medical scene for men. Women then began an even more frustrating time with intimacy challenges and the change in their sexual responses to their partners. For many women, Zestra(R) may help bring together those disparate parallel tracks of male and female intimacy that men’s ED products seem to amplify.”
About Zestra(R) Feminine Arousal Fluid (U.S. Patent 6,737,084)
Zestra(R) Feminine Arousal Fluid is topically applied, hormone-free and is not a drug. Zestra(R) is a patented formulation (U.S. Patent 6,737,084) of two botanical oils and two extracts -- specifically designed to increase sexual sensation, arousal, pleasure and satisfaction for women. Its well-studied natural ingredients are FDA recognized as dietary supplements and natural cosmetic ingredients. Non-prescription Zestra(R) is marketed under the FDA Cosmetics Act to improve sexual experiences for women. A previous phase 2-type randomized, placebo controlled, double blind, cross-over design trial demonstrated Zestra(R) produced these desired effects in women with and without FSD regardless of menopausal status, antidepressant usage, or oral contraceptive usage (Journal of Sex and Marital Therapy 2003;29 Supplement 1:33-44). This new study will increase the number and diversity of women tested with Zestra(R). See article abstract on PubMed. The full-text article is available at: http://www.zestraforwomen.com/articles/JSMT.pdf.
The benefits of Zestra(R) are widely cited in peer-reviewed medical journals, Continuing Medical Education (CME) Review Articles, recently published books, the lay press, and general media.
Where to Buy Zestra(R)
Non-prescription Zestra(R) is available nationwide in the feminine hygiene section or in the family planning section of CVS Pharmacies, Walgreens, Rite Aid, Duane Reade drugstores, HEB supermarkets, and certain natural products stores. Zestra(R) is also available in China, Taiwan, H.K., Korea, Malaysia & Singapore.
Complete information is available at http://www.zestraforwomen.com . The Zestra(R) Package Insert is at: http://www.zestraforwomen.com/PackageInsert.pdf .
About Zestra Laboratories
Zestra Laboratories is a science-driven company focused on developing clinically-proven consumer products in women’s health. While there is no requirement by the FDA for manufacturers to conduct clinical trials of products marketed as consumer products, dietary supplements or cosmetics, Zestra Laboratories has chosen to conduct evidence-based scientific studies. As with its first clinical trial, this 200-women Zestra(R) study is conducted to FDA scientific standards.
Since 1996, the Company has leveraged its expertise in pharmaceutical technologies, natural products, and women’s sexual health to “design and develop” proprietary consumer products with significant commercial potential. Zestra Laboratories believes this “design and develop” strategy increases the chances of successfully developing effective and widely embraced consumer products. These target areas involve products that deliver substantial quality of life enhancements in women’s health. The Company currently markets Zestra(R) in the U.S., and internationally through distributors.
Contact: For Zestra Laboratories, Inc. Martin G. Crosby, R.Ph. Chairman and Chief Science Officer Tel: 843.402.0901 mcrosby@zestraforwomen.com
Zestra Laboratories, Inc.
CONTACT: Martin G. Crosby, R.Ph., Chairman and Chief Science Officer ofZestra Laboratories, Inc., +1-843-402-0901, mcrosby@zestraforwomen.com
Web site: http://www.zestraforwomen.com/
