CHARLESTON, S.C., Nov. 7 /PRNewswire/ -- Zestra Laboratories Inc. today announced the completion of recruitment for its voluntary clinical trial of Zestra(R) Arousal Fluid in 200 women with mixed sexual dysfunction. The company is conducting this Phase 3 type study to evaluate the efficacy and safety of Zestra(R) compared to placebo oil in women diagnosed with mixed sexual disorders, including problems with interest, desire, arousal and orgasm. The study is a randomized, placebo-controlled, double-blind, parallel design trial conducted through in-home use in conjunction with sexual activities.
Primary evaluations of the product’s efficacy will be based on the women’s classifications of “successful and satisfactory” sexual encounters as recorded in diaries (FSEP(C)). Secondary evaluations of efficacy will include the women’s responses written in diaries to other questions, subject self- assessment questionnaires, the Female Sexual Function Index (FSFI(C)), two global assessment questions (GAQ), treatment satisfaction questionnaires (WITS(C)), the Beck Depression Inventory, the Dyadic Adjustment Scale (DAS), consumer testing surveys (Zestra Consumer Testing Survey (ZCTS(C)), a distress scale (Female Sexual Distress Scale(C)), sexual encounter frequency, and drop- out rates. Safety will be assessed by adverse event reports, physical examinations, and laboratory evaluations. No previous intervention study by any company has sought to identify and understand as many aspects of the forces that influence women’s sexual satisfaction.
Thirteen investigational sites throughout the United States have screened 297 women and their partners for the study. To date, 251 have qualified to enter the four-week un-blinded placebo run-in period. Currently 116 of the 200 women have completed the entire study, while 73 are still completing the trial.
Zestra Laboratories’ Chief Executive Officer Younis Zubchevich said: “We are extremely pleased that our large-scale clinical trial has reached this important milestone. This achievement further broadens Zestra’s(R) leadership position over any product as the first choice for addressing female sexual problems. Zestra is already sold nationwide in approximately 30,000 pharmacies, supermarkets, and other retailers. Internationally, Zestra(R) is sold throughout 15 countries, and distribution will include Canada by January 2007.”
The FDA does not require companies to conduct clinical trials of consumer products marketed under the Cosmetics Act. Zestra Laboratories created Zestra(R) as a result of extensive scientific research. To distinguish Zestra(R) among health-care professionals and consumers from the myriad of unproven “natural” and herbal products flooding the market, the company chose the high road of evidence-based scientific studies. As with its first published clinical study, Zestra Laboratories voluntarily decided to conduct the current trial to the FDA’s scientific standards.
The FDA has not approved any pharmaceutical products for the treatment of any form of Female Sexual Dysfunction (FSD). As reported by the Associated Press (AP), Reuters and other news media, Procter & Gamble has not been able to obtain approval in the United States for its transdermal testosterone patch (Intrinsa(R)) in women with sexual desire disorder. Pfizer was unable to obtain approval for a female indication for Viagra(R) as a treatment for female sexual arousal disorder (FSAD). TAP Pharmaceuticals tried and discontinued oral apomorphine, while Nastech tried and discontinued trials with intranasal apomorphine. Bayer, Pharmacia-Upjohn, and Icos/Lilly did not succeed with women’s trials of their products.
Zestra Laboratories’ Chairman and Chief Science Officer, Martin Crosby said, “The Associated Press (AP) recently published an article titled: ‘Vivus Arousal Disorder Drug Fails Study’ and ‘Vivus Shifting Focus After Female Sexual Arousal Disorder Drug Fails to Meet Goal in Trial.’ The remaining potential prescription products in development include topical alprostadil (Vivus and NexMed); various delivery systems (creams, gels, patches and sprays) of testosterone by BioSante, also Vivus, and others; flibanserin -- a mixed serotonin receptor agonist/antagonist (Boehringer Ingleheim); and intranasal melanocortin analog (Palatin Technologies). We believe most of these potential prescription products are years away from filing an NDA.”
Crosby added, “In 1997, Zestra Laboratories had already recognized the critical role of sexual sensation in triggering the entire cascade of events involved in female sexual response and pleasure, and thus began the development of Zestra(R).”
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 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). The full-text article is available at: http://www.zestraforwomen.com/articles/JSMT.pdf
Complete information is available at http://www.zestra.com. Corporate Contact: Zestra Laboratories, Inc. Mr. Younis Zubchevich, CEO 4055 Faber Place Drive, Suite 300 Charleston, SC 29405 843.402.0901 (phone) 843.402.0919 (fax) Email: younisz@zestra.com Website: www.zestra.com Media Contacts: Jolie Balido and Jeannie Salameh Hart Marketing Communications jolie@hartmc.comjeannie@hartmc.com 305.586.0419
Zestra Laboratories Inc.
CONTACT: Corporate, Mr. Younis Zubchevich, CEO of Zestra Laboratories,Inc., +1-843-402-0901, or fax, +1-843-402-0919, or younisz@zestra.com; orMedia, Jolie Balido, jolie@hartmc.com, or Jeannie Salameh,jeannie@hartmc.com, both of Hart Marketing Communications, +1-305-586-0419
Web site: http://www.zestra.com/
