Zestra Laboratories Completes Enrollment Of Its Clinical Trial In 200 Women With Mixed Sexual Dysfunction

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: zestraforwomen/articles/JSMT.pdf.




Complete information is available at zestra.


Zestra Laboratories Inc.

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