Women's Sexual Health Study Shows Positive Results for Zestra(R) Feminine Arousal Fluid

Women's Sexual Health Study Shows Positive Results for Zestra(R) Feminine Arousal Fluid

Zestra Laboratories Launches TV Campaign for Zestra(R) Feminine Arousal Fluid and Announces New Trial-Size Box with Expanded Retail Distribution

Zestra(R) Large-Scale Multi-Center Clinical Study Results

CHARLESTON, S.C., July 11 /PRNewswire/ -- Zestra Laboratories announced primary results for its large-scale clinical study examining the potential of its widely available, non-hormonal, non-prescription Zestra(R) Feminine Arousal Fluid for improving the sexual experiences of women. This multi-center study, designed and managed by David M. Ferguson, PhD, MD, FACCP, is a randomized, placebo-controlled, double-blind, parallel design trial intended to expand on the results of the Phase 2 type study conducted in 2001. Efficacy assessments included the widely used, validated subject self-assessment questionnaire, the Female Sexual Function Index (FSFI). This Phase 3-type study evaluated the efficacy and safety of Zestra(R) compared to placebo oil in approximately 200 women diagnosed with acquired mixed interest/ desire/ arousal/ orgasm disorders in conditions of home use in conjunction with sexual activities.

Of the 296 women screened at 13 research sites, 256 were randomized to Zestra(R) or placebo. A total of 178 completed the entire study. There were no serious adverse events (SAEs) associated with study participants' use of Zestra(R) or placebo oil. Dr. Ferguson said, "The safety profile seen in this study reconfirms that of the earlier published study: Zestra(R) was well tolerated."

Analysis of the FSFI questionnaires indicated that Zestra(R) provided a significant benefit over placebo in the desire and satisfaction domains (P < 0.05), while showing a highly significant (P < 0.005) benefit over placebo in the arousal domain. Additionally, the total FSFI score showed a significant improvement over placebo (P < 0.05). These results confirm the arousal and satisfaction benefits seen in the previous published clinical trial of Zestra(R). The new, and unexpected result, is the significant benefit in the desire domain. All of these results can be interpreted as showing that Zestra(R) is well tolerated and provides desire, arousal, and sexual satisfaction benefits for a broad, generalized group of women with sexual difficulties.

"Although the Food and Drug Administration does not require clinical trials of non-prescription consumer products, Zestra Laboratories elected to conduct a Phase III-type FDA-quality study to further assess the product's safety and effectiveness," said Martin Crosby, Zestra's developer. "Our collaboration with the nation's leading medical and sexual health experts and our commitment to research demonstrate our intent to advance the science of female sexual health and provide a meaningful and safe solution for women today." Despite a decade of prescription pharmaceutical research in female sexual disorders, and several effective prescription treatments for erectile dysfunction (ED), there is still no FDA-approved drug treatment for any form of female sexual dysfunction or disorder.

"Results from the Zestra(R) study will provide important direction for future studies in women's sexual health," said Dr. Ferguson. "Because the study has only just concluded, there is a significant amount of additional valuable information in the database that we will analyze in great detail over the coming months," he said.

About Zestra(R) Feminine Arousal Fluid (U.S. Patent 6,737,084)

Zestra Laboratories, Inc., a specialty consumer health products company, is the developer and manufacturer of Zestra(R) Feminine Arousal Fluid, a patented all-natural formulation of two botanical oils and two extracts. It is the only consumer product clinically shown to quickly increase female sexual desire, sensation, arousal and satisfaction. Because Zestra(R) was specifically designed for the needs of women: it is hormone-free, paraben- free, and glycerin-free. Zestra(R), which is easy to use and topically applied, begins increasing female sexual sensation, arousal and pleasure in three to five minutes. The effects of each application last up to 45 minutes. For complete product information, visit www.zestra.com.

Expanded Retail Distribution of Zestra(R) Feminine Arousal Fluid

"Last year at this time, Zestra(R) Feminine Arousal Fluid was distributed by 14,000 retail pharmacies including Walgreens, CVS, RiteAid/Brooks/Eckerd and Duane Reade," says Alan Fink, President of Zestra Laboratories. "Today, distribution has expanded to more than 35,000 outlets including nearly every major drug chain, supermarket chain and discount chain in the USA. Distribution continues expanding at a rapid pace and now includes WalMart." Fink added, "Zestra(R) enjoys the unique advantage of being the only product available in retail stores with statistically proven results from well- designed, placebo-controlled clinical studies conducted by leading research experts in the field of women's sexual health."

For online purchasing, Zestra(R) is available from the following e-commerce retailers: www.drugstore.com, www.walgreens.com, www.cvs.com, and the AARP Pharmacy Services Product Catalog www.aarppharmacycatalog.com.

To find Zestra(R) at stores near you, enter your Zip Code in the store locator link: www.zestra.com/StoreLocator/ .

New "Trial-Size" Box

Zestra Laboratories has introduced a 3-Pack "Trial-Size" box of three Zestra(R) sachets (MSRP $9.99) to make women's first trial of Zestra(R) very affordable. Mr. Fink says, "This package augments the current 9-Pack (MSRP $24.95) which provides a more economical purchase for dedicated Zestra(R) consumers. Most retailers are offering both sizes." Product photo shots are found here: http://www.zestra.com/ZestraBoxPhoto.jpg

New Television Campaign for Zestra(R) Feminine Arousal Fluid

Crosby and Fink announce the launching of a national television campaign for 15 and 30 second versions of the tasteful Zestra(R) advertisements that first aired last fall. Cable channels already airing the ads include A&E, E!, Oxygen, Fox News, TNT, and Court TV. The campaign began Monday July 9, 2007. Fink says, "This campaign will provide tremendous consumer awareness of our product and will support the fine retailers who distribute it." Crosby says, "With the outstanding clinical study results, expansion of our distribution, and introduction of the 3-pack box, this television campaign should have a major impact on our sales." The 15-second TV commercial can be viewed here: http://www.zestra.com/Zestra15Commercial.wmv

Company Contacts:

Martin Crosby Alan Fink
Chairman, CEO, and Chief Science Officer President
Tel: 843-402-0901 Tel: 843-402-0901
Fax: 843-402-0919 Fax: 843-402-0919
Email: mcrosby@zestra.com Email: afink@zestra.com
Company website: www.zestra.com

First Call Analyst:
FCMN Contact:

Source: Zestra Laboratories

CONTACT: Martin Crosby, Chairman, CEO, and Chief Science Officer,
mcrosby@zestra.com, or Alan Fink, President, afink@zestra.com, both of Zestra
Laboratories, +1-843-402-0901, or fax, +1-843-402-0919

Web site:

http://www.zestraforwomen.com/
http://www.zestra.com/
http://www.zestra.com/Zestra15Commercial.wmv

NOTE TO EDITORS: Interviews with Advisory Board members are available

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