The study 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©). Secondary evaluations of efficacy will include the other diary questions, a subject self assessment questionnaire (Female Sexual Function Index (FSFI)®), two global assessment questions (GAQ), a treatment satisfaction questionnaire (WITS©), the Beck Depression Inventory, the Dyadic Adjustment Scale (DAS), a consumer testing survey (QualiLife Consumer Testing Survey (QCTS©), a distress scale (Female Sexual Distress Scale (FSDS)©), sexual encounter frequency and drop-out rates.
The ZestraTM study description can be viewed at 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 patient enrollment, as a condition of consideration for publication. QualiLife intends to update the trial data as the study progresses and to publish the results in a prominent peer-reviewed journal.
ZestraTM feminine arousal fluid is topically applied, hormone-free and is not a drug. ZestraTM 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 ZestraTM 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 ZestraTM 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 expanded study will increase the number and diversity of women tested with ZestraTM. See article abstract on PubMed. The full-text article is available at: http://www.zestraforwomen.com/articles/JSMT2003.
New Scientific Evidence Guides Research Directions
Recently published studies have raised questions about what really improves sex for women. Testosterone and blood flow appear to be of secondary importance to sensation.1,2 Seven years ago, QualiLife Pharmaceuticals recognized the critical role of sexual sensation in triggering the entire cascade of events involved in female sexual response and pleasure. The role of sensation is now at the forefront of female sexual medicine research.
Recently published research in the American Journal of Obstetrics and Gynecology (ACOG) has confirmed that decreased clitoral sensation is the single common theme in FSD. "Decreased tactile sensation was found at the clitoris for women with total sexual dysfunction, desire disorder and arousal disorder. Women with arousal disorder also had decreased tactile sensation at the perineum." See ACOG article abstract on PubMed.
QualiLife Pharmaceuticals developed ZestraTM by combining its focused expertise in women's sexual health with highly-studied botanical ingredients. While there is no requirement by the FDA for manufacturers to conduct clinical trials of products marketed as consumer products, dietary supplements or cosmetics, QualiLife chose to conduct evidence-based scientific studies. As with its first clinical trial, this expanded ZestraTM study is conducted to FDA scientific standards.
Drug Development Landscape
At this time, no prescription drugs are FDA approved for the treatment of female sexual dysfunction. There are approximately 10 publicly-traded drug companies researching potential prescription treatments for various forms of female sexual dysfunction (FSD). Current prescription drugs under development include topical alprostadil, many delivery systems for testosterone and intranasal melanocortin analog. Most of these are several years away from filing an NDA.
Beneficial Options Available Today
Sexual health researchers, women's healthcare providers and professional organizations are diligently working to better understand female sexual response and are using multi-disciplinary approaches (medical and psychological evaluation, sex therapy and proven non-prescription products) to address female sexual distress. ZestraTM is one of only two non-prescription products that have well-designed, well-controlled clinical trials published in peer-reviewed medical journals. The makers of ZestraTM continue to advance women's options through its voluntary program of conducting clinical trials to FDA standards.
About ZestraTM Feminine Arousal Fluid (U.S. Patent 6,737,084)
ZestraTM is designed to increase female sexual sensation, arousal and pleasure when topically applied. The ingredients in ZestraTM are not found in any other women's sexual product. No other product is proven to be more effective for increasing female sexual pleasure, satisfaction or libido. Ingredients: PA-Free Borage Seed Oil, Evening Primrose Oil, Angelica Extract, Coleus Extract, Vitamin C, Vitamin E and natural fragrances. More information is available at www.zestraforwomen.com
In the United States, ZestraTM is available nationwide in Walgreen's, CVS and Duane Reade drugstores in NYC. ZestraTM will also be available in Rite Aid pharmacies beginning August 1st.
ZestraTM is also available in Asia/Pacific Rim, United Kingdom, Ireland and South Africa. To learn more visit www.zestra-asia.com, www.zestraforwomen.co.uk and www.zestra.co.za.
About QualiLife Pharmaceuticals, Inc.
QualiLife Pharmaceuticals, Inc. is a science-driven company focused on developing clinically proven consumer products for Women's Health. Since 1996, the Company has leveraged its expertise in pharmacology, pharmaceutical technologies and women's sexual health to "design and develop" patented consumer products for large unsatisfied markets.
References:
(1) Journal of the American Medical Association, July 6, 2005; vol 294: pp 91-96. Susan Davis, MD, PhD, Women's Health Program, Department of Medicine, Monash Medical School, Alfred Hospital, Victoria, Australia. See article abstract on PubMed.
(2) American Journal of Obstetrics & Gynecology, Vol. 192, No. 5 (May 2005), Kathleen Connell, MD; Marsha K. Guess, MD; Julie La Combe, MD; Andrea Wang, MD; Kenneth Powers, MD; George Lazarou, MD; Magdy Mikhail, MD; Yale School of Medicine and the Albert Einstein College of Medicine. See article abstract on PubMed.