Wiley Protocol in First Study on Biomimetic Hormone Therapy

The principal Investigator for the study is Assistant Professor Janith Williams, DNP, WHNP, RNC, and the co principal investigator is Julie Taguchi, MD, physician and research coordinator at Sansum Clinic Santa Barbara, California.

The study is an observational, prospective study of women ages 35 to 60 who are current users of compounded bioidentical hormone therapy (BHT). Clinical care of study participants will not be changed as a result of study participation. The duration of the study is three years. Outcomes to be monitored include quality of life, symptom relief, and impact of BHT on physical health including breast, endometrial, and cardiovascular measures.

Ten to twelve experienced volunteer primary care providers (PCP) will participate in this study. PCP's will randomly submit 20 current patients on multi-phasic physiologic dosing, 20 current patients on bi phasic, and 20 patients using continuous compounded BHT for study participation. Study staff will contact patients, review the study protocol, and obtain informed consent. Patients will complete standard menopausal questionnaires with proven reliability and validity annually. Lab results obtained as part of standard care, such as serum, urine, and saliva levels in addition to standard breast and pelvic imaging data will be submitted annually for analysis. Lab testing of BHT cream samples will also be performed.

These critically needed study results will be presented at national and international meetings, and will be submitted for publication in professional journals to share the findings with women's health care professionals. Results will be used to design a prospective, randomized clinical trial with the goal of standardizing BHT dosing and administration patterns.

The primary objectives of the study are to:

•    Examine clinical outcomes and quality of life indicators of patients receiving bioidentical hormone therapy at 10-12 primary care providers’ practices.
•   Compare the effectiveness and safety, and quality of life of participants using one of three dosing patterns for bio-identical hormones: multi-phasic physiologic, bi-phasic or continuous dosing.
•    Monitor lab and imaging data of women using these bio-identical hormones.
•   Evaluate the safety of the hormone regimens by tracking adverse events experienced by women using bioidentical hormone therapy prescribed by their PCP's.
•    Assess the performance of compounding pharmacies in standardizing the products.

The research study is accepting donations which can be sent to: Office of Women's Health Research Bioidentical Hormone Research Project, c/o Dr. Janith Williams, College of Nursing and Health Sciences, The University of Texas at Tyler, Tyler, Texas  75799. One hundred percent of the funds received will be applied to this project. Donations of any size are welcome and donors will receive a receipt for tax purposes and a letter recognizing contributions.

About Wiley Systems
Founded in 2003 in Santa Barbara, California T.S. Wiley is the developer of The Wiley Protocol®, a trademarked patent protected delivery system consisting of bio-identical estradiol and progesterone in topical cream preparations dosed in a rhythm to mimic the natural cyclic hormone levels replicated in serum blood produced by a twenty year-old woman.

The Wiley Protocol is a patent protected delivery system consisting of bio-identical estradiol and progesterone in topical cream preparations dosed to mimic the natural hormones produced by a twenty year-old woman. The creams and their amounts vary throughout the 28 day cycle to mimic the hormone levels of youth. The Protocol is the only bio-identical hormone replacement therapy (BHRT) that has ever been developed under the scrutiny of a practicing oncologist.

The Wiley Protocol is only available at compounding pharmacies that have agreed to the standardized methods, materials, packaging and recommended pricing. In exchange, Wiley Systems™ provides intellectual property and sells pre-stamped 28WP logo-bearing packaging consisting of bags, labels and syringes in the branded colors of purple and green. The Wiley Protocol name assures customers that they are receiving the authentic Wiley Protocol. 
T.S. Wiley recently testified before the Special Committee on Aging at the United States Senate in Washington D.C. where she presented her expertise and experience with menopause and bio-identical hormone replacement therapy, and the changing landscape of women’s health in later years, among other research. She addressed the fact that the Safe Compounding Drug Act of 2007 would severely restrict and possibly deny access to critical medications including those patients on bio-identical hormone replacement therapy.

Wiley’s revolutionary discovery is the fact that it’s the rhythm that matters in the accurate physiological replacement of hormones without side-effects for women in the second half of life. Wiley’s findings may have important implications across a wide range of areas, from the treatment of menopause and anti-aging to all of the other diseases of aging such as heart disease and stroke, Type II diabetes, cancer and Alzheimer’s disease.

As a medical writer and researcher in chronobiology, environmental endocrinology and circadian rhythmicity, T.S. Wiley is the author of “Sex, Lies & Menopause,” Harper Collins, 2005 and “Lights Out: Sleep, Sugar and Survival,” Pocket Books, 2000. Wiley’s CME accredited seminars on the natural history of endocrinology are attended by physicians from all over the world who are learning about The Wiley Protocol. Wiley’s revolutionary discovery that it may be the rhythm that matters in the accurate physiological replacement of hormones may have important implications across a wide range of areas, from the treatment of menopause and anti-aging to all of the other diseases of aging such as heart disease and stroke, Type II diabetes, cancer and Alzheimer’s disease.