UT Tyler and UTHCT Seeking Women to Participate in Study

March 3, 2005

The Center for Excellence in Women’s Health Research and Outreach of The University of Texas at Tyler College of Nursing and Health Sciences and The University of Texas Health Center at Tyler is seeking participants for a research study called C.H.O.I.I.C.E that involves bioidentical hormones in women.

The purpose of this study is to examine the effects of bioidentical hormone therapy cream on improving the overall quality of life and reducing the risks of cardiovascular disease in women between 30 and 65 years of age.

Informational recruitment meetings will be held at the UT Tyler Robert R. Muntz Library, room 401 at 4:30 p.m. and 6:30 p.m. on March 8, 21, 22, 23, 24, 29, 30 and 31. Saturday meetings will take place on April 9 at noon and 2:30 p.m. in the same location.

C.H.O.I.I.C.E stands for Compounded Bioidentical Hormone Replacement Therapy and Outcomes: Immune, Inflammatory and Cardiovascular Effects in premenopausal, perimenopausal and postmenopausal women.

Bioidentical hormones are derived from plants. They are identical to the hormones a woman makes in her own body.

If you meet the following criteria, you may be eligible to participate in the C.H.O.I.I.C.E. research study:

Inclusion Criteria (All answers should be “yes”)

• Are you a female between the ages of 30 and 65?
• Do you agree to discontinue current hormone replacement therapy for a period of four weeks before entry into the study?
• Are you willing to commit to a three year time frame?
• Do you have access to email communications?
• If you are sexually active and fertile, do you agree to use the following non-hormonal contraception for the duration of the study: dual barrier method such as condoms and foam, or partner sterilization such as vasectomy?

Exclusion Criteria (All answers should be “no”)

• Are you pregnant or lactating?
• Do you have history of alcohol and drug abuse during the past two years?
• Have you been treated with any investigational drug within four weeks prior to entering the study?
• Do you have a history of drug sensitivity or food allergy that may interfere with the study?
• Are you taking any of the following medications:

- Prescription, synthetic, or naturally derived estrogen, proestrogen, DHEA or testosterone as a supplement or contraceptive.

- Steroids (oral or injectible within the last four weeks prior to the study).

- Anticoagulants, antibiotics or antibiotic treatment within the last four weeks prior to the study.

- Chronic us of COX-2 inhibitors.

- Cholesterol-lowering drugs. 

For additional information, please contact Janith Williams, assistant nursing professor and director of The Center for Excellence in Women’s Health Research and Outreach, at (903) 565.5649 or Dr. Kenna Stephenson, assistant professor of family medicine at The University of Texas Health Center at Tyler at (903) 565.1234.

Contact:
Lisa Buchanan
903-565-5769