Research

The following research studies are currently being conducted in the Program in Integrative Medicine. 
If you are interested in participating, please call 913-588-6104 to leave your contact information.  A study representative will contact you shortly.

Evaluation of Bioidentical Hormones in Early Menopause

Now Recruiting

http://www.clinicaltrials.gov/ct/show/NCT00302731?order=1

This pilot study is designed as a prospective double blind, placebo controlled study comparing 4 groups of women who are within 7 years of menopause. There will be 10 women in each of the 4 groups with a total of 40 women enrolled and these women will be treated for 12 months.

The Long-Term Goal is to provide health care practitioners and consumers with evidence-based recommendations for the use of bioidentical hormone replacement.

The Short-Term Goal of this pilot study is to provide safety information for bioidentical hormone use by evaluating surrogate markers for cardiovascular disease (lipid levels), with secondary evaluation of breast (mammogram) and uterus (endovaginal ultrasound), and to collect information about bone preservation.

The Hypothesis is: bioidentical hormone replacement therapy provides a safe alternative to standard hormone replacement therapy.

To test this hypothesis the following Specific Aim has been identified:  To determine if bioidentical hormone replacement therapy is associated with improved lipid profiles (surrogate marker for cardiovascular disease) when compared to Prempro. This will be determined by evaluating lipid levels at baseline and during the 12-month treatment period.

Inclusion Criteria:

• Female
• Ambulatory
• Within 7 years post menopause
• Positive history of menopausal symptoms such as vasomotor symptoms or osteoporosis in a study subject unable to tolerate bisphosphonates
• FSH greater than 20 mIU/mL
• Intact uterus and at least one intact ovary
• Amenorrhea for 3 months or greater up to 7 years
• Normal pap smear results within 12 months
• Normal mammogram result within 12 months
• Agreeable to a 3 month washout period with no hormones prior to entering the trial
• Women who have no language barrier, are cooperative, and who can give informed consent before entering this study

Exclusion Criteria:

• Unwilling to take hormone replacement for the 12 month period
• Evidence of clinically significant psychiatric disorder by history/examination that would prevent the patient from completing the study.
• Active deep venous thrombosis, pulmonary embolism, or a history of these conditions
• Active or recent arterial thromboembolic disease
• Undiagnosed vaginal bleeding
• Hypersensitivity to ingredients in Prempro
• Patients with known current bone disorders other than primary osteoporosis
• Patients with pathological fractures
• Patients with suspected or history of carcinoma of the breast or estrogen dependent neoplasms such as endometrial carcinoma.
• Patients who have ≥ 5mm endometrial thickness by endovaginal (transvaginal) ultrasound.
• Patients who have impaired renal function evidenced by serum creatinine greater than 2.5 mg/dL.
• Patients who have impaired hepatic function evidenced by transaminase (AST/ALT) ≥2.5X upper limit
• Patients with severe malabsorption syndromes.
• Patients who consume an excess of alcohol or abuse drugs (an excess of alcohol is defined as more than four of any one or combination of the following per day: 30 mL distilled spirits, 340 mL beer, or 120 mL wine).
• Patients who received any investigational drug within the proceeding month
• tobacco use will not be allowed
• Treatment with therapeutic doses of any of the following medications more recently than 3 months:
• Estrogen
• Callcitonin
• Progestins
• Androgen
• SERMS
• Bisphosphonates
• Corticosteroids
• Progesterone
• Lithium
• Heparin
• Fluorides
• Vitamin D - 50,000IU
• Anticonvulsants
• Herbal menopause treatments
• Phosphate binding antacids