Status:
TERMINATED
Bioidentical 'Natural' Hormone Evaluation in Early Menopause
Lead Sponsor:
Jeanne Drisko, MD, CNS, FACN
Collaborating Sponsors:
Private Foundation through KU Endowment
University of Kansas
Conditions:
Menopause
Eligibility:
FEMALE
40-65 years
Phase:
PHASE2
Brief Summary
Prospective double blind pilot study comparing bioidentical 'natural' hormones to low-dose PremPro. Forty participants will be enrolled. The purpose of this study is to try to gather early information...
Detailed Description
In spite of warnings regarding safety and adverse events widely publicized after the Women's Health Initiative (WHI), women continue to seek hormone replacement therapy for a variety of reasons. Incre...
Eligibility Criteria
Inclusion
- 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
- 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).
- Treatment with therapeutic doses of any of the following medications more recently than 3 months:
- Estrogen
- Calcitonin
- Corticosteroids
- Progestins
- Progesterone
- Lithium
- Androgen
- Heparin
- Herbal menopause treatments
- SERMS
- Fluorides
- Phosphate binding antacids
- Bisphosphonates
- Vitamin D 50,000IU
- Anticonvulsants
- Patients who received any investigational drug within the proceeding month
- Tobacco use will not be allowed
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00302731
Start Date
February 1 2006
End Date
September 1 2014
Last Update
July 6 2018
Active Locations (1)
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1
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160