Estrogen Alternatives Study
Information source: Department of Veterans Affairs
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Estradiol followed by progesterone (Drug); Raloxifene (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Department of Veterans Affairs Official(s) and/or principal investigator(s):
Claire Duvernoy, M.D., Principal Investigator
Summary
Healthy postmenopausal women not currently taking hormone replacement or hormone modulating
therapy take a 3-month course of estradiol/raloxifene/placebo to evaluate the effects of each
on vascular function, as indicated by PET coronary flow reserve studies and brachial artery
ultrasound, before and after use of the therapies. This is a randomized, placebo-controlled,
blinded study.
Clinical Details
Official title: Estrogen Alternatives and Vascular Function in Post-Menopausal Women
Study design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Postmenopausal women (no menses for greater than or equal to 12 months, or s/p [status
post] hysterectomy with bilateral ovariectomy) not currently taking hormone
replacement therapy (within previous 3 months)
- Normal mammogram within previous 12 months
Exclusion Criteria:
- Current or recent (within previous 3 months) hormone replacement therapy
- Current or recent (within previous 3 months) use of hormone alternatives such as
raloxifene, tamoxifen, or soy estrogen preparations.
- LDL Cholesterol > 160 mg/dl.
- History of hypertension, diabetes mellitus, peripheral vascular disease,
cerebrovascular disease, current smoking, history of DVT (deep vein thrombosis) or PE
(pulmonary embolism), active gallbladder disease, family history of premature (men
under 55 yrs, women under 65 yrs) coronary artery disease
- History of breast, uterine, or ovarian cancer Contraindication to adenosine
administration (i. e., significant bronchospastic pulmonary disease, higher degree
heart block)
- Inability to give informed consent
- Inability to temporarily (for 24 hours) discontinue potential vasoactive drugs, such
as anti-inflammatory agents and aspirin, at least 24 hours prior to the examinations.
- History of coronary heart disease
Locations and Contacts
VA Ann Arbor Healthcare System, Ann Arbor, Michigan 48105, United States
Additional Information
Starting date: April 2003
Ending date: December 2006
Last updated: April 30, 2007
|
