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Estrogen Alternatives Study

This study has been completed.
Information provided by:
VA Office of Research and Development Identifier:
First received: April 14, 2005
Last updated: January 20, 2009
Last verified: April 2007
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.

Condition Intervention Phase
Healthy Drug: Estradiol followed by progesterone Drug: Raloxifene Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Estrogen Alternatives and Vascular Function in Post-Menopausal Women

Further study details as provided by VA Office of Research and Development:

Study Start Date: April 2003
Estimated Study Completion Date: December 2006

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00108238

United States, Michigan
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, United States, 48105
Sponsors and Collaborators
VA Office of Research and Development
Principal Investigator: Claire Duvernoy, M.D.
  More Information Identifier: NCT00108238     History of Changes
Other Study ID Numbers: CLIN-001-02F
Study First Received: April 14, 2005
Last Updated: January 20, 2009

Keywords provided by VA Office of Research and Development:
endothelial function
hormone replacement therapy
coronary flow reserve
posmenopausal women
women's cardiovascular heatlh

Additional relevant MeSH terms:
Raloxifene Hydrochloride
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Estrogen Antagonists
Hormone Antagonists
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents processed this record on September 19, 2017