Estrogen Alternatives Study

This study has been completed.
Sponsor:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00108238
First received: April 14, 2005
Last updated: January 20, 2009
Last verified: April 2007

April 14, 2005
January 20, 2009
April 2003
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Complete list of historical versions of study NCT00108238 on ClinicalTrials.gov Archive Site
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Estrogen Alternatives Study
Estrogen Alternatives and Vascular Function in Post-Menopausal Women

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.

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Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Healthy
  • Drug: Estradiol followed by progesterone
  • Drug: Raloxifene
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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December 2006
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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
Female
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Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00108238
CLIN-001-02F
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Department of Veterans Affairs
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Principal Investigator: Claire Duvernoy, M.D.
Department of Veterans Affairs
April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP