NCT00108238

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Apr 2003

Longer than P75 for phase_4 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

April 14, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 15, 2005

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

January 21, 2009

Status Verified

April 1, 2007

First QC Date

April 14, 2005

Last Update Submit

January 20, 2009

Conditions

Healthy

Keywords

endothelial functionhormone replacement therapycoronary flow reserveposmenopausal womenwomen's cardiovascular heatlh

Interventions

Estradiol followed by progesteroneDRUG
RaloxifeneDRUG

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Ann Arbor Healthcare System

Ann Arbor, Michigan, 48105, United States

Location

MeSH Terms

Interventions

Raloxifene Hydrochloride

Intervention Hierarchy (Ancestors)

TamoxifenStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Claire Duvernoy, M.D.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
FED

Study Record Dates

First Submitted

April 14, 2005

First Posted

April 15, 2005

Study Start

April 1, 2003

Study Completion

December 1, 2006

Last Updated

January 21, 2009

Record last verified: 2007-04

Locations

US(1)