Estrogen Alternatives Study (NCT00108238)

Study 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.

Conditions studied

Healthy

Keywords

endothelial function
hormone replacement therapy
coronary flow reserve
posmenopausal women
women's cardiovascular heatlh

In context

Lead sponsor

US Department of Veterans Affairs is the lead sponsor of 658 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible: 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

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

Study design

Phase: Phase 4
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double

Interventions

DrugEstradiol followed by progesterone
DrugRaloxifene

Study locations

1 site

VA Ann Arbor Healthcare System
Ann Arbor, Michigan 48105, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 21, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00108238
Lead sponsor: US Department of Veterans Affairs
First posted: Apr 15, 2005
Start date: Apr 2003
Completion: Dec 2006
Last update: Jan 21, 2009

Study contacts

Claire Duvernoy, M.D.

principal investigator

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2007. You cannot join it, but the record below documents what was studied.

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Discussion

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Estrogen Alternatives Study