Estrogen Alternatives Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Study Completion Date

2006-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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Estradiol followed by progesterone

Intervention Type DRUG

Raloxifene

Intervention Type DRUG

Eligibility Criteria

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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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes