Estrogen Alternatives Study

This study has been completed.

First Received on April 14, 2005. Last Updated on January 20, 2009 History of Changes

Sponsor:	Department of Veterans Affairs
Information provided by:	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00108238

Purpose

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 IV

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

Resource links provided by NLM:

MedlinePlus related topics: Hormone Replacement Therapy

Drug Information available for: Estradiol Estradiol 3-benzoate Progesterone Polyestradiol phosphate Depogen Raloxifene hydrochloride Raloxifene Estradiol dipropionate Estradiol cypionate Estradiol valerate Estradiol acetate

U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

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

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00108238

Locations

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

Sponsors and Collaborators

Department of Veterans Affairs

Investigators

Principal Investigator:

Claire Duvernoy, M.D.

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00108238 History of Changes
Other Study ID Numbers:	CLIN-001-02F
Study First Received:	April 14, 2005
Last Updated:	January 20, 2009
Health Authority:	United States: Federal Government

Keywords provided by Department of Veterans Affairs:

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

Additional relevant MeSH terms:

Estradiol
Estrogens
Progesterone
Raloxifene
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

Pharmacologic Actions
Progestins
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Hormone Antagonists
Bone Density Conservation Agents
Estrogen Antagonists

ClinicalTrials.gov processed this record on February 09, 2012