NCT00115024

Brief Summary

The purpose of this study is to determine the effects of estrogen replacement therapy (ERT) on the progression of early atherosclerosis in healthy postmenopausal women without preexisting cardiovascular disease (CVD).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
222

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 1994

Typical duration for phase_2

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 1994

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 1998

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 1998

Completed
6.6 years until next milestone

First Submitted

Initial submission to the registry

June 20, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 21, 2005

Completed
Last Updated

December 11, 2009

Status Verified

June 1, 2005

Enrollment Period

4.6 years

First QC Date

June 20, 2005

Last Update Submit

December 9, 2009

Conditions

AtherosclerosisPostmenopause

Keywords

cardiovascular diseaseCVDestrogencholesterolLDLlipidspostmenopausal

Outcome Measures

Primary Outcomes (1)

  • rate of change of distal common carotid artery (CCA) far wall intima-media thickness (IMT)

Secondary Outcomes (1)

  • lipid and non-lipid factors

Interventions

Micronized 17B-estradiolDRUG

Eligibility Criteria

Age46 Years - 80 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Postmenopausal female (serum estradiol less than 20 pg/ml)
  • to 80 years old
  • Fasting LDL-C levels 130 to 210 mg/dL
  • Triglyceride levels less than 400 mg/dL
  • Current non-smoker

You may not qualify if:

  • Clinical evidence of cardiovascular disease
  • HDL-C level less than 30 mg/dL
  • Fasting blood glucose greater than 200 mg/dL
  • Previous hormonal replacement therapy (non-contraceptive) over 10 years duration and/or current use within 1 month
  • Uncontrolled hypertension
  • Untreated thyroid disease
  • Renal insufficiency
  • Clinical evidence of congestive heart failure
  • Life threatening disease with prognosis less than 5 years
  • Alcohol intake greater than 5 drinks per day (1 drink = 1 1/2 oz distilled spirits, 4 oz wine, or 12 oz beer) or substance abuse (intravenous drug abuse, cocaine use)
  • History of estrogen dependent cancer or detected at screening or any other disorder precluding use of ERT
  • Hot flashes greater than 5 per day which interfere with daily activity and preclude randomization to placebo.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atherosclerosis Research Unit, Division of Cardiovascular Medicine, Department of Medicine

Los Angeles, California, 90033, United States

Location

Related Publications (2)

  • Hodis HN, Mack WJ, Lobo RA, Shoupe D, Sevanian A, Mahrer PR, Selzer RH, Liu Cr CR, Liu Ch CH, Azen SP; Estrogen in the Prevention of Atherosclerosis Trial Research Group. Estrogen in the prevention of atherosclerosis. A randomized, double-blind, placebo-controlled trial. Ann Intern Med. 2001 Dec 4;135(11):939-53. doi: 10.7326/0003-4819-135-11-200112040-00005.

    PMID: 11730394RESULT

  • Steiner AZ, Xiang M, Mack WJ, Shoupe D, Felix JC, Lobo RA, Hodis HN. Unopposed estradiol therapy in postmenopausal women: results from two randomized trials. Obstet Gynecol. 2007 Mar;109(3):581-7. doi: 10.1097/01.AOG.0000251518.56369.eb.

    PMID: 17329508DERIVED

MeSH Terms

Conditions

AtherosclerosisCardiovascular Diseases

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Howard N. Hodis, MD

    University of Southern California, Atherosclerosis Research Unit, Division of Cardiovascular Medicine, Department of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

June 20, 2005

First Posted

June 21, 2005

Study Start

April 1, 1994

Primary Completion

November 1, 1998

Study Completion

November 1, 1998

Last Updated

December 11, 2009

Record last verified: 2005-06

Locations

US(1)