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Sex Hormones and Atherosclerosis Prevention in Perimenopausal Women

NCT00608062 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 155

Last updated 2020-12-24

Study results available
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Summary

The purpose of this study is to find out why women's arteries stiffen as they go through menopause, and how this is affected by estrogen loss. We believe that arteries stiffen with the loss of estrogen because of "oxidative stress," the production of molecules that can damage cells and tissues in the body, and because the arteries lose their ability to expand, or dilate.

Conditions

Interventions

DRUG

GnRHant - Ganirelix acetate

1 subcutaneous injection at 0.5 mg then daily injections of 0.25 mg for 6 days (total of 7 days of injections); testing will occur on injection day 4 and day 7

DRUG

Transdermal estradiol patch

0.075mg/d starting on day 4 of the injections following testing time point two; continue for 3 days and retest (day 7)

DRUG

Transdermal placebo patch

Starting on day 4 of the injections following testing time point two; continue for 3 days and retest (day 7)

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Kerrie L Moreau, PhD · University of Colorado, Denver

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2012-10-25
Completion
2012-10-25

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00608062 on ClinicalTrials.gov