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Estrogen, Diabetes, and Endothelial Function

NCT04418908 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2020-06-05

No results posted yet for this study

Summary

This study planned to learn more about women and how the drop in estradiol levels during menopause may affect their cardiovascular risk. With aging, the arteries that are located around the heart get stiffer, and this increase in arterial stiffness can lead to a number of health problems such as high blood pressure and heart disease. In this study, the investigators examined whether a short-term drop in estrogen levels caused arteries to become stiffer, and explored potential reasons for stiffening arteries.

Conditions

Interventions

DRUG

Cetrorelix acetate, 0.25 mg/day

All participants self-administered GnRHant daily between the baseline and follow-up visits (cetrorelix acetate, 0.25 mg/day).

DRUG

Estradiol Patch, 0.025 Mg/24 Hours Weekly Transdermal Film, Extended Release

Active estradiol transdermal patch.

DRUG

Placebo patch

Placebo patch designed to match active Climara patches.

Sponsors & Collaborators

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Janet K Snell-Bergeon, PhD, MPH · University of Colorado, Denver

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-11-24
Primary Completion
2018-10-22
Completion
2018-10-22

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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 NCT04418908 on ClinicalTrials.gov