NCT00361075

Brief Summary

The postmenopausal state is associated with an increase risk for heart disease. Much of this increase in risk may be due to the loss of estrogen (the main female hormone) and the effect of this loss on lipids (blood fats). This loss of estrogen is often treated by estrogen replacement therapy. Estrogen replacement therapy seems to have a beneficial effect on lipid levels. The purpose of this research study is to understand 1) how menopause affects lipids and 2) how hormone replacement therapy effects the lipid metabolism of postmenopausal women.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 1998

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

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

July 1, 1998

Completed
6.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 3, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 7, 2006

Completed
Last Updated

November 5, 2014

Status Verified

November 1, 2014

First QC Date

August 3, 2006

Last Update Submit

November 4, 2014

Conditions

MenopausePostmenopausePremenopauseCardiovascular Disease

Keywords

PerimenopauseAbdominal adipose tissueWomen's healthCholesterolLipid Metabolism

Outcome Measures

Primary Outcomes (1)

  • LDL particle size and density

Secondary Outcomes (5)

  • Total body adiposity (Dexa scans)

  • Intra-abdominal fat (CT scans)

  • Lipid Profile

  • Inflammatory Factors

  • Adipocytokines

Interventions

transdermal estradiol patch (Vivelle), oral estrogen (Estrace), progesterone (Prometrium)DRUG

Eligibility Criteria

Age47 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Have demonstrated an interest to participate in the ERT trial
  • Be premenopausal (have menstrual period in previous three months) prior to start of observational arm
  • Prior to start of interventional arm (ERT), the women must be postmenopausal (have not had a menstrual cycle in the past twelve months and FSH \>30)
  • Be between the ages of 47 and 55
  • Not be taking any form of estrogen replacement
  • Have an intact uterus and at least one ovary and normal screening mammogram in the 12 months prior to starting ERT

You may not qualify if:

  • Body mass index (kg/m2) greater than 40 kg/m2
  • History of diabetes mellitus or fasting \>110 mg/dl at screening
  • Abnormal fasting LDL or triglyceride
  • Use of lipid lowering medications, beta-blockers, birth control pills
  • Active liver disease (recent history of active hepatitis, jaundice, scleral icterus, and/or elevated liver function tests
  • History of breast, endometrial or ovarian cancer
  • History of thrombotic disorder (past history of pulmonary embolus or deep venous thrombosis) or known history of CAD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Northwestern University

Chicago, Illinois, 60611, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (2)

  • Carr MC, Hokanson JE, Deeb SS, Purnell JQ, Mitchell ES, Brunzell JD. A hepatic lipase gene promoter polymorphism attenuates the increase in hepatic lipase activity with increasing intra-abdominal fat in women. Arterioscler Thromb Vasc Biol. 1999 Nov;19(11):2701-7. doi: 10.1161/01.atv.19.11.2701.

    PMID: 10559014BACKGROUND

  • Carr MC, Kim KH, Zambon A, Mitchell ES, Woods NF, Casazza CP, Purnell JQ, Hokanson JE, Brunzell JD, Schwartz RS. Changes in LDL density across the menopausal transition. J Investig Med. 2000 Jul;48(4):245-50.

    PMID: 10916282BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

EstradiolEstrogensProgesterone

Intervention Hierarchy (Ancestors)

EstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesPregnenedionesPregnenesPregnanesCorpus Luteum HormonesProgesterone Congeners

Study Officials

  • Molly C. Carr, MD

    Northwestern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 3, 2006

First Posted

August 7, 2006

Study Start

July 1, 1998

Study Completion

May 1, 2005

Last Updated

November 5, 2014

Record last verified: 2014-11

Locations

US(2)