Estrogen, HDL, and Coronary Heart Disease in Women

NCT00083824 | Completed Phase 2

• 2 other identifiers: 1253R01HL070081
• Study Type: interventional
• Target: 309
• Locations: 1 country
• Sites: 1

Brief Summary

To clarify the effects of estrogen, with or without progestin, on high density lipoprotein (HDL) in postmenopausal women.

Conditions

Cardiovascular Diseases; Coronary Disease; Heart Diseases; Coronary Arteriosclerosis

Outcome Measures

Primary Outcomes (1)

• HDL subpopulation distribution and composition

  To assess the effect of hormonal replacement therapy on HDL subpopulation profile and HDL composition in postmenopausal women with established CHD

  1 year

Secondary Outcomes (1)

• Remnant lipoprotein cholesterol

  1 year

Study Arms (3)

Sugar Pill

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Estrogens, Conjugated (USP)

EXPERIMENTAL

Conjugated Equine Estrogen 0.625 mg/day for 3 years, drug

Drug: Estrogens, Conjugated (USP)

Medroxyprogesterone 17-acetate

EXPERIMENTAL

Conjugated Equine Estrogen 0.625 mg/day plus Medroxyprogesterone Acetate 2.5 mg/day

Drug: Estrogens, Conjugated (USP); Drug: Medroxyprogesterone 17-Acetate

Interventions

Estrogens, Conjugated (USP) DRUG

0.625 mg/day QID for 3 years

Also known as: Premarin

Estrogens, Conjugated (USP); Medroxyprogesterone 17-acetate

Medroxyprogesterone 17-Acetate DRUG

2.5 mg/day QID for 3 years

Also known as: Provera

Medroxyprogesterone 17-acetate

Placebo DRUG

2 pills/day QID for 3 years

Also known as: Sugar Pill

Sugar Pill

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age \>55 years without natural menses for at least 5 years or a serum FSH levels \>40 IU/L without natural menses for at least 1 y or bilateral oophorectomy documented coronary artery disease

You may not qualify if:

• history of breast or endometrial carcinoma history of deep-vein thrombosis or pulmonary embolism previous or planned coronary bypass gallstones fasting TG levels \>400 mg/dl uncontrolled diabetes uncontrolled hypertension serum creatinine \>2 mg/dl a \>70% stenosis of the left main coronary artery.

Sponsors & Collaborators

• Tufts University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

HNRCA at Tufts University

Boston, Massachusetts, 02111, United States

Location

Related Publications (5)

• Herrington DM, Reboussin DM, Brosnihan KB, Sharp PC, Shumaker SA, Snyder TE, Furberg CD, Kowalchuk GJ, Stuckey TD, Rogers WJ, Givens DH, Waters D. Effects of estrogen replacement on the progression of coronary-artery atherosclerosis. N Engl J Med. 2000 Aug 24;343(8):522-9. doi: 10.1056/NEJM200008243430801.

  PMID: 10954759 BACKGROUND

• Lamon-Fava S, Herrington DM, Reboussin DM, Sherman M, Horvath K, Schaefer EJ, Asztalos BF. Changes in remnant and high-density lipoproteins associated with hormone therapy and progression of coronary artery disease in postmenopausal women. Atherosclerosis. 2009 Jul;205(1):325-30. doi: 10.1016/j.atherosclerosis.2008.12.020. Epub 2008 Dec 24.

  PMID: 19155011 RESULT

• Lamon-Fava S, Herrington DM, Reboussin DM, Sherman M, Horvath KV, Cupples LA, White C, Demissie S, Schaefer EJ, Asztalos BF. Plasma levels of HDL subpopulations and remnant lipoproteins predict the extent of angiographically-defined coronary artery disease in postmenopausal women. Arterioscler Thromb Vasc Biol. 2008 Mar;28(3):575-9. doi: 10.1161/ATVBAHA.107.157123. Epub 2008 Jan 3.

  PMID: 18174456 RESULT

• Lamon-Fava S, Asztalos BF, Howard TD, Reboussin DM, Horvath KV, Schaefer EJ, Herrington DM. Association of polymorphisms in genes involved in lipoprotein metabolism with plasma concentrations of remnant lipoproteins and HDL subpopulations before and after hormone therapy in postmenopausal women. Clin Endocrinol (Oxf). 2010 Feb;72(2):169-75. doi: 10.1111/j.1365-2265.2009.03644.x. Epub 2009 May 29.

  PMID: 19489872 RESULT

• Lamon-Fava S, Herrington DM, Horvath KV, Schaefer EJ, Asztalos BF. Effect of hormone replacement therapy on plasma lipoprotein levels and coronary atherosclerosis progression in postmenopausal women according to type 2 diabetes mellitus status. Metabolism. 2010 Dec;59(12):1794-800. doi: 10.1016/j.metabol.2010.05.012. Epub 2010 Jun 26.

  PMID: 20580029 RESULT

MeSH Terms

Conditions

Cardiovascular Diseases; Coronary Disease; Heart Diseases; Coronary Artery Disease

Interventions

Estrogens, Conjugated (USP); Medroxyprogesterone Acetate; Sugars

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Medroxyprogesterone; Hydroxyprogesterones; Progesterone; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Carbohydrates

Study Officials

• Stefania Lamon-Fava

  Tufts University

  PRINCIPAL INVESTIGATOR

• David M Herrington, MD

  Wake Forest University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 2, 2004
• First Posted: June 4, 2004
• Study Start: March 1, 2004
• Primary Completion: February 1, 2007
• Study Completion: February 1, 2007
• Last Updated: April 21, 2016

Record last verified: 2016-04

Locations

US (1)