Trial record 16 of 97 for:    estrogen replacement therapy

Kronos Early Estrogen Prevention Study (KEEPS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Kronos Longevity Research Institute.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Albert Einstein College of Medicine of Yeshiva University
Brigham and Women's Hospital
Columbia University
Mayo Clinic
University of California, San Francisco
University of Utah
University of Washington
Yale University
Information provided by:
Kronos Longevity Research Institute
ClinicalTrials.gov Identifier:
NCT00154180
First received: September 7, 2005
Last updated: September 10, 2009
Last verified: September 2009
  Purpose

The study will examine the effects of estrogen and progesterone on the development of atherosclerosis in menopausal women when hormone treatment is initiated within 3 years of the menopausal transition.


Condition Intervention Phase
Menopause
Arteriosclerosis
Drug: Conjugated equine estrogens 0.45 mg/day
Drug: Transdermal estradiol, 50 mcg/day
Drug: Micronized progesterone, 200 mg/day x 12 d/month
Drug: CEE , progesterone, estradiol patch or placebo for each
Drug: CEE, progesterone, transdermal patch or the placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Effects of Estrogen Replacement on Atherosclerosis Progression in Recently Menopausal Women

Resource links provided by NLM:


Further study details as provided by Kronos Longevity Research Institute:

Primary Outcome Measures:
  • Rate of change of carotid intimal medial thickness by ultrasound [ Time Frame: Measured at screening, 12, 24, 36, and 48 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in coronary calcium score by X-ray tomography [ Time Frame: Meassured at screening and at 48 months ] [ Designated as safety issue: No ]
  • Plasma lipid profiles [ Time Frame: Samples taken at screening , 12, 36, and 48 months ] [ Designated as safety issue: No ]
  • Blood clotting factors [ Time Frame: Samples taken at screening, 12, 36 and 48 months ] [ Designated as safety issue: No ]
  • Serum inflammatory factors [ Time Frame: Samples taken at screening, 12, 36 and 48 months ] [ Designated as safety issue: No ]
  • Hormone levels [ Time Frame: Samples taken at screening, 12, 36 and 48 months ] [ Designated as safety issue: No ]
  • Cognitive and Affective scores on standard psychometric tests [ Time Frame: Testing is conducted at Baseline, 18, 36 and 48 months ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: Measured at Baseline, 18, 36 and 48 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 728
Study Start Date: September 2005
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1
CEE 0.45 mg w/ Prometrium 200 mg patch 0.05 mg w/ Prometrium 200 mg
Drug: Conjugated equine estrogens 0.45 mg/day
Pill, 1 pill taken daily each month for the study duration
Other Name: Premarin or placebo
Drug: Transdermal estradiol, 50 mcg/day
Patch; 1 patch is applied to the skin weekly. Patch site is rotated on a weekly basis.
Other Name: Climara 50 mcg/day or placebo
Drug: Micronized progesterone, 200 mg/day x 12 d/month
capsule, 1 capsule taken daily for the first 12 days of each month for the study duration
Other Name: Prometrium or placebo
Drug: CEE, progesterone, transdermal patch or the placebo
CEE 0.45 mg 1 PO QD or placebo equivalent Prometrium 200 mg 1 PO qHS for first 12 dasy of each month or placebo equivalent transdermal patch 0.05 mg use 1 patch per week or placebo equivalent
Other Names:
  • Premarin
  • Prometrium
  • Climara
Placebo Comparator: Arm 2
Placebo patch, placebo CEE, placebo Prometrium
Drug: CEE , progesterone, estradiol patch or placebo for each
CEE 0.45mg 1 PO QD Progesterone 200 mg 1 PO HS first 12 days of the month estradiol patch use 1 per week
Other Names:
  • Premarin
  • Prometrium
  • Climara Patch
Drug: CEE, progesterone, transdermal patch or the placebo
CEE 0.45 mg 1 PO QD or placebo equivalent Prometrium 200 mg 1 PO qHS for first 12 dasy of each month or placebo equivalent transdermal patch 0.05 mg use 1 patch per week or placebo equivalent
Other Names:
  • Premarin
  • Prometrium
  • Climara

Detailed Description:

The KEEPS is designed to explore the hypothesis that early initiation of hormone therapy, in women who are at the inception of their menopause, will decrease the rate of accumulation of atherosclerotic plaque, indicating a likely delay in the onset of clinical cardiovascular disease. The study is designed as a multicenter, 4 year randomized clinical trial. It will evaluate the effectiveness of of 0.45 mg/day of oral conjugated equine estrogens or 50 mcg/day of transdermal estradiol via skin patch changed weekly (each in combination with cyclic oral, micronized progesterone, 200 mg daily for 12 days per month), versus placebo in preventing progression of carotid intimal medial thickness by sonogram and the accrual of coronary calcium in women aged 42-58 who are within 36 months of their final menstrual period at initiation of treatment. A number of secondary endpoints including biochemical and genetic risk factors for cardiovascular and thrombotic disease, and effects on cognition will also be studied. The study will enroll a total of 720 women in 2005-6, with an anticipated completion of the trial in 2010.

  Eligibility

Ages Eligible for Study:   42 Years to 58 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • menses absent for at least 6 months and no more than 36 months
  • good general health
  • plasma FSH level greater than or equal to 35 mIU/ml
  • estradiol levels < 40 pg/ml
  • normal mammogram within 1 year of randomization

Exclusion Criteria:

  • use of hormone replacement or supplement within 3 months of randomization
  • endometrial thickness >5 mm by vaginal ultrasound
  • in utero exposure to diethylstilbestrol (DES)
  • current smoking > 10 cigarettes/day
  • obesity-body mass index > 35
  • history of clinical cardiovascular disease
  • history of cerebrovascular disease
  • history of thromboembolic disease
  • coronary calcium score ≥ 50 units
  • dyslipidemia-LDL cholesterol >190 mg/dl
  • hypertriglyceridemia-triglycerides >400 mg/dl
  • lipid lowering medication (statin, fibrate,or > 500 mg/day of niacin)
  • nut allergy (Prometrium includes peanut oil)
  • uncontrolled hypertension-systolic BP >150 and/or diastolic BP > 95
  • hysterectomy
  • history of, or prevalent, chronic diseases including any cancer (other than basal cell skin cancers), renal failure, cirrhosis, diabetes mellitus, and endocrinopathies other than adequately treated thyroid disease
  • known HIV infection and/or medications for HIV infection
  • results of any safety laboratory test chemistries, (TSH, CBC, U/A) more than 20% abnormal
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00154180

Locations
United States, Arizona
Kronos Longevity Research Institute
Phoenix, Arizona, United States, 85016-3452
United States, California
University of California, San Francisco
San Francisco, California, United States, 94115
United States, Connecticut
Yale University Medical Center
New Haven, Connecticut, United States, 06519
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02215
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New York
Albert Einstein College of Medicine
Bronx, New York, United States, 10461
Columbia Presbyterian Hospital
New York, New York, United States, 10032
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84108
United States, Washington
University of Washington/VA Puget Sound, HCS
Seattle/Tacoma, Washington, United States, 98493
Sponsors and Collaborators
Kronos Longevity Research Institute
Albert Einstein College of Medicine of Yeshiva University
Brigham and Women's Hospital
Columbia University
Mayo Clinic
University of California, San Francisco
University of Utah
University of Washington
Yale University
Investigators
Study Director: S Mitchell Harman, MD, PhD Kronos Longevity Research Institute
Study Director: Frederick Naftolin, MD, PhD Kronos Longevity Research Institute
Principal Investigator: Michael Mendelsohn, MD Tufts Medical Center
Principal Investigator: Howard Hodis, MD University of Southern California
Principal Investigator: Matthew Budoff, MD University of California, Los Angeles
Principal Investigator: Sanjay Asthana, MD University of Wisconsin, Madison
Principal Investigator: Dennis M Black, PhD University of California, San Francisco
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: S. Mitchell Harman, MD, PhD/Director, Kronos Longevity Research Institute
ClinicalTrials.gov Identifier: NCT00154180     History of Changes
Other Study ID Numbers: KLRI-04-1, WIRB Protocol #20040792
Study First Received: September 7, 2005
Last Updated: September 10, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Kronos Longevity Research Institute:
Perimenopause
Coronary Disease
Estrogen Replacement Therapy
Hormone Replacement Therapy

Additional relevant MeSH terms:
Estrogens, Conjugated (USP)
Estrogens
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Estradiol
Polyestradiol phosphate
Progesterone
Estradiol valerate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptive Agents, Female
Progestins

ClinicalTrials.gov processed this record on July 24, 2014