KEEPS Cognitive and Affective Study - Full Text View

Sponsors and Collaborators:	University of Wisconsin, Madison Kronos Longevity Research Institute University of Utah University of California Albert Einstein College of Medicine of Yeshiva University Brigham and Women's Hospital Columbia University Mayo Clinic University of Washington Yale University
Information provided by:	University of Wisconsin, Madison
ClinicalTrials.gov Identifier:	NCT00623311

Purpose

The KEEPS Cognitive and Affective Study is a multi-center clinical trial investigating the potential benefits of menopausal hormone therapies administered to perimenopausal women. The UW investigators are serving as consultants for a cognitive substudy offered to enrollees of the Kronos Early Estrogen Prevention Study (KEEPS).

See NCT00154180

Condition	Intervention	Phase
Perimenopause Coronary Disease Estrogen Replacement Therapy Hormone Replacement Therapy	Drug: oral conjugated equine estrogens Drug: transdermal estradiol Drug: micronized progesterone Other: Placebo	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	KEEPS Cognitive and Affective Study

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Disease Hormone Replacement Therapy Memory

Drug Information available for: Estradiol Estradiol 3-benzoate Progesterone Polyestradiol phosphate Depogen Estradiol dipropionate Estradiol cypionate Estradiol valerate Estradiol acetate

U.S. FDA Resources

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:

The primary outcome measures are performance on tests of verbal memory and attention/executive function. [ Time Frame: every 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Secondary outcome measures will include performance variables on other tests of cognition, total scores on measures of affect and memory complaints, and evaluation of the influence of ApoE genotype on an individual's responsivity to HT. [ Time Frame: every 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	720
Study Start Date:	May 2007
Estimated Study Completion Date:	April 2012
Estimated Primary Completion Date:	April 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 0.45 mg/day of oral conjugated equine estrogens in combination with cyclic oral, micronized progesterone, 200 mg daily for 12 days per month	Drug: oral conjugated equine estrogens 0.45 mg/day of oral conjugated equine estrogens Drug: micronized progesterone cyclic oral, micronized progesterone, 200 mg daily for 12 days per month
2: Active Comparator 50 mcg/day of transdermal estradiol via skin patch changed weekly in combination with cyclic oral, micronized progesterone, 200 mg daily for 12 days per month	Drug: transdermal estradiol 50 mcg/day of transdermal estradiol via skin patch changed weekly Drug: micronized progesterone cyclic oral, micronized progesterone, 200 mg daily for 12 days per month
3: Placebo Comparator Placebo	Other: Placebo Placebo Patch and Tablet

Detailed Description:

The Kronos Early Estrogen Prevention Study (KEEPS) is a multi-center clinical trial investigating the potential benefits of menopausal hormone therapies (MHTs) administered to perimenopausal women. The UW investigators are serving as consultants for a cognitive substudy examining the effect of MHT on cognitive function, and hypothesizes that women receiving MHT will performed better than women on placebo.

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00623311

Locations

United States, Arizona
Kronos Longevity Research Institute
Phoenix, Arizona, United States, 85016
United States, California
University of California
San Francisco, California, United States, 94115
United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06520
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
Columbia Presbyterian Hospital
New York, New York, United States, 10032
Albert Einstein College of Medicine
Bronx, New York, United States, 10461
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
United States, Wisconsin
University of Wisconsin Madison
Madison, Wisconsin, United States, 53792

Sponsors and Collaborators

University of Wisconsin, Madison

Kronos Longevity Research Institute

University of Utah

University of California

Albert Einstein College of Medicine of Yeshiva University

Brigham and Women's Hospital

Columbia University

Mayo Clinic

University of Washington

Yale University

Investigators

Principal Investigator:	Eliot Brinton, MD	University of Utah
Principal Investigator:	Marcelle Cedars, MD	University of California at San Francisco
Principal Investigator:	JoAnn Manson, MD, Dr. PH	Brigham and Women's Hospital
Principal Investigator:	Virginia Miller, PhD, MBA	Mayo Clinic
Principal Investigator:	Rogerio Lobo, MD	Columbia University College of Physicians and Surgeons
Principal Investigator:	George Merriam, MD, PhD	University of Washington
Principal Investigator:	Hugh Taylor, MD	Yale School of Medicine
Principal Investigator:	Nanette Santoro, MD	Montefiore Medical Center
Principal Investigator:	S. Mitchell Harman, MD, PhD	Kronos Longevity Research Institute
Principal Investigator:	Sanjay Asthana, MD	Univerisity of Wisconsin - Madison

More Information

Additional Information:

Wisconsin Comprehensive Memory Program This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	UW Wisconsin, Madison, WI ( Sanjay Asthana MD )
Study ID Numbers:	R01AG029624, R01AG029624
Study First Received:	February 14, 2008
Last Updated:	November 8, 2008
ClinicalTrials.gov Identifier:	NCT00623311 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:

Estrogens
Progestins
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists

Cardiovascular Diseases
Hormones
Pharmacologic Actions

Study placed in the following topic categories:

Arterial Occlusive Diseases
Estrogens
Heart Diseases
Progesterone
Hormone Antagonists
Myocardial Ischemia
Estradiol valerate
Hormones, Hormone Substitutes, and Hormone Antagonists
Vascular Diseases
Ischemia

Arteriosclerosis
Estradiol 17 beta-cypionate
Hormones
Estradiol
Coronary Disease
Estrogens, Conjugated (USP)
Progestins
Estradiol 3-benzoate
Polyestradiol phosphate
Coronary Artery Disease

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Estrogens
Heart Diseases
Progesterone
Myocardial Ischemia
Physiological Effects of Drugs
Vascular Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Arteriosclerosis

Hormones
Pharmacologic Actions
Estradiol
Coronary Disease
Estrogens, Conjugated (USP)
Progestins
Cardiovascular Diseases
Coronary Artery Disease

ClinicalTrials.gov processed this record on September 03, 2009