KEEPS Cognitive and Affective Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by University of Wisconsin, Madison.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
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
First received: February 14, 2008
Last updated: September 27, 2010
Last verified: September 2010
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: KEEPS Cognitive and Affective Study

Resource links provided by NLM:


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
Active Comparator: 1
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
Active Comparator: 2
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
Placebo Comparator: 3
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
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: 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
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
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:
No publications provided

Responsible Party: Sanjay Asthana MD, UW Wisconsin, Madison, WI
ClinicalTrials.gov Identifier: NCT00623311     History of Changes
Other Study ID Numbers: R01AG029624, R01AG029624
Study First Received: February 14, 2008
Last Updated: September 27, 2010
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

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

ClinicalTrials.gov processed this record on July 22, 2014