Trial record 1 of 1627 for:    KEEPS
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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

February 14, 2008
September 27, 2010
May 2007
April 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00623311 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
KEEPS Cognitive and Affective Study
KEEPS Cognitive and Affective Study

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

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Perimenopause
  • Coronary Disease
  • Estrogen Replacement Therapy
  • Hormone Replacement Therapy
  • Drug: oral conjugated equine estrogens
    0.45 mg/day of oral conjugated equine estrogens
  • 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
  • Other: Placebo
    Placebo Patch and Tablet
  • 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
    Interventions:
    • Drug: oral conjugated equine estrogens
    • Drug: micronized progesterone
  • 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
    Interventions:
    • Drug: transdermal estradiol
    • Drug: micronized progesterone
  • Placebo Comparator: 3
    Placebo
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
720
April 2012
April 2012   (final data collection date for primary outcome measure)

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
Female
42 Years to 58 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00623311
R01AG029624, R01AG029624
Yes
Sanjay Asthana MD, UW Wisconsin, Madison, WI
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
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
University of Wisconsin, Madison
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP