Trial record 1 of 1297 for: KEEPS

Previous Study | Return to List | Next Study

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

History of Changes

Tracking Information

First Received Date ^ICMJE

February 14, 2008

Last Updated Date

September 27, 2010

Start Date ^ICMJE

May 2007

Estimated Primary Completion Date

April 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00623311 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

KEEPS Cognitive and Affective Study

Official Title ^ICMJE

KEEPS Cognitive and Affective Study

Brief Summary

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Perimenopause
Coronary Disease
Estrogen Replacement Therapy
Hormone Replacement Therapy

Intervention ^ICMJE

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

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

720

Estimated Completion Date

April 2012

Estimated Primary Completion Date

April 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

42 Years to 58 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00623311

Other Study ID Numbers ^ICMJE

R01AG029624, R01AG029624

Has Data Monitoring Committee

Yes

Responsible Party

Sanjay Asthana MD, UW Wisconsin, Madison, WI

Study Sponsor ^ICMJE

University of Wisconsin, Madison

Collaborators ^ICMJE

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 ^ICMJE

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

Information Provided By

University of Wisconsin, Madison

Verification Date

September 2010

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

To Top