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
Recruitment status was Active, not recruiting
Sponsor:
University of Wisconsin, Madison
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
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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:
Drug Information available for:
Estradiol
Progesterone
Estradiol cypionate
Estradiol valerate
Estradiol acetate
Estradiol hemihydrate
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 |
|---|---|
|
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
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:
|
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 Physiological Effects of Drugs Hormones Pharmacologic Actions Contraceptive Agents Reproductive Control Agents Therapeutic Uses Contraceptive Agents, Female Progestins |
ClinicalTrials.gov processed this record on May 16, 2013