AFTER: Altering Fat Through Estrogen and Raloxifene

• Status: Completed
• Trial end date: 2006-02-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to determine whether estrogens specifically promote a reduction in fat from abdominal regions during weight loss and/or prevent the accumulation of abdominal fat during weight gain.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National Institute on Aging (NIA)
• Treatments: Estrogens; Estrogens, Conjugated (USP); Raloxifene Hydrochloride

Criteria

Inclusion Criteria:

• postmenopausal women

• aged 50-70 yr

• healthy, as determined by medical history, physical examination, blood chemistries, and a graded exercise stress test with monitoring of blood pressure and ECG

• good cognitive function.

Exclusion Criteria:

• contraindications to estrogen or raloxifene treatment, including history of or active breast cancer or other estrogen-dependent neoplasms, acute liver disease, undiagnosed vaginal bleeding, and active or history of blood clotting disorders

• mild or more severe cognitive impairment, indicated by a MMSE score <26

• clinically significant abnormal resting electrocardiogram (ECG), angina and/or ECG evidence of acute myocardial ischemia during a maximal exercise stress test

• resting blood pressure above 150 mmHg systolic or 90 mmHg diastolic

• left bundle branch blocks, A-V block greater than first degree, clinically significant arrhythmias

• congestive heart failure

• pulmonary emboli in the previous 6 months

• aortic stenosis

• chronic infections

• orthopedic or other problems that would interfere with participation in the exercise program