Early Menopause Hormone Treatment and Cognition

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

The objective of this study is to evaluate the neurobiological effects of hormone therapy (HT) in healthy early postmenopausal women. The studies proposed in this project seek to define the association between different hormone forms (estradiol only and progesterone only) versus placebo on brain functional measures. The functional measures will include the performance of the volunteers on a comprehensive neuropsychological testing battery, and the brain functional responses to episodic memory (verbal and non-verbal) challenges as well as emotional processing determined with functional magnetic resonance imaging (fMRI).

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Michigan
• Collaborator: National Institute on Aging (NIA)
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Estrogens; Hormones; Polyestradiol phosphate; Progesterone

Criteria

Inclusion Criteria:

• Postmenopausal women

• Ages 45-55, 6 - 36 months from their last menstrual period.

Exclusion Criteria:

• Left handedness

• Acute medical illness

• Neurologic illness

• Psychiatric illness

• Heart disease

• Thromboembolic disease

• Liver disease

• Uncorrected thyroid disease

• Diabetes

• Neurological disease

• Porphyria

• Allergy to estradiol

• Progesterone or lactose

• Lactose intolerance

• Claustrophobia

• Contraindications to MRI (including pacemakers, surgical clips or metallic surgical devices)

• Smoking within the last 3 years

• Use of hormones within the last 3 months

• Current or past history of substance abuse

• History of head injury or loss of consciousness

• Medications with actions on the central nervous system

• Endometrial lining greater than 5mm

• Ovarian pathology on ultrasound

• Abnormal mammogram

• Migraines

• Fasting cholesterol >300 mg/dl, and fasting triglycerides >300 mg/dl

• Creatinine level > 1.5 mg/dl

• Aspartate transaminase (AST) or Alanine transaminase (ALT) greater than two times the top normal range

• Follicle stimulating hormone (FSH) values <40 IU/L

• estradiol >40 pg/ml.

• Subjects with HAM-D score > 8, HAM-A > 6 during screening will not be eligible.