N/A N=30 Randomized Quadruple-blind Treatment

Early Menopause Hormone Treatment and Cognition

Menopausal Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT01046643 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2014

Primary outcome: Primary: Changes in Brain Activation Patterns in Verbal Tasks Determined With the Functional Magnetic Resonance Imaging (fMRI) Scans — .14; .13; .05; .13 percent BOLD signal changes — p=.222

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Estradiol (E2) (Drug); Progesterone (P10) x90 (Drug); Progesterone (P10) x10 (Drug)
Age: Adult · 45+ yrs
Sex: Female
Sponsor: University of Michigan
Primary completion: Mar 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Changes in Brain Activation Patterns in Verbal Tasks Determined With the Functional Magnetic Resonance Imaging (fMRI) Scans	.14; .13; .05; .13; -.04; -.01	.222
PRIMARY Changes in Brain Activation Patterns in Visual Tasks Determined With the Functional Magnetic Resonance Imaging (fMRI) Scans	.25; .47; .16; .20; .21; .38	.452
SECONDARY Neuropsychological Testing Scores - Verbal Learning Retention	96.79; 97.12; 94.94; 98.44	.594
SECONDARY Neuropsychological Testing Scores - Visual Learning Retention	93.31; 97.59; 97.01; 96.19	.561

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).

Eligibility 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 pg/ml.
Subjects with HAM-D score > 8, HAM-A > 6 during screening will not be eligible.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01046643). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.