Trial record 1 of 1 for:    Hormones and Cognitive Processing in Early Postmenopausal Women
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Early Menopause Hormone Treatment and Cognition (R21)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by University of Michigan.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Yolanda Smith, M.D., University of Michigan Health System
ClinicalTrials.gov Identifier:
NCT01046643
First received: January 11, 2010
Last updated: February 10, 2012
Last verified: February 2012

January 11, 2010
February 10, 2012
March 2010
March 2012   (final data collection date for primary outcome measure)
Brain activization patterns determined with the fMRI scans [ Time Frame: August 2010 - March 2012 ] [ Designated as safety issue: No ]
The goal of this study is to measure the changes in brain activity with hormone use (either estradiol or progesterone versus placebo).
It is expected that with estradiol treatment fMRI activation will be more prominent in the hippocampus and prefrontal cortical areas compared to placebo. [ Time Frame: After data acquisition ends in March 2011 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01046643 on ClinicalTrials.gov Archive Site
Neuropsychological testing [ Time Frame: August 2010 - March 2012 ] [ Designated as safety issue: No ]
It is expected that with progesterone treatment fMRI activation in the hippocampus and prefrontal cortical areas will be decreased compared to both the placebo condition (within subjects) and the estradiol condition (between subjects). [ Time Frame: After data acquisition ends in March 2011 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Early Menopause Hormone Treatment and Cognition
Hormones and Cognitive Processing in Early Postmenopausal Women

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 fMRI.

Specific Aims

Aim 1. To examine the effects of estradiol alone on brain functioning in early post-menopausal women during verbal and non-verbal cognitive tasks.

Hypothesis: It is expected that with estradiol treatment brain activation will be more prominent in the hippocampus and prefrontal cortical areas compared to placebo. The magnitude of activation in these regions will be positively correlated with task performance in the scanner and with the results of neuropsychological tests assessing verbal and non-verbal delayed recall.

Aim 2. To determine the effects of progesterone alone on brain functioning in early postmenopausal women during verbal and non-verbal cognitive tasks.

Hypothesis: It is expected that with progesterone treatment brain activation in the hippocampus and prefrontal cortical areas will be decreased compared to both the placebo condition (within subjects) and the estradiol condition (between subjects). Interindividual variations in the magnitude of activation in these regions will be positively correlated with task performance in the scanner and with the results of neuropsychological tests assessing verbal and non-verbal delayed recall.

Aim 3. To determine the individual effects of estradiol and progesterone on brain functioning in early postmenopausal women during emotional processing stimuli.

Hypothesis: During negative stimuli estradiol-treated women compared to placebo group, are expected to have increased activity in the amygdala, posterior cingulate, and orbitofrontal cortex, while in progesterone-treated women compared to placebo, decreased activity is expected in these brain regions.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Menopausal
  • Drug: Estradiol (E2)
    One Estradiol capsule (1mg) once a day, at the same time each day, for 90 days
    Other Name: E2
  • Drug: Progesterone (P10)
    One Progesterone (200 mg) capsule once a day, at the same time each day, for 90 days
    Other Name: P10
  • Active Comparator: Estrogen
    Estrogen treatment
    Intervention: Drug: Estradiol (E2)
  • Active Comparator: Progesterone
    Progesterone treatment
    Intervention: Drug: Progesterone (P10)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
36
March 2012
March 2012   (final data collection date for primary outcome measure)

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
  • AST or ALT greater than two times the top normal range
  • FSH values <40 IU/L
  • estradiol >40 pg/ml.
  • Subjects with HAM-D score > 8, HAM-A > 6 during screening will not be eligible.
Female
45 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01046643
1R21AG031951 - 01A1, 1R21AG031951-01A1
Yes
Yolanda Smith, M.D., University of Michigan Health System
University of Michigan
National Institute on Aging (NIA)
Principal Investigator: Yolanda R. Smith, M.D. University of Michigan
University of Michigan
February 2012

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