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
  Purpose

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.


Condition Intervention
Menopausal
Drug: Estradiol (E2)
Drug: Progesterone (P10)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Hormones and Cognitive Processing in Early Postmenopausal Women

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • Neuropsychological testing [ Time Frame: August 2010 - March 2012 ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: March 2010
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Estrogen
Estrogen treatment
Drug: Estradiol (E2)
One Estradiol capsule (1mg) once a day, at the same time each day, for 90 days
Other Name: E2
Active Comparator: Progesterone
Progesterone treatment
Drug: Progesterone (P10)
One Progesterone (200 mg) capsule once a day, at the same time each day, for 90 days
Other Name: P10

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   45 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01046643

Locations
United States, Michigan
The University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Yolanda R. Smith, M.D. University of Michigan
  More Information

No publications provided

Responsible Party: Yolanda Smith, M.D., Professor, University of Michigan Health System
ClinicalTrials.gov Identifier: NCT01046643     History of Changes
Other Study ID Numbers: 1R21AG031951 - 01A1, 1R21AG031951-01A1
Study First Received: January 11, 2010
Last Updated: February 10, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
Women
Healthy
Menopausal
Hormone treatment

Additional relevant MeSH terms:
Estradiol
Polyestradiol phosphate
Hormones
Progesterone
Estradiol valerate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estrogens
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptive Agents, Female
Progestins

ClinicalTrials.gov processed this record on April 15, 2014