Early Menopause Hormone Treatment and Cognition (R21)
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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 |
- 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).
- 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 |
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| United States, Michigan | |
| The University of Michigan | |
| Ann Arbor, Michigan, United States, 48109 | |
| 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 June 18, 2013