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| Sponsor: | University of Michigan Health System |
|---|---|
| Collaborator: |
National Institute on Aging (NIA) |
| Information provided by: | University of Michigan Health System |
| ClinicalTrials.gov Identifier: | NCT01046643 |
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 |
|---|---|
|
Postmenopausal |
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 |
| Estimated Enrollment: | 36 |
| Study Start Date: | April 2009 |
| Estimated Study Completion Date: | March 2011 |
| Estimated Primary Completion Date: | March 2011 (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
|
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:
Exclusion Criteria:
Contacts and Locations| Contact: Anne Tkaczyk, M.S. | 734-647-7266 | tkaczyk@umich.edu |
| Contact: Yolanda R Smith, M.D. | 734-936-7401 | ysmith@med.umich.edu |
| United States, Michigan | |
| University of Michigan Medical Center | Recruiting |
| Ann Arbor, Michigan, United States, 48109 | |
| Contact: Anne Tkaczyk, M.S. 734-647-7266 tkaczyk@umich.edu | |
| Contact: Yolanda R. Smith, M.D. | |
| Principal Investigator: Yolanda R. Smith, M.D. | |
| Principal Investigator: | Yolanda R. Smith, M.D. | University of Michigan Health System |
More Information
| Responsible Party: | Yolanda Smith, M.D., University of Michigan Medical School |
| ClinicalTrials.gov Identifier: | NCT01046643 History of Changes |
| Other Study ID Numbers: | 1R21AG031951 - 01A1, 1R21AG031951-01A1 |
| Study First Received: | January 11, 2010 |
| Last Updated: | June 24, 2010 |
| Health Authority: | United States: Institutional Review Board |
|
Women Healthy Postmenopausal Hormone treatment |
|
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 |
