Early Menopause Hormone Treatment and Cognition
Completed · Not applicable · Has a placebo group
Conditions studied: Menopausal Syndrome
In brief
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).
Key facts
- Study ID
- NCT01046643
- Run by
- University of Michigan
- People needed
- 30
- Starts
- 2010-05-01
- Expected to finish
- 2012-03-01
- Last updated by the study team
- 2014-05-19
Who can join
Age: 45 and older, up to 55. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Postmenopausal women
- Ages 45-55, 6 - 36 months from their last menstrual period.
You may not qualify if…
- 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
Where it is running
- The University of Michigan — Ann Arbor, Michigan, United States
Full record on ClinicalTrials.gov
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