The primary objectives of the POETRY study are to assess the safety and tolerability of estrogen replacement therapy (ERT) in postmenopausal women with Parkinson's disease (PD) and to assess recruitment for a study of ERT in postmenopausal women with PD.
POETRY is an 8-week study of 30 post-menopausal women with Parkinson's disease (PD) who will be enrolled at six clinical sites in the United States. The study is designed to measure the safety and tolerability of estrogen replacement therapy (ERT). The study will also measure how ERT affects thinking and behavior, movement and activities of daily living, as well as motor fluctuations and dyskinesias. Although we know there are gender differences in PD, no studies have assessed their impact on symptom management. Women with PD usually require less levodopa, are more likely to experience drug-related dyskinesia, and commonly report changes of their symptoms with menstruation, menopause and use of hormones, implying that hormonal changes may impact PD symptoms. All perimenopausal women face the decision whether or not to use estrogen replacement therapy (ERT) and for women with PD, information about estrogen's effects in PD may facilitate decision-making.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
23
Premarin ® 0.625 mg per day orally
The Parkinson's Institute
Sunnyvale, California, United States
Emory University
Atlanta, Georgia, United States
Indiana University School of Medicine
Indianapolis, Indiana, United States
University of Maryland
Baltimore, Maryland, United States
Safety - Adverse event frequency, vital signs (change from Baseline to Month 2)
Time frame: 60 days
Tolerability - Proportion of participants who complete the trial
Time frame: 60 days
Motor
Time frame: 60 days
Cognition
Time frame: 60 days
Behavior
Time frame: 60 days
Serum estradiol levels - change from Baseline to Month 2
Time frame: 60 days
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University of Rochester
Rochester, New York, United States
Duke University Medical Center
Durham, North Carolina, United States