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| Name | Class |
|---|---|
| Wyeth is now a wholly owned subsidiary of Pfizer | INDUSTRY |
| Joseph and Rosalyn Newman Foundation | UNKNOWN |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Premarin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Premarin ® | Drug | Premarin ® 0.625 mg per day orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety - Adverse event frequency, vital signs (change from Baseline to Month 2) | 60 days | |
| Tolerability - Proportion of participants who complete the trial | 60 days |
| Measure | Description | Time Frame |
|---|---|---|
| Motor | 60 days | |
| Cognition | 60 days | |
| Behavior |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa M Shulman, MD | University of Maryland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Parkinson's Institute | Sunnyvale | California | United States | |||
| Emory University |
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| Label | URL |
|---|---|
| Parkinson Study Group | View source |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D004966 | Estrogens, Conjugated (USP) |
| ID | Term |
|---|---|
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
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| 60 days |
| Serum estradiol levels - change from Baseline to Month 2 | 60 days |
| Atlanta |
| Georgia |
| United States |
| Indiana University School of Medicine | Indianapolis | Indiana | United States |
| University of Maryland | Baltimore | Maryland | United States |
| University of Rochester | Rochester | New York | United States |
| Duke University Medical Center | Durham | North Carolina | United States |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |