Parkinson's Disease
Conditions
Keywords
Parkinson disease, women, postmenopause, estrogen replacement therapy, clinical trials
Brief summary
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.
Detailed description
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.
Interventions
DRUGPremarin ®
Premarin ® 0.625 mg per day orally
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Joseph and Rosalyn Newman Foundation
The Parkinson Study Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
No minimum to 75 Years
Healthy volunteers
No
Inclusion criteria
* Post-menopausal women with Parkinson's disease who experience levodopa-related motor fluctuations averaging at least 2 hours daily in the off state confirmed by home diaries * Must be on a stable dose of carbidopa/levodopa, immediate or controlled release therapy, antidepressants, or anxiolytics (for the last 30 days)
Exclusion criteria
* Insulin dependent diabetes * Thyroid disease
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame |
|---|---|
| Motor | 60 days |
| Cognition | 60 days |
| Behavior | 60 days |
| Serum estradiol levels - change from Baseline to Month 2 | 60 days |
Countries
United States
Outcome results
None listed