Status:
COMPLETED
POETRY: Study of Estrogen Replacement Therapy in Postmenopausal Women With Parkinson's Disease
Lead Sponsor:
The Parkinson Study Group
Collaborating Sponsors:
Wyeth is now a wholly owned subsidiary of Pfizer
Joseph and Rosalyn Newman Foundation
Conditions:
Parkinson's Disease
Eligibility:
FEMALE
Up to 75 years
Phase:
PHASE2
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 recruitme...
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 tol...
Eligibility Criteria
Inclusion
- 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
- Insulin dependent diabetes
- Thyroid disease
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2006
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00234676
Start Date
October 1 2003
End Date
March 1 2006
Last Update
January 8 2008
Active Locations (6)
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1
The Parkinson's Institute
Sunnyvale, California, United States
2
Emory University
Atlanta, Georgia, United States
3
Indiana University School of Medicine
Indianapolis, Indiana, United States
4
University of Maryland
Baltimore, Maryland, United States