POETRY: Study of Estrogen Replacement Therapy in Postmenopausal Women With Parkinson's Disease
A Multi-Center, Double Blind, Randomized, Placebo-Controlled, Parallel Group Study for the Safety, Tolerability and Efficacy of Estrogen Replacement Therapy (Conjugated Equine Estrogens 0.625 mg Daily) in Post Menopausal Women With Parkinson's Disease
1 other identifier
interventional
23
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Oct 2003
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2003
CompletedFirst Submitted
Initial submission to the registry
October 5, 2005
CompletedFirst Posted
Study publicly available on registry
October 7, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2006
CompletedJanuary 8, 2008
December 1, 2007
2.4 years
October 5, 2005
December 24, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (4)
Motor
60 days
Cognition
60 days
Behavior
60 days
Serum estradiol levels - change from Baseline to Month 2
60 days
Study Arms (1)
1
EXPERIMENTALPremarin
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Insulin dependent diabetes
- Thyroid disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The Parkinson Study Grouplead
- Wyeth is now a wholly owned subsidiary of Pfizercollaborator
- Joseph and Rosalyn Newman Foundationcollaborator
Study Sites (6)
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
University of Rochester
Rochester, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lisa M Shulman, MD
University of Maryland
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
Study Record Dates
First Submitted
October 5, 2005
First Posted
October 7, 2005
Study Start
October 1, 2003
Primary Completion
March 1, 2006
Study Completion
March 1, 2006
Last Updated
January 8, 2008
Record last verified: 2007-12