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POETRY: Study of Estrogen Replacement Therapy in Postmenopausal Women With Parkinson's Disease

This study has been completed.

Sponsors and Collaborators: The Parkinson Study Group
Wyeth
Joseph and Rosalyn Newman Foundation
Information provided by: The Parkinson Study Group
ClinicalTrials.gov Identifier: NCT00234676
  Purpose

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.


Condition Intervention Phase
Parkinson's Disease
Drug: Premarin ®
Phase II

Genetics Home Reference related topics:   familial paroxysmal nonkinesigenic dyskinesia    Parkinson disease   

MedlinePlus related topics:   Parkinson's Disease   

ChemIDplus related topics:   Estrogens, conjugated   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study
Official Title:   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

Further study details as provided by The Parkinson Study Group:

Primary Outcome Measures:
  • Safety - Adverse event frequency, vital signs (change from Baseline to Month 2) [ Time Frame: 60 days ] [ Designated as safety issue: Yes ]
  • Tolerability - Proportion of participants who complete the trial [ Time Frame: 60 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Motor [ Time Frame: 60 days ] [ Designated as safety issue: No ]
  • Cognition [ Time Frame: 60 days ] [ Designated as safety issue: No ]
  • Behavior [ Time Frame: 60 days ] [ Designated as safety issue: No ]
  • Serum estradiol levels - change from Baseline to Month 2 [ Time Frame: 60 days ] [ Designated as safety issue: No ]

Enrollment:   23
Study Start Date:   October 2003
Study Completion Date:   March 2006
Primary Completion Date:   March 2006 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
Premarin
Drug: Premarin ®
Premarin ® 0.625 mg per day orally

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.

  Eligibility
Ages Eligible for Study:   up to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00234676

Locations
United States, California
The Parkinson's Institute    
      Sunnyvale, California, United States
United States, Georgia
Emory University    
      Atlanta, Georgia, United States
United States, Indiana
Indiana University School of Medicine    
      Indianapolis, Indiana, United States
United States, Maryland
University of Maryland    
      Baltimore, Maryland, United States
United States, New York
University of Rochester    
      Rochester, New York, United States
United States, North Carolina
Duke University Medical Center    
      Durham, North Carolina, United States

Sponsors and Collaborators
The Parkinson Study Group
Wyeth
Joseph and Rosalyn Newman Foundation

Investigators
Principal Investigator:     Lisa M Shulman, MD     University of Maryland    
  More Information


Parkinson Study Group  This link exits the ClinicalTrials.gov site
 

Responsible Party:   Parkinson Study Group Principal Investigator ( Lisa Shulman, MD )
Study ID Numbers:   POETRY06032003
First Received:   October 5, 2005
Last Updated:   December 24, 2007
ClinicalTrials.gov Identifier:   NCT00234676
Health Authority:   United States: Institutional Review Board

Keywords provided by The Parkinson Study Group:
Parkinson disease  
women  
postmenopause  
estrogen replacement therapy  
clinical trials  

Study placed in the following topic categories:
Estrogens, Conjugated (USP)
Ganglion Cysts
Movement Disorders
Parkinson Disease
Basal Ganglia Diseases
Central Nervous System Diseases
Parkinsonian Disorders
Neurodegenerative Diseases
Brain Diseases
Menopause

Additional relevant MeSH terms:
Estrogens
Physiological Effects of Drugs
Nervous System Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 17, 2008




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