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

This study has been completed.
Sponsor:
Collaborators:
Wyeth is now a wholly owned subsidiary of Pfizer
Joseph and Rosalyn Newman Foundation
Information provided by:
The Parkinson Study Group
ClinicalTrials.gov Identifier:
NCT00234676
First received: October 5, 2005
Last updated: December 24, 2007
Last verified: December 2007
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


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
Experimental: 1
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 is now a wholly owned subsidiary of Pfizer
Joseph and Rosalyn Newman Foundation
Investigators
Principal Investigator: Lisa M Shulman, MD University of Maryland
  More Information

Additional Information:
No publications provided

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

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

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 16, 2014