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

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.

Study Overview

• Status: Completed
• Conditions: Parkinson's Disease
• Intervention / Treatment: Drug: Premarin ®

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.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Premarin	Drug: Premarin ®; Premarin ® 0.625 mg per day orally

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Time Frame
Motor	60 days
Cognition	60 days
Behavior	60 days
Serum estradiol levels - change from Baseline to Month 2	60 days

Collaborators and Investigators

• Sponsor: The Parkinson Study Group
• Collaborators: Wyeth is now a wholly owned subsidiary of Pfizer; Joseph and Rosalyn Newman Foundation
• Investigators: Principal Investigator: Lisa M Shulman, MD, University of Maryland

Publications and helpful links

Helpful Links

• Parkinson Study Group

Study record dates

Study Major Dates

• Study Start: October 1, 2003
• Primary Completion (Actual): March 1, 2006
• Study Completion (Actual): March 1, 2006

Study Registration Dates

• First Submitted: October 5, 2005
• First Submitted That Met QC Criteria: October 5, 2005
• First Posted (Estimate): October 7, 2005

Study Record Updates

• Last Update Posted (Estimate): January 8, 2008
• Last Update Submitted That Met QC Criteria: December 24, 2007
• Last Verified: December 1, 2007

More Information

Terms related to this study

• Keywords: clinical trials; Parkinson disease; women; postmenopause; estrogen replacement therapy
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Estrogens; Estrogens, Conjugated (USP)
• Other Study ID Numbers: POETRY06032003