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Sponsors and Collaborators: |
The Parkinson Study Group Wyeth Joseph and Rosalyn Newman Foundation |
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Information provided by: | The Parkinson Study Group |
ClinicalTrials.gov Identifier: | NCT00234676 |
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 |
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Parkinson's Disease |
Drug: Premarin ® |
Phase II |
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 |
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 |
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1: Experimental
Premarin
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Drug: Premarin ®
Premarin ® 0.625 mg per day orally
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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.
Ages Eligible for Study: | up to 75 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Principal Investigator: | Lisa M Shulman, MD | University of Maryland |
Responsible Party: | Parkinson Study Group Principal Investigator ( Lisa Shulman, MD ) |
Study ID Numbers: | POETRY06032003 |
Study First Received: | October 5, 2005 |
Last Updated: | December 24, 2007 |
ClinicalTrials.gov Identifier: | NCT00234676 History of Changes |
Health Authority: | United States: Institutional Review Board |
Parkinson disease women postmenopause estrogen replacement therapy clinical trials |
Estrogens Ganglion Cysts Hormone Antagonists Basal Ganglia Diseases Hormones, Hormone Substitutes, and Hormone Antagonists Central Nervous System Diseases Brain Diseases |
Neurodegenerative Diseases Hormones Estrogens, Conjugated (USP) Parkinson Disease Movement Disorders Parkinsonian Disorders Menopause |
Estrogens Basal Ganglia Diseases Nervous System Diseases Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Central Nervous System Diseases Brain Diseases |
Neurodegenerative Diseases Hormones Pharmacologic Actions Estrogens, Conjugated (USP) Parkinson Disease Movement Disorders Parkinsonian Disorders |