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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

October 5, 2005
December 24, 2007
October 2003
March 2006   (final data collection date for primary outcome measure)
  • 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 ]
  • Safety - Adverse event frequency, vital signs (change from Baseline to Month 2)
  • Tolerability - Proportion of participants who complete the trial
Complete list of historical versions of study NCT00234676 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Motor
  • Cognition
  • Behavior
  • Serum estradiol levels - change from Baseline to Month 2
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Parkinson's Disease
Drug: Premarin ®
Premarin ® 0.625 mg per day orally
Experimental: 1
Premarin
Intervention: Drug: Premarin ®
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
23
March 2006
March 2006   (final data collection date for primary outcome measure)

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
Female
up to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00234676
POETRY06032003
Not Provided
Lisa Shulman, MD, Parkinson Study Group Principal Investigator
The Parkinson Study Group
  • Wyeth is now a wholly owned subsidiary of Pfizer
  • Joseph and Rosalyn Newman Foundation
Principal Investigator: Lisa M Shulman, MD University of Maryland
The Parkinson Study Group
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP