POETRY: Study of Estrogen Replacement Therapy in Postmenopausal Women With Parkinson's Disease
- Registration Number
- NCT00234676
- Lead Sponsor
- The Parkinson Study Group
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 23
- 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)
- Insulin dependent diabetes
- Thyroid disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Premarin ® Premarin
- Primary Outcome Measures
Name Time Method 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
Name Time Method Motor 60 days Cognition 60 days Behavior 60 days Serum estradiol levels - change from Baseline to Month 2 60 days
Trial Locations
- Locations (6)
The Parkinson's Institute
🇺🇸Sunnyvale, California, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Emory University
🇺🇸Atlanta, Georgia, United States
University of Maryland
🇺🇸Baltimore, Maryland, United States
University of Rochester
🇺🇸Rochester, New York, United States
Indiana University School of Medicine
🇺🇸Indianapolis, Indiana, United States