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”

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 Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study

Study Primary Completion Date: March 2006

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.

Intervention(s) in this Clinical Trial

• Drug: Premarin ®
  • Premarin ® 0.625 mg per day orally

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Premarin

Primary Measures

• Safety - Adverse event frequency, vital signs (change from Baseline to Month 2)
  • Time Frame: 60 days
    Safety Issue?: Yes
• Tolerability - Proportion of participants who complete the trial
  • Time Frame: 60 days
    Safety Issue?: Yes

Secondary Measures

• Motor
  • Time Frame: 60 days
    Safety Issue?: No
• Cognition
  • Time Frame: 60 days
    Safety Issue?: No
• Behavior
  • Time Frame: 60 days
    Safety Issue?: No
• Serum estradiol levels - change from Baseline to Month 2
  • Time Frame: 60 days
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: The Parkinson Study Group

Overall Clinical Trial Officials and Contacts

Lisa M Shulman, MD Principal Investigator University of Maryland  

Information obtained from ClinicalTrials.gov on August 28, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00234676

Study ID Number: POETRY06032003

ClinicalTrials.gov Identifier: NCT00234676

Health Authority: United States: Institutional Review Board

Parkinson Study Group